- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02785419
Action Selection and Arm Rehabilitation After Stroke
July 16, 2021 updated by: Jill Stewart, PT, PhD, University of South Carolina
Targeted Engagement of the Motor Action Selection Network During Arm Rehabilitation After Stroke
After stroke, individuals often have persistent difficulty using the arm and hand in everyday functional tasks that reduces quality of life.
Currently available rehabilitation techniques are not adequate and new protocols are needed that are based on an understanding of how brain regions work together to produce skilled movement.
This research project aims to improve our understanding of how the brain controls movement after stroke and determine whether a period of motor practice that targets specific brain regions through the addition of action selection demands leads to improved arm function.
We hypothesize that arm motor function and the ability to efficiently activate the action selection motor circuit during movement will improve after training.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Rehabilitation of arm impairment after stroke includes the repetitive practice of functional tasks.
In healthy adults, planning plays a vital role in the control of skilled movement, however, the behavioral and neural correlates of planning have largely been unexplored in individuals recovering from stroke.
Action selection is an important motor planning process that engages dorsal premotor cortex (PMd) in controls.
While PMd activation is a commonly reported neural correlate of motor recovery after stroke, the role of PMd in action selection and motor training are not known.
Therefore, the purpose of this study is to determine the effect of training that includes action selection demands on the behavioral and neural correlates of movement after stroke.
Thirty-eight individuals in the chronic phase of stroke will be recruited.
After completion of clinical measures of impairment and function, all participants with stroke will complete a motor action selection task and functional MRI followed by arm training.
Arm training will consist of three weeks (15 sessions) of arm motor training (1.5 hours per session) that includes action selection demands on movement.
Follow-up clinical testing will occur at the end of treatment and three weeks later.
Study Type
Interventional
Enrollment (Actual)
32
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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South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At least 18 years old
- Had stroke at least 6 months ago
- Right-hand dominant prior to stroke
- Some continued arm and hand weakness
- Some ability to move the arm and hand that is weaker from the stroke
Exclusion Criteria:
- Acute medical issues that would interfere with participation
- Another neurologic diagnosis that may impact movement (e.g. Parkinson's Disease)
- Cannot undergo MRI scanning
- Severe apraxia or hemispatial neglect
- Pain in the arm that interferes with movement
- Difficulty maintaining attention or following directions
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm Training with Action Selection
Task-oriented, functional arm training with the addition of action selection cues to practice.
All participants receive the same arm training intervention.
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Treatment occurs in 1.5 hour sessions, 5 times a week for 3 weeks.
In each treatment session, you will practice functional tasks with your weaker arm and hand.
Additionally, you will be given cues on a computer screen that dictate your movement response (action selection).
Practice will be scaled to match your current level of function and progressed over time as able.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Action Research Arm Test
Time Frame: Change from baseline to end of treatment (3 weeks)
|
Behavioral assessment of arm function.
Scores range from 0 to 57 with a higher score equating to better function.
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Change from baseline to end of treatment (3 weeks)
|
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Brain activation during functional MRI
Time Frame: Change from baseline to end of treatment (3 weeks)
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Brain activation during movement will be captured with functional MRI.
Analyses will investigate changes in magnitude of activation.
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Change from baseline to end of treatment (3 weeks)
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Brain connectivity during functional MRI
Time Frame: Change from baseline to end of treatment (3 weeks)
|
Brain activation during movement will be captured with functional MRI.
Analyses will investigate changes in connectivity between brain regions.
|
Change from baseline to end of treatment (3 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Upper Extremity Fugl-Meyer Motor Assessment
Time Frame: Change from baseline to end of treatment (3 weeks)
|
Change from baseline to end of treatment (3 weeks)
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Stroke Impact Scale Hand Domain
Time Frame: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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Box & Blocks Test
Time Frame: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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9-Hole Peg Test
Time Frame: Change from baseline to end of treatment (3 weeks)
|
Change from baseline to end of treatment (3 weeks)
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Grip Strength
Time Frame: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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Confidence in Arm and Hand Movements Questionnaire
Time Frame: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 8, 2015
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
May 9, 2016
First Submitted That Met QC Criteria
May 24, 2016
First Posted (Estimate)
May 27, 2016
Study Record Updates
Last Update Posted (Actual)
July 23, 2021
Last Update Submitted That Met QC Criteria
July 16, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00032516
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.