A Feasible Smart Upper Limb Rehabilitation Model for Patients With Stroke and Spinal Cord Injuries

January 10, 2024 updated by: National Cheng-Kung University Hospital

Establishment of a Feasible Smart Upper Limb Rehabilitation Model in Post-pandemic Era: Examples for Patients With Stroke and Spinal Cord Injuries

The goal of this clinical trial is to investigate the effectiveness of the developed application and exoskeleton robot devices for home-based training in stroke patients and patients with spinal cord injuries. The application that uses an Internet of Things (IoT) platform to enable remote monitoring of rehabilitation progress by clinical practitioners. Simultaneously, it seeks to assist the execution of patient movements through devices.

In patients with stroke, half of the participants will be assigned to experimental group, receiving a smart upper limb motor rehabilitation system for home program. The other half will be assigned to control group, receiving a traditional home program. In patients with spinal cord injuries. Participants will follow the same allocation method for home-based intervention.

Researchers will conduct an analysis before and after intervention, examining progress in motor function, activities of daily living, and quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng-Kung University Hospital
        • Contact:
      • Tainan, Taiwan, 710
        • Recruiting
        • Chi Mei Medical Center
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: For patients with stroke

  • 20-79 years old.
  • The score of Montreal Cognitive Assessment is more than or equal to 26.
  • The unilateral hemorrhagic or ischemic participants.
  • The performance of upper limb movement is affected by damage to brain cells.

Inclusion Criteria: For patients with spinal cord injury

  • 20-65 years old.
  • The score of Mini-Mental Status Examination is more than or equal to 25.
  • Diagnosed as incomplete spinal cord injury at the C5 or C6 level.

Exclusion Criteria: For patients with stroke

  • Underwent sugery on the shoulder, elbow or wrist.
  • Severe pain in upper limb.
  • Another muscular or neurological diseases that effects motor performance.

Exclusion Criteria: For patients with spinal cord injury

  • Underwent sugery on the shoulder, elbow or wrist.
  • Severe pain in upper limb.
  • Another muscular or neurological diseases that effects motor performance.

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: Stroke: TIGER group
Participants in the TIGER (tenodesis-induced-grip exoskeleton robot) group will operate the TIGER system. They will undergo a 30-minute home-based training program twice a day, 5 days a week for 4 weeks.
Other: Robot-assisted therapy
The TIGER system provides assistance for activities of daily living. Continuous passive mode of TIGER system provides passive range of motion as warm-up. Functional mode TIGER system provides functional training.
Active Comparator: Stroke: TOT group
Participants in the TOT (task-oriented training) group will receive task-oriented training as home program. They will undergo a 30-minute home-based training program twice a day, 5 days a week for 4 weeks.
Other: Task-oriented training
The TOT group will practice sensorimotor techniques for warming up, and then they will practice various functional tasks based on task-oriented approach.
Experimental: Spinal cord injury: TIGER group
Participants in the TIGER (tenodesis-induced-grip exoskeleton robot) group will operate the TIGER system. They will undergo a 40-minute home-based training program once a day, 5 days a week for 4 weeks.
Other: Robot-assisted therapy
The TIGER system provides assistance for activities of daily living. Continuous passive mode of TIGER system provides passive range of motion as warm-up. Functional mode TIGER system provides functional training.
Active Comparator: Spinal cord injury: TOT group
Participants in the TOT (task-oriented training) group will receive task-oriented training as home program. They will undergo a 40-minute home-based training program once a day, 5 days a week for 4 weeks.
Other: Task-oriented training
The TOT group will practice sensorimotor techniques for warming up, and then they will practice various functional tasks based on task-oriented approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment - Upper Extremity -Stroke Group - Baseline
Time Frame: Baseline, 4 weeks after baseline
Fugl-Meyer Assessment - Upper Extremity is an assessment for the progress in the impairment of upper limb. 33 items in the FMA-UE include reflex activity, voluntary movement, and coordination of upper limb. 0 means movement cannot be performed, 1 means movement is partially performed and 2 means entirely performed. The minimal score is 0. The maximal score is 66. The minimal detectable change is considered 5.2.
Baseline, 4 weeks after baseline
Fugl-Meyer Assessment - Upper Extremity -Stroke Group - 4 weeks after baseline
Time Frame: Baseline, 4 weeks after baseline
Fugl-Meyer Assessment - Upper Extremity is an assessment for the progress in the impairment of upper limb. 33 items in the FMA-UE include reflex activity, voluntary movement, and coordination of upper limb. 0 means movement cannot be performed, 1 means movement is partially performed and 2 means entirely performed. The minimal score is 0. The maximal score is 66. The minimal detectable change is considered 5.2.
Baseline, 4 weeks after baseline
Motor Activity Log -Stroke Group - Baseline
Time Frame: Baseline, 4 weeks after baseline
Motor Activity Log is a semi-structured interview to understand functional performance in individual's home. The 30 questions ask patients about perceived difficulty in daily activities, including the amount of use of their affected arm and the quality of movement. The higher scores in the former mean the higher amount of patient using his weaker arm compared to before the stroke onset. The higher scores in the latter mean the higher movement quality during daily activities. The assessment is with a range of 0 to 5. Patients can give half scores if it is more reflective for their ratings. Adding all ratings, scores will take the average. The minimal score is 0. The maximal score is 5. The minimal detectable change value is considered 1.0-1.1.
Baseline, 4 weeks after baseline
Motor Activity Log -Stroke Group - 4 weeks after baseline
Time Frame: Baseline, 4 weeks after baseline
Motor Activity Log is a semi-structured interview to understand functional performance in individual's home. The 30 questions ask patients about perceived difficulty in daily activities, including the amount of use of their affected arm and the quality of movement. The higher scores in the former mean the higher amount of patient using his weaker arm compared to before the stroke onset. The higher scores in the latter mean the higher movement quality during daily activities. The assessment is with a range of 0 to 5. Patients can give half scores if it is more reflective for their ratings. Adding all ratings, scores will take the average. The minimal score is 0. The maximal score is 5. The minimal detectable change value is considered 1.0-1.1.
Baseline, 4 weeks after baseline
Range of Motion -Stroke Group - Baseline
Time Frame: Baseline, 4 weeks after baseline
Range of Motion is an assessment to evaluate the movements in forearm and wrist joints with a goniometer.
Baseline, 4 weeks after baseline
Range of Motion -Stroke Group - 4 weeks after baseline
Time Frame: Baseline, 4 weeks after baseline
Range of Motion is an assessment to evaluate the movements in forearm and wrist joints with a goniometer.
Baseline, 4 weeks after baseline
Box and Block Test -Stroke Group - Baseline
Time Frame: Baseline, 4 weeks after baseline
Box and Block Test is an assessment for hand dexterity. It starts with unaffected hand and involves moving blocks one by one from a box to another one within 60 seconds. The score for each hand is calculated separately. The more blocks the patient moves in 1 minute, the better hand dexterity. The minimal detectable change value is determined for improvement in performance with 5.5 blocks or increase in 18 percent.
Baseline, 4 weeks after baseline
Box and Block Test -Stroke Group - 4 weeks after baseline
Time Frame: Baseline, 4 weeks after baseline
Box and Block Test is an assessment for hand dexterity. It starts with unaffected hand and involves moving blocks one by one from a box to another one within 60 seconds. The score for each hand is calculated separately. The more blocks the patient moves in 1 minute, the better hand dexterity. The minimal detectable change value is determined for improvement in performance with 5.5 blocks or increase in 18 percent.
Baseline, 4 weeks after baseline
Modified Tardieu Scale -Stroke Group - Baseline
Time Frame: Baseline, 4 weeks after baseline
Modifed Tardieu Scale is an assessment for the level of spasticity at wrist joint. According to the difficulty during passive joint stretching, the score ranges from 0 to 4 in an ordinal scale. 0 means no increase in muscle tone and 4 represents unfatigable clonus occurring at a precise angle. The angle of muscle reaction is measured with a goniometer to determine where spasticity occurs during passive stretching.
Baseline, 4 weeks after baseline
Modified Tardieu Scale -Stroke Group - 4 weeks after baseline
Time Frame: Baseline, 4 weeks after baseline
Modifed Tardieu Scale is an assessment for the level of spasticity at wrist joint. According to the difficulty during passive joint stretching, the score ranges from 0 to 4 in an ordinal scale. 0 means no increase in muscle tone and 4 represents unfatigable clonus occurring at a precise angle. The angle of muscle reaction is measured with a goniometer to determine where spasticity occurs during passive stretching.
Baseline, 4 weeks after baseline
Semmes-Weinstein monofilament test -Stroke Group - Baseline
Time Frame: Baseline, 4 weeks after baseline
Semmes-Weinstein monofilament test is an assessment for touch pressure threshold of hand. The evaluator uses nylon monofilaments of different diameters, exerting a constant force on skin for 1-1.5 seconds. The score is recorded as the finest filament that the participant could detect in at least 1 of the 3 trials. The thicker filament represents the higher score, indicating worse sensibility of hand.
Baseline, 4 weeks after baseline
Semmes-Weinstein monofilament test -Stroke Group - 4 weeks after baseline
Time Frame: Baseline, 4 weeks after baseline
Semmes-Weinstein monofilament test is an assessment for touch pressure threshold of hand. The evaluator uses nylon monofilaments of different diameters, exerting a constant force on skin for 1-1.5 seconds. The score is recorded as the finest filament that the participant could detect in at least 1 of the 3 trials. The thicker filament represents the higher score, indicating worse sensibility of hand.
Baseline, 4 weeks after baseline
System Usability Scale -Stroke Group - 4 weeks after baseline
Time Frame: 4 weeks after baseline
System Usability Scale is a questionnaire for assessing effectiveness and satisfaction from user's subjective perspective. It consists of 10 items with a 5-point ordinal scale. 1 means strongly disagree and 5 means strongly agree. Score ranges from 0 to 100%. The threshold of good usability is 68%.
4 weeks after baseline
Manual Muscle Testing -Spinal Cord Injury Group - Baseline
Time Frame: Baseline, 4 weeks after baseline
Manual Muscle Testing is an assessment for muscle strength in forearm and wrist muscles. It ranges from 0 to 5 in an ordinal scale. 0 means no contraction palpable and 5 means normal muscle strength.
Baseline, 4 weeks after baseline
Manual Muscle Testing -Spinal Cord Injury Group - 4 weeks after baseline
Time Frame: Baseline, 4 weeks after baseline
Manual Muscle Testing is an assessment for muscle strength in forearm and wrist muscles. It ranges from 0 to 5 in an ordinal scale. 0 means no contraction palpable and 5 means normal muscle strength.
Baseline, 4 weeks after baseline
Range of Motion -Spinal Cord Injury Group - Baseline
Time Frame: Baseline, 4 weeks after baseline
Range of Motion is an assessment to evaluate the movements in forearm and wrist joints with a goniometer.
Baseline, 4 weeks after baseline
Range of Motion -Spinal Cord Injury Group - 4 weeks after baseline
Time Frame: Baseline, 4 weeks after baseline
Range of Motion is an assessment to evaluate the movements in forearm and wrist joints with a goniometer.
Baseline, 4 weeks after baseline
Functional Independence Measure -Spinal Cord Injury Group - Baseline
Time Frame: Baseline, 4 weeks after baseline
Functional Independence Measure is an assessment for the functional independence status of an individual. It consists of 18 items with a 7-point ordinal scale. 1 means requiring total assistance and 7 means completely independent.
Baseline, 4 weeks after baseline
Functional Independence Measure -Spinal Cord Injury Group - 4 weeks after baseline
Time Frame: Baseline, 4 weeks after baseline
Functional Independence Measure is an assessment for the functional independence status of an individual. It consists of 18 items with a 7-point ordinal scale. 1 means requiring total assistance and 7 means completely independent.
Baseline, 4 weeks after baseline
Box and Block Test -Spinal Cord Injury Group - Baseline
Time Frame: Baseline, 4 weeks after baseline
Box and Block Test is an assessment for hand dexterity. It starts with unaffected hand and involves moving blocks one by one from a box to another one within 60 seconds. The score for each hand is calculated separately. The more blocks the patient moves in 1 minute, the better hand dexterity. The minimal detectable change value is determined for improvement in performance with 5.5 blocks or increase in 18 percent.
Baseline, 4 weeks after baseline
Box and Block Test -Spinal Cord Injury Group - 4 weeks after baseline
Time Frame: Baseline, 4 weeks after baseline
Box and Block Test is an assessment for hand dexterity. It starts with unaffected hand and involves moving blocks one by one from a box to another one within 60 seconds. The score for each hand is calculated separately. The more blocks the patient moves in 1 minute, the better hand dexterity. The minimal detectable change value is determined for improvement in performance with 5.5 blocks or increase in 18 percent.
Baseline, 4 weeks after baseline
WHO Quality of Life-BREF -Spinal Cord Injury Group - Baseline
Time Frame: Baseline, 4 weeks after baseline
WHO Quality of Life-BREF is a questionnaire for assessing subjective outcome of quality of life. It consists of 26 items with a 5-point ordinal scale. 1 means very dissatisfied and 5 means very satisfied. The scores are transformed linearly to a 0-100.
Baseline, 4 weeks after baseline
WHO Quality of Life-BREF -Spinal Cord Injury Group - 4 weeks after baseline
Time Frame: Baseline, 4 weeks after baseline
WHO Quality of Life-BREF is a questionnaire for assessing subjective outcome of quality of life. It consists of 26 items with a 5-point ordinal scale. 1 means very dissatisfied and 5 means very satisfied. The scores are transformed linearly to a 0-100.
Baseline, 4 weeks after baseline
Taiwanese Version of Quebec User Evaluation of Satisfaction with Assistive Technology -Spinal Cord Injury Group - 4 weeks after baseline
Time Frame: 4 weeks after baseline
Taiwanese Version of Quebec User Evaluation of Satisfaction with Assistive Technology (T-QUEST) is a questionnaire for assessing user satisfaction with the use of assistive device. It consists of 12 items with a 5-point ordinal scale. 1 means not satisfied at all and 5 means very satisfied. The assessment has a range of 0 to 5.
4 weeks after baseline

Collaborators and Investigators

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

Sponsor

National Cheng-Kung University Hospital

Investigators

  • Principal Investigator: Li-Chieh Kuo, Ph.D, National Cheng Kung University

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 (Estimated)

January 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ER-110-563

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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