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Action Selection and Arm Rehabilitation After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arm Training with Action Selection
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Upper Extremity, Physical Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Training with Action Selection

Arm Description

Task-oriented, functional arm training with the addition of action selection cues to practice. All participants receive the same arm training intervention.

Outcomes

Primary Outcome Measures

Action Research Arm Test
Behavioral assessment of arm function. Scores range from 0 to 57 with a higher score equating to better function.
Brain activation during functional MRI
Brain activation during movement will be captured with functional MRI. Analyses will investigate changes in magnitude of activation.
Brain connectivity during functional MRI
Brain activation during movement will be captured with functional MRI. Analyses will investigate changes in connectivity between brain regions.

Secondary Outcome Measures

Upper Extremity Fugl-Meyer Motor Assessment
Stroke Impact Scale Hand Domain
Box & Blocks Test
9-Hole Peg Test
Grip Strength
Confidence in Arm and Hand Movements Questionnaire

Full Information

First Posted
May 9, 2016
Last Updated
July 16, 2021
Sponsor
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02785419
Brief Title
Action Selection and Arm Rehabilitation After Stroke
Official Title
Targeted Engagement of the Motor Action Selection Network During Arm Rehabilitation After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 8, 2015 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rehabilitation, Upper Extremity, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm Training with Action Selection
Arm Type
Experimental
Arm Description
Task-oriented, functional arm training with the addition of action selection cues to practice. All participants receive the same arm training intervention.
Intervention Type
Behavioral
Intervention Name(s)
Arm Training with Action Selection
Other Intervention Name(s)
Functional task practice, Arm rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Action Research Arm Test
Description
Behavioral assessment of arm function. Scores range from 0 to 57 with a higher score equating to better function.
Time Frame
Change from baseline to end of treatment (3 weeks)
Title
Brain activation during functional MRI
Description
Brain activation during movement will be captured with functional MRI. Analyses will investigate changes in magnitude of activation.
Time Frame
Change from baseline to end of treatment (3 weeks)
Title
Brain connectivity during functional MRI
Description
Brain activation during movement will be captured with functional MRI. Analyses will investigate changes in connectivity between brain regions.
Time Frame
Change from baseline to end of treatment (3 weeks)
Secondary Outcome Measure Information:
Title
Upper Extremity Fugl-Meyer Motor Assessment
Time Frame
Change from baseline to end of treatment (3 weeks)
Title
Stroke Impact Scale Hand Domain
Time Frame
Change from baseline to end of treatment (3 weeks)
Title
Box & Blocks Test
Time Frame
Change from baseline to end of treatment (3 weeks)
Title
9-Hole Peg Test
Time Frame
Change from baseline to end of treatment (3 weeks)
Title
Grip Strength
Time Frame
Change from baseline to end of treatment (3 weeks)
Title
Confidence in Arm and Hand Movements Questionnaire
Time Frame
Change from baseline to end of treatment (3 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

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Action Selection and Arm Rehabilitation After Stroke

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