- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04668573
Turning Dysfunction After Stroke: Assessment and Intervention
December 13, 2020 updated by: Pei Jung Liang, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Turning Dysfunction After Stroke And Its Association To Trunk Control: Underlying Mechanisms And Training Effects
The study aims to investigate the 1) differences between stroke patients and healthy controls in time, steps, angular velocity, stepping patterns, electromyographic responses during turning, and the association of turning to trunk control and motor function after stroke; 2) the effectiveness of trunk training on turning performance, trunk control and motor function in stroke patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study has two parts.
The first part is a cross-sectional observatory study.Eligible stroke and healthy subjects are asked their demographic data and assessed for turning performance (stepping patterns and electromyography data of trunk muscles), trunk control (muscle strength, active range of motion, muscle mass and motor control in trunk) and motor function (recovery of extremities and balance function).
The second part is a randomized controlled trial.
Stroke participants are randomly allocated into trunk exercise and control groups.
Trunk exercise group receives trunk exercise including trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks while control group remains their regular activities.
Turning performance, trunk control and motor function are evaluated before and after training session.
Study Type
Interventional
Enrollment (Actual)
42
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
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New Taipei City, Taiwan
- Taipei Tzu Chi Hospital
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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
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age between 20 and 80 years old
- survivors of a single and unilateral stroke with hemiparesis experienced at least 6 months prior to their participation in the study
- able to walk independently over a distance of 10 m without walking aids or orthoses
- able to provide informed consent and follow instructions.
Exclusion Criteria:
- having additional musculoskeletal conditions or comorbid disabilities that could affect the assessment
- having cognitive problems with a Mini-Mental State Examination score less than 24 or aphasia that could prevent subjects from following instructions.
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: Trunk exercise group
Participants received trunk exercise for 30 minutes per session, twice a week for 12 weeks.
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Trunk exercise includes trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks.
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No Intervention: Control group
Participants remained their regular activities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in turning duration at Week 12
Time Frame: Baseline and Week 12
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Turning duration (s) was recorded during turning 360-degree in place using APDM Opal wireless sensors.
Longer duration represents poorer turning performance.
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Baseline and Week 12
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Change from Baseline in turning angular velocity at Week 12
Time Frame: Baseline and Week 12
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Angular velocity (m/s2) was recorded during turning 360-degree in place using APDM Opal wireless sensors.
Slower angular velocity represents instability during turning.
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Baseline and Week 12
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Change from Baseline in trunk muscles electromyography during turning at Week 12
Time Frame: Baseline and Week 12
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Muscle activation patterns (amplitude, % reference voluntary contraction) are observed in bilateral External abdominal oblique (EO) and erector spinae (ES) through an electromyographic analysis.
Greater muscle amplitude represents greater muscle contraction.
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Baseline and Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in trunk range of motion at Week 12
Time Frame: Baseline and Week 12
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The trunk range of motion (ROM) was measured using a tape measure in sitting position.
The spinous processes at C7 and S1 served as landmarks for placement of the tape and measurement for trunk flexion and extension ROM.
The length between iliac crest and contralateral acromion of scapula was measured for trunk rotation ROM while the distance between the tip of the middle finger and the floor for trunk lateral flexion ROM.
The difference between tape measures in starting and ending positions was calculated for all trunk movement directions.
Greater value of trunk flexion and rotation but smaller value of trunk extension and lateral flexion represents better trunk ROM.
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Baseline and Week 12
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Change from Baseline in trunk muscles strength at Week 12
Time Frame: Baseline and Week 12
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Trunk flexors, extensors, rotators, and lateral flexors strength were measured using a MicroFET3 dynamometer.
Participants were asked to generate the maximum trunk flexion, extension, rotation bilaterally and lateral flexion bilaterally for a period of 6 seconds each.
Resistance was applied using the dynamometer to obtain the value of each trunk muscle (kg).
Greater value represents greater muscle strength.
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Baseline and Week 12
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Change from Baseline in Trunk Impairment Scale at Week 12
Time Frame: Baseline and Week 12
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Trunk control was assessed by the Trunk Impairment Scale (TIS) which has good inter-rater reliability with intra-class coefficient 0.85-0.99 and internal consistency with Cronbach's α 0.65-0.89.
The TIS evaluates static and dynamic sitting balance and trunk coordination in a sitting position.
On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points.
The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.
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Baseline and Week 12
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Modified Clinical Test of Sensory Integration and Balance at Week 12
Time Frame: Baseline and Week 12
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Modified Clinical Test of Sensory Integration and Balance (mCTSIB) is designed to assess how well an older adult is using sensory inputs when one or more sensory systems are compromised.
The postural sway was measured in 4 sensory conditions through visual and proprioceptive manipulation using APDM Opal wireless sensors.
The greater postural sway represents the poorer balance.
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Baseline and Week 12
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Change from Baseline in Berg Balance Scale at Week 12
Time Frame: Baseline and Week 12
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The Berg balance scale (BBS) is used to objectively determine a participant's ability to safely balance during a series of predetermined tasks.
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
The total score is 56.
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Baseline and Week 12
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Change from Baseline in Timed Up and Go test at Week 12
Time Frame: Baseline and Week 12
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Function mobility was assessed by the Timed Up and Go (TUG) test.
Participants were instructed to stand up from a chair, walk 3 meters, turn around, and walk back to the chair sit down.
Time to complete the task was recorded.
The more time taken is representative of the lower level of functional mobility.
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Baseline and Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Pei-Jung Liang, Taichung Tzu Chi Hospital
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)
July 13, 2020
Primary Completion (Actual)
October 31, 2020
Study Completion (Actual)
October 31, 2020
Study Registration Dates
First Submitted
December 8, 2020
First Submitted That Met QC Criteria
December 13, 2020
First Posted (Actual)
December 16, 2020
Study Record Updates
Last Update Posted (Actual)
December 16, 2020
Last Update Submitted That Met QC Criteria
December 13, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-XD-051
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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