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Completed

NCT Number: NCT02785419

Action Selection and 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm Training with Action Selection

Behavioral

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

Targeted Engagement of the Motor Action Selection Network During Arm Rehabilitation After Stroke

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
May 27, 2016
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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