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Action Selection and Arm Rehabilitation After Stroke

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ClinicalTrials.gov Identifier: NCT02785419
Recruitment Status : Recruiting
First Posted : May 27, 2016
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jill Stewart, PT, PhD, University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Arm Training with Action Selection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Engagement of the Motor Action Selection Network During Arm Rehabilitation After Stroke
Study Start Date : January 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.
Behavioral: Arm Training with Action Selection
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:
  • Functional task practice
  • Arm rehabilitation




Primary Outcome Measures :
  1. 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.

  2. Brain activation 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 magnitude of activation.

  3. 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.


Secondary Outcome Measures :
  1. Upper Extremity Fugl-Meyer Motor Assessment [ Time Frame: Change from baseline to end of treatment (3 weeks) ]
  2. Stroke Impact Scale Hand Domain [ Time Frame: Change from baseline to end of treatment (3 weeks) ]
  3. Box & Blocks Test [ Time Frame: Change from baseline to end of treatment (3 weeks) ]
  4. 9-Hole Peg Test [ Time Frame: Change from baseline to end of treatment (3 weeks) ]
  5. Grip Strength [ Time Frame: Change from baseline to end of treatment (3 weeks) ]
  6. Confidence in Arm and Hand Movements Questionnaire [ Time Frame: Change from baseline to end of treatment (3 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785419


Contacts
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Contact: Jill Stewart, PT, PhD 803-777-9725 jcstewar@mailbox.sc.edu

Locations
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United States, South Carolina
University of South Carolina Recruiting
Columbia, South Carolina, United States, 29208
Contact: Jill Stewart, PT, PhD    803-777-9725    jcstewar@mailbox.sc.edu   
Sponsors and Collaborators
University of South Carolina

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Responsible Party: Jill Stewart, PT, PhD, Assistant Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT02785419     History of Changes
Other Study ID Numbers: Pro00032516
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

Keywords provided by Jill Stewart, PT, PhD, University of South Carolina:
Rehabilitation
Upper Extremity
Physical Therapy

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases