Effects of Transcutaneous Electrical Nerve Stimulation (TENS) to Improve the Cognitive Functions in Older Adults

September 20, 2023 updated by: Shamay Ng, The Hong Kong Polytechnic University

A Randomized Controlled Clinical Trial of Transcutaneous Electrical Nerve Stimulation to Improve the Cognitive Functions in Older Adults

Recent evidence has shown that transcutaneous electrical nerve stimulation (TENS) was effective in improving the cognitive function in healthy adult and people with dementia. However, lacking of evidence investigated the effect of TENS in improving the cognitive function and reversing the occurrence of dementia during the period of mild cognitive impairment (MCI), which is the crucial period to prevent the significant loss of cognition function. Therefore, the main objective of this study is to investigate the optimal TENS treatment protocol in improving the cognitive function in older adults with MCI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to investigate the effectiveness of 3 intervention protocols (1) In the T1 TENS group, the subject will receive TENS on T1 spine. (2) In the vagus nerve TENS group, the subject will receive TENS on the concha of left outer ear. (3) In the sham stimulation group, the subject will receive sham stimulation on the T1 spine, in improving the cognitive function in older adults with MCI.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Should fulfil the diagnosis criteria of MCI (Albert et al., 2011):

  1. Concern regarding a change in cognition
  2. Impairment in one or more cognitive domains
  3. Preservation of independence in functional abilities
  4. no signs of dementia were to be present and confirmed by the medical staff and medical records.

Exclusion Criteria:

  1. If their medical records reported a history of either psychiatric disorder, alcoholism, cerebral trauma, cerebrovascular disease, hydrocephalus, neoplasm, epilepsy, disturbances of consciousness, insulin-dependent diabetes mellitus or focal brain disorders;
  2. Having active implants, such as cochlear implants, pacemaker;
  3. Having wounds and diseased skin on the electrode position.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T1 TENS
In this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks
Device: T1 TENS
The subjects in Group A will received TENS (Burst mode, 9 pulses per burst, pulse frequency =160Hz, burst frequency=2Hz, intensity was set to trigger visible muscular twitches). Two 2 x 3 cm electrodes was attached on T1 level with 2 cm from the spine. Previous study has shown that it was effective to improve the cognitive function in subjects with Alzheimer's disease.
Experimental: Concha TENS
In this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks
Device: Concha TENS
The subjects in Group B will received TENS (25Hz, 0.5mA) on the concha of left outer ear. The electrical stimulation was generated by the portable neurostimulator (Nemos®, Cerbomed, Erlangen, Germany) and was delivered by a titanium electrodes positioning on top of a silicon earplug. Previous study has shown that it was effective to improve the Accelerate extinction memory formation and retention in healthy young adults.
Placebo Comparator: Control
In this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks
Device: Control
The subjects in Group C will receive 30 min sham electrical stimulation on T1 by a placebo-TENS device. The Placebo-TENS was applied by an apparently identical TENS unit. The unit's power indicator light was illuminated, but the unit's electrical circuit had been manually disconnected inside. In order to shape the common mindset, all subjects (except those in the Control group) were informed that they might or might not feel an electrical current, as different stimulation parameters were being applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal cognitive assessment (MoCA)
Time Frame: Baseline (0 week)
The overall cognitive function is measured by the Cantonese version of MoCA. The MoCA is a widely used 10-minute cognitive screening test for detection of MCI. The MoCA test includes 8 parts with a maximum score of 30. A higher score indicated a better cognitive function. The Cantonese version of MoCA has shown good to excellent inter-rater (ICC=0.987, p<0.001) reliability in Chinese older adults.
Baseline (0 week)
Montreal cognitive assessment (MoCA)
Time Frame: Mid-intervention (5 week)
The overall cognitive function is measured by the Cantonese version of MoCA. The MoCA is a widely used 10-minute cognitive screening test for detection of MCI. The MoCA test includes 8 parts with a maximum score of 30. A higher score indicated a better cognitive function. The Cantonese version of MoCA has shown good to excellent inter-rater (ICC=0.987, p<0.001) reliability in Chinese older adults.
Mid-intervention (5 week)
Montreal cognitive assessment (MoCA)
Time Frame: Post-intervention (10 week)
The overall cognitive function is measured by the Cantonese version of MoCA. The MoCA is a widely used 10-minute cognitive screening test for detection of MCI. The MoCA test includes 8 parts with a maximum score of 30. A higher score indicated a better cognitive function. The Cantonese version of MoCA has shown good to excellent inter-rater (ICC=0.987, p<0.001) reliability in Chinese older adults.
Post-intervention (10 week)
Montreal cognitive assessment (MoCA)
Time Frame: 1 month follow-up (14 week)
The overall cognitive function is measured by the Cantonese version of MoCA. The MoCA is a widely used 10-minute cognitive screening test for detection of MCI. The MoCA test includes 8 parts with a maximum score of 30. A higher score indicated a better cognitive function. The Cantonese version of MoCA has shown good to excellent inter-rater (ICC=0.987, p<0.001) reliability in Chinese older adults.
1 month follow-up (14 week)
Digit Span Test
Time Frame: Baseline (0 week)
The verbal short-term memory and working memory is measured by the digit span test. The subject was required to listen to a series of random numbers carefully and then repeated them in forward (forward digit span test) and backward (backward digit span test) order. Continue in the same manner by increasing the series of numbers. The difficulty will be increased when the number in a sequence increased. The forward digit span task requires verbal working memory and attention, while the backwards digit span task additionally tests cognitive control and executive function. The more correct trials performed indicated better short-term memory and work memory.
Baseline (0 week)
Digit Span Test
Time Frame: Mid-intervention (5 week)
The verbal short-term memory and working memory is measured by the digit span test . The subject was required to listen to a series of random numbers carefully and then repeated them in forward (forward digit span test) and backward (backward digit span test) order. Continue in the same manner by increasing the series of numbers. The difficulty will be increased when the number in a sequence increased. The forward digit span task requires verbal working memory and attention, while the backwards digit span task additionally tests cognitive control and executive function.The more correct trials performed indicated better short-term memory and work memory.
Mid-intervention (5 week)
Digit Span Test
Time Frame: Post-intervention (10 week)
The verbal short-term memory and working memory is measured by the digit span test. The subject was required to listen to a series of random numbers carefully and then repeated them in forward (forward digit span test) and backward (backward digit span test) order. Continue in the same manner by increasing the series of numbers. The difficulty will be increased when the number in a sequence increased. The forward digit span task requires verbal working memory and attention, while the backwards digit span task additionally tests cognitive control and executive function.The more correct trials performed indicated better short-term memory and work memory.
Post-intervention (10 week)
Digit Span Test
Time Frame: 1 month follow-up (14 week)
The verbal short-term memory and working memory is measured by the digit span test . The subject was required to listen to a series of random numbers carefully and then repeated them in forward (forward digit span test) and backward (backward digit span test) order. Continue in the same manner by increasing the series of numbers. The difficulty will be increased when the number in a sequence increased. The forward digit span task requires verbal working memory and attention, while the backwards digit span task additionally tests cognitive control and executive function.The more correct trials performed indicated better short-term memory and work memory.
1 month follow-up (14 week)
Visual Memory Span Test
Time Frame: Baseline (0 week)
The visual memory is measured by the visual memory span test. The subject was required to observe a given order to tap a number of block as shown by the examiners and then repeat them in forward and backward order. The difficulty will be increased when the number of blocks in a sequence increased. The more correct trials performed indicated better visual memory.
Baseline (0 week)
Visual Memory Span Test
Time Frame: Mid-intervention (5 week)
The visual memory is measured by the visual memory span test. The subject was required to observe a given order to tap a number of block as shown by the examiners and then repeat them in forward and backward order. The difficulty will be increased when the number of blocks in a sequence increased. The more correct trials performed indicated better visual memory.
Mid-intervention (5 week)
Visual Memory Span Test
Time Frame: Post-intervention (10 week)
The visual memory is measured by the visual memory span test. The subject was required to observe a given order to tap a number of block as shown by the examiners and then repeat them in forward and backward order. The difficulty will be increased when the number of blocks in a sequence increased. The more correct trials performed indicated better visual memory.
Post-intervention (10 week)
Visual Memory Span Test
Time Frame: 1 month follow-up (14 week)
The visual memory is measured by the visual memory span test. The subject was required to observe a given order to tap a number of block as shown by the examiners and then repeat them in forward and backward order. The difficulty will be increased when the number of blocks in a sequence increased. The more correct trials performed indicated better visual memory.
1 month follow-up (14 week)
Stroop Color and Word Test
Time Frame: Baseline (0 week)
The ability to inhibit cognitive interference is measured by the Stroop Color and Word Test. The Stroop Test consists of 3 subtasks. The first subtask shows color dots (green, blue, yellow, red) in random order. The second subtask shows the words (green, blue, red, yellow) in random order. The third task showed color words (green, blue, red, yellow) printed in a different ink color (i.e., the word blue printed in yellow ink). Participants are required to name the color of the ink as quickly as possible within 45 s in each task. The completion time and number of error is recorded in each task. The interference ratio of will be calculated as the completion time of the third task/the completion time of the first task. A higher interference score indicated poorer interference control.
Baseline (0 week)
Stroop Color and Word Test
Time Frame: Mid-intervention (5 week)
The ability to inhibit cognitive interference is measured by the Stroop Color and Word Test. The Stroop Test consists of 3 subtasks. The first subtask shows color dots (green, blue, yellow, red) in random order. The second subtask shows the words (green, blue, red, yellow) in random order. The third task showed color words (green, blue, red, yellow) printed in a different ink color (i.e., the word blue printed in yellow ink). Participants are required to name the color of the ink as quickly as possible within 45 s in each task. The completion time and number of error is recorded in each task. The interference ratio of will be calculated as the completion time of the third task/the completion time of the first task. A higher interference score indicated poorer interference control.
Mid-intervention (5 week)
Stroop Color and Word Test
Time Frame: Post-intervention (10 week)
The ability to inhibit cognitive interference is measured by the Stroop Color and Word Test. The Stroop Test consists of 3 subtasks. The first subtask shows color dots (green, blue, yellow, red) in random order. The second subtask shows the words (green, blue, red, yellow) in random order. The third task showed color words (green, blue, red, yellow) printed in a different ink color (i.e., the word blue printed in yellow ink). Participants are required to name the color of the ink as quickly as possible within 45 s in each task. The completion time and number of error is recorded in each task. The interference ratio of will be calculated as the completion time of the third task/the completion time of the first task. A higher interference score indicated poorer interference control.
Post-intervention (10 week)
Stroop Color and Word Test
Time Frame: 1 month follow-up (14 week)
The ability to inhibit cognitive interference is measured by the Stroop Color and Word Test. The Stroop Test consists of 3 subtasks. The first subtask shows color dots (green, blue, yellow, red) in random order. The second subtask shows the words (green, blue, red, yellow) in random order. The third task showed color words (green, blue, red, yellow) printed in a different ink color (i.e., the word blue printed in yellow ink). Participants are required to name the color of the ink as quickly as possible within 45 s in each task. The completion time and number of error is recorded in each task. The interference ratio of will be calculated as the completion time of the third task/the completion time of the first task. A higher interference score indicated poorer interference control.
1 month follow-up (14 week)
Face Recognition Test
Time Frame: Baseline (0 week)
The visual, nonverbal long-term memory is measured by the face recognition test from the Rivermead Behavioral Memory Test (RMBT). Fifteen faces are shown successively to the subject. After an occupied interval of 5 minutes, the subjects are required to select the original 15 faces from a set of 30. The recognition score is the number of correct answers minus the number of incorrect answers. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, nonverbal long term memory.
Baseline (0 week)
Face Recognition Test
Time Frame: Mid-intervention (5 week)
The visual, nonverbal long-term memory is measured by the face recognition test from the Rivermead Behavioral Memory Test (RMBT). Fifteen faces are shown successively to the subject. After an occupied interval of 5 minutes, the subjects are required to select the original 15 faces from a set of 30. The recognition score is the number of correct answers minus the number of incorrect answers. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, nonverbal long term memory.
Mid-intervention (5 week)
Face Recognition Test
Time Frame: Post-intervention (10 week)
The visual, nonverbal long-term memory is measured by the face recognition test from the Rivermead Behavioral Memory Test (RMBT). Fifteen faces are shown successively to the subject. After an occupied interval of 5 minutes, the subjects are required to select the original 15 faces from a set of 30. The recognition score is the number of correct answers minus the number of incorrect answers. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, nonverbal long term memory.
Post-intervention (10 week)
Face Recognition Test
Time Frame: 1 month follow-up (14 week)
The visual, nonverbal long-term memory is measured by the face recognition test from the Rivermead Behavioral Memory Test (RMBT). Fifteen faces are shown successively to the subject. After an occupied interval of 5 minutes, the subjects are required to select the original 15 faces from a set of 30. The recognition score is the number of correct answers minus the number of incorrect answers. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, nonverbal long term memory.
1 month follow-up (14 week)
Picture Recognition Test
Time Frame: Baseline (0 week)
The visual, verbal long-term memory is measured by the picture recognition test from the RBMT. Line drawings of 15 common objects are presented one at a time. After an occupied interval of 5 minutes, the subjects are asked to select the original 15 pictures from a set of 30. The recognition score is calculated in the same way as in the Face Recognition test. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, verbal long term memory.
Baseline (0 week)
Picture Recognition Test
Time Frame: Mid-intervention (5 week)
The visual, verbal long-term memory is measured by the picture recognition test from the RBMT. Line drawings of 15 common objects are presented one at a time. After an occupied interval of 5 minutes, the subjects are asked to select the original 15 pictures from a set of 30. The recognition score is calculated in the same way as in the Face Recognition test. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, verbal long term memory.
Mid-intervention (5 week)
Picture Recognition Test
Time Frame: Post-intervention (10 week)
The visual, verbal long-term memory is measured by the picture recognition test from the RBMT. Line drawings of 15 common objects are presented one at a time. After an occupied interval of 5 minutes, the subjects are asked to select the original 15 pictures from a set of 30. The recognition score is calculated in the same way as in the Face Recognition test. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, verbal long term memory.
Post-intervention (10 week)
Picture Recognition Test
Time Frame: 1 month follow-up (14 week)
The visual, verbal long-term memory is measured by the picture recognition test from the RBMT. Line drawings of 15 common objects are presented one at a time. After an occupied interval of 5 minutes, the subjects are asked to select the original 15 pictures from a set of 30. The recognition score is calculated in the same way as in the Face Recognition test. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, verbal long term memory.
1 month follow-up (14 week)
Berg Balance Scale (BBS)
Time Frame: Baseline (0 week)
The functional balance ability is measured by BBS. The BBS is an ordinal scale with 14 items, each item ranged from 0-4 with a total score ranged from 0-56. The higher score indicates a better balance function. Previous study has shown that BBS has good to excellent test-retest reliability (ICC=0.77-0.886) in older adults.
Baseline (0 week)
Berg Balance Scale (BBS)
Time Frame: Mid-intervention (5 week)
The functional balance ability is measured by BBS. The BBS is an ordinal scale with 14 items, each item ranged from 0-4 with a total score ranged from 0-56. The higher score indicates a better balance function. Previous study has shown that BBS has good to excellent test-retest reliability (ICC=0.77-0.886) in older adults.
Mid-intervention (5 week)
Berg Balance Scale (BBS)
Time Frame: Post-intervention (10 week)
The functional balance ability is measured by BBS. The BBS is an ordinal scale with 14 items, each item ranged from 0-4 with a total score ranged from 0-56. The higher score indicates a better balance function. Previous study has shown that BBS has good to excellent test-retest reliability (ICC=0.77-0.886) in older adults.
Post-intervention (10 week)
Berg Balance Scale (BBS)
Time Frame: 1 month follow-up (14 week)
The functional balance ability is measured by BBS. The BBS is an ordinal scale with 14 items, each item ranged from 0-4 with a total score ranged from 0-56. The higher score indicates a better balance function. Previous study has shown that BBS has good to excellent test-retest reliability (ICC=0.77-0.886) in older adults.
1 month follow-up (14 week)
10 Meter Walking Test (10MWT)
Time Frame: Baseline (0 week)
The walking speed over a short distance is measured by the 10MWT. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is. 10MWT has shown excellent test-retest reliability (ICC=0.98) in assessing healthy older adults.
Baseline (0 week)
10 Meter Walking Test (10MWT)
Time Frame: Mid-intervention (5 week)
The walking speed over a short distance is measured by the 10MWT. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is. 10MWT has shown excellent test-retest reliability (ICC=0.98) in assessing healthy older adults.
Mid-intervention (5 week)
10 Meter Walking Test (10MWT)
Time Frame: Post-intervention (10 week)
The walking speed over a short distance is measured by the 10MWT. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is. 10MWT has shown excellent test-retest reliability (ICC=0.98) in assessing healthy older adults.
Post-intervention (10 week)
10 Meter Walking Test (10MWT)
Time Frame: 1 month follow-up (14 week)
The walking speed over a short distance is measured by the 10MWT. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is. 10MWT has shown excellent test-retest reliability (ICC=0.98) in assessing healthy older adults.
1 month follow-up (14 week)
6 Minutes Walking Test (6MWT)
Time Frame: Baseline (0 week)
The aerobic capacity and walking endurance is measured by the 6MWT. The participants will be asked to walk as far as possible for 6 minutes in the 20 meters' corridor. The walking distance in 6 minutes will be records. The longer distance the subject walk, the better endurance is. The 6MWT has shown excellent test-retest reliability (ICC=0.95) in assessing healthy older adults.
Baseline (0 week)
6 Minutes Walking Test (6MWT)
Time Frame: Mid-intervention (5 week)
The aerobic capacity and walking endurance is measured by the 6MWT. The participants will be asked to walk as far as possible for 6 minutes in the 20 meters' corridor. The walking distance in 6 minutes will be records. The longer distance the subject walk, the better endurance is. The 6MWT has shown excellent test-retest reliability (ICC=0.95) in assessing healthy older adults.
Mid-intervention (5 week)
6 Minutes Walking Test (6MWT)
Time Frame: Post-intervention (10 week)
The aerobic capacity and walking endurance is measured by the 6MWT. The participants will be asked to walk as far as possible for 6 minutes in the 20 meters' corridor. The walking distance in 6 minutes will be records. The longer distance the subject walk, the better endurance is. The 6MWT has shown excellent test-retest reliability (ICC=0.95) in assessing healthy older adults.
Post-intervention (10 week)
6 Minutes Walking Test (6MWT)
Time Frame: 1 month follow-up (14 week)
The aerobic capacity and walking endurance is measured by the 6MWT. The participants will be asked to walk as far as possible for 6 minutes in the 20 meters' corridor. The walking distance in 6 minutes will be records. The longer distance the subject walk, the better endurance is. The 6MWT has shown excellent test-retest reliability (ICC=0.95) in assessing healthy older adults.
1 month follow-up (14 week)
Time Up and Go Test (TUG)
Time Frame: Baseline (0 week)
The functional ability is measured by TUG. The subject will be asked to stand up from the chair, walk 3 meters, turn 180°, go back to the chair and then sit down. The completion time will be recorded. The subjects need to repeat the test for 2 times. The completion time of the 2 trials will be averaged.
Baseline (0 week)
Time Up and Go Test (TUG)
Time Frame: Mid-intervention (5 week)
The functional ability is measured by TUG. The subject will be asked to stand up from the chair, walk 3 meters, turn 180°, go back to the chair and then sit down. The completion time will be recorded. The subjects need to repeat the test for 2 times. The completion time of the 2 trials will be averaged.
Mid-intervention (5 week)
Time Up and Go Test (TUG)
Time Frame: Post-intervention (10 week)
The functional ability is measured by TUG. The subject will be asked to stand up from the chair, walk 3 meters, turn 180°, go back to the chair and then sit down. The completion time will be recorded. The subjects need to repeat the test for 2 times. The completion time of the 2 trials will be averaged.
Post-intervention (10 week)
Time Up and Go Test (TUG)
Time Frame: 1 month follow-up (14 week)
The functional ability is measured by TUG. The subject will be asked to stand up from the chair, walk 3 meters, turn 180°, go back to the chair and then sit down. The completion time will be recorded. The subjects need to repeat the test for 2 times. The completion time of the 2 trials will be averaged.
1 month follow-up (14 week)
Community Integration Measure
Time Frame: Baseline (0 week)
The level of community integration is assessed by Chinese version of Community Integration Measure (CIM). It is a self-report questionnaire that is easily administrated to assess the community integration level. The instrument consists of 10 items, each rated from 1 to 5, giving a total score ranging from 10 to 50. A higher score indicates greater community integration. Liu et al. (Liu et al., 2014) reports that the Chinese version of the CIM showed good test-retest reliability (ICC=0.84) in people with stroke. A pilot study with 123 people with chronic stroke conducted as part of this research showed that CIM scores were significantly correlated with peak wrist flexion torque (r=0.203, p<0.05), Wolf Motoro Function Test (WMFT) scores (r=0.194, p<0.05) and Barthel Index scores (r=0.194, p<0.05).
Baseline (0 week)
Community Integration Measure
Time Frame: Mid-intervention (5 week)
The level of community integration is assessed by Chinese version of Community Integration Measure (CIM). It is a self-report questionnaire that is easily administrated to assess the community integration level. The instrument consists of 10 items, each rated from 1 to 5, giving a total score ranging from 10 to 50. A higher score indicates greater community integration. Liu et al. reports that the Chinese version of the CIM showed good test-retest reliability (ICC=0.84) in people with stroke. A pilot study with 123 people with chronic stroke conducted as part of this research showed that CIM scores were significantly correlated with peak wrist flexion torque (r=0.203, p<0.05), WMFT scores (r=0.194, p<0.05) and Barthel Index scores (r=0.194, p<0.05).
Mid-intervention (5 week)
Community Integration Measure
Time Frame: Post-intervention (10 week)
The level of community integration is assessed by Chinese version of Community Integration Measure (CIM). It is a self-report questionnaire that is easily administrated to assess the community integration level. The instrument consists of 10 items, each rated from 1 to 5, giving a total score ranging from 10 to 50. A higher score indicates greater community integration. Liu et al. reports that the Chinese version of the CIM showed good test-retest reliability (ICC=0.84) in people with stroke. A pilot study with 123 people with chronic stroke conducted as part of this research showed that CIM scores were significantly correlated with peak wrist flexion torque (r=0.203, p<0.05), WMFT scores (r=0.194, p<0.05) and Barthel Index scores (r=0.194, p<0.05).
Post-intervention (10 week)
Community Integration Measure
Time Frame: 1 month follow-up (14 week)
The level of community integration is assessed by Chinese version of Community Integration Measure (CIM). It is a self-report questionnaire that is easily administrated to assess the community integration level. The instrument consists of 10 items, each rated from 1 to 5, giving a total score ranging from 10 to 50. A higher score indicates greater community integration. Liu et al. reports that the Chinese version of the CIM showed good test-retest reliability (ICC=0.84) in people with stroke. A pilot study with 123 people with chronic stroke conducted as part of this research showed that CIM scores were significantly correlated with peak wrist flexion torque (r=0.203, p<0.05), WMFT scores (r=0.194, p<0.05) and Barthel Index scores (r=0.194, p<0.05).
1 month follow-up (14 week)
Limit of Stability (LOS)-Reaction Time
Time Frame: Baseline (0 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Reaction time (RT) is used to assess the time participants take to give a movement response after cues are provided. The RT (second) in the 8 direction will be measured. The longer RT indicated poorer balance performance.
Baseline (0 week)
Limit of Stability (LOS)-Reaction Time
Time Frame: Mid-intervention (5 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Reaction time (RT) is used to assess the time participants take to give a movement response after cues are provided. The RT (second) in the 8 direction will be measured. The longer RT indicated poorer balance performance.
Mid-intervention (5 week)
Limit of Stability (LOS)-Reaction Time
Time Frame: Post-intervention (10 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Reaction time (RT) is used to assess the time participants take to give a movement response after cues are provided. The RT (second) in the 8 direction will be measured. The longer RT indicated poorer balance performance.
Post-intervention (10 week)
Limit of Stability (LOS)-Reaction Time
Time Frame: 1 month follow-up (14 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Reaction time (RT) is used to assess the time participants take to give a movement response after cues are provided. The RT (second) in the 8 direction will be measured. The longer RT indicated poorer balance performance.
1 month follow-up (14 week)
Limit of Stability (LOS)-Movement Velocity
Time Frame: Baseline (0 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Movement velocity (MV) is used to assess the average center of gravity (COG) displacement speed. The MV (degree/second) in the 8 direction will be measured. The smaller MV indicated poorer balance performance.
Baseline (0 week)
Limit of Stability (LOS)-Movement Velocity
Time Frame: Mid-intervention (5 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Movement velocity (MV) is used to assess the average center of gravity (COG) displacement speed. The MV (degree/second) in the 8 direction will be measured. The smaller MV indicated poorer balance performance.
Mid-intervention (5 week)
Limit of Stability (LOS)-Movement Velocity
Time Frame: Post-intervention (10 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Movement velocity (MV) is used to assess the average center of gravity (COG) displacement speed. The MV (degree/second) in the 8 direction will be measured. The smaller MV indicated poorer balance performance.
Post-intervention (10 week)
Limit of Stability (LOS)-Movement Velocity
Time Frame: 1 month follow-up (14 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Movement velocity (MV) is used to assess the average center of gravity (COG) displacement speed. The MV (degree/second) in the 8 direction will be measured. The smaller MV indicated poorer balance performance.
1 month follow-up (14 week)
Limit of Stability (LOS)-Endpoint Excursion
Time Frame: Baseline (0 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Endpoint excursion (EE) is used to assess how far the patient leans towards the target on his or her first attempt. The EE (%) in the 8 direction will be measured. The smaller EE indicated poorer balance performance.
Baseline (0 week)
Limit of Stability (LOS)-Endpoint Excursion
Time Frame: Mid-intervention (5 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Endpoint excursion (EE) is used to assess how far the patient leans towards the target on his or her first attempt. The EE (%) in the 8 direction will be measured. The smaller EE indicated poorer balance performance.
Mid-intervention (5 week)
Limit of Stability (LOS)-Endpoint Excursion
Time Frame: Post-intervention (10 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Endpoint excursion (EE) is used to assess how far the patient leans towards the target on his or her first attempt. The EE (%) in the 8 direction will be measured. The smaller EE indicated poorer balance performance.
Post-intervention (10 week)
Limit of Stability (LOS)-Endpoint Excursion
Time Frame: 1 month follow-up (14 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Endpoint excursion (EE) is used to assess how far the patient leans towards the target on his or her first attempt. The EE (%) in the 8 direction will be measured. The smaller EE indicated poorer balance performance.
1 month follow-up (14 week)
Limit of Stability (LOS)-Maximum Excursion
Time Frame: Baseline (0 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Maximum excursion (ME) is used to assess the maximum amount the patient leaned during the trial. The ME (%) in the 8 direction will be measured. The smaller ME indicated poorer balance performance.
Baseline (0 week)
Limit of Stability (LOS)-Maximum Excursion
Time Frame: Mid-intervention (5 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Maximum excursion (ME) is used to assess the maximum amount the patient leaned during the trial. The ME (%) in the 8 direction will be measured. The smaller ME indicated poorer balance performance.
Mid-intervention (5 week)
Limit of Stability (LOS)-Maximum Excursion
Time Frame: Post-intervention (10 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Maximum excursion (ME) is used to assess the maximum amount the patient leaned during the trial. The ME (%) in the 8 direction will be measured. The smaller ME indicated poorer balance performance.
Post-intervention (10 week)
Limit of Stability (LOS)-Maximum Excursion
Time Frame: 1 month follow-up (14 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Maximum excursion (ME) is used to assess the maximum amount the patient leaned during the trial. The ME (%) in the 8 direction will be measured. The smaller ME indicated poorer balance performance.
1 month follow-up (14 week)
Limit of Stability (LOS)-Directional Control
Time Frame: Baseline (0 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Directional control (DC) is used to assess how much of the patient's movement was in the target direction. The DC (%) in the 8 direction will be measured. The smaller DC indicated poorer balance performance.
Baseline (0 week)
Limit of Stability (LOS)-Directional Control
Time Frame: Mid-intervention (5 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Directional control (DC) is used to assess how much of the patient's movement was in the target direction. The DC (%) in the 8 direction will be measured. The smaller DC indicated poorer balance performance.
Mid-intervention (5 week)
Limit of Stability (LOS)-Directional Control
Time Frame: Post-intervention (10 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Directional control (DC) is used to assess how much of the patient's movement was in the target direction. The DC (%) in the 8 direction will be measured. The smaller DC indicated poorer balance performance.
Post-intervention (10 week)
Limit of Stability (LOS)-Directional Control
Time Frame: 1 month follow-up (14 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Directional control (DC) is used to assess how much of the patient's movement was in the target direction. The DC (%) in the 8 direction will be measured. The smaller DC indicated poorer balance performance.
1 month follow-up (14 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Shamay NG, PhD, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2022

Primary Completion (Actual)

March 23, 2023

Study Completion (Actual)

March 23, 2023

Study Registration Dates

First Submitted

May 29, 2022

First Submitted That Met QC Criteria

June 3, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022_TVNS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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