Action Selection and Arm Rehabilitation After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785419
• Other study ID #: Pro00032516
• Status: Completed
• Phase: N/A
• Start date: December 8, 2015
• Est. completion date: December 2020

Study information

• Verified date: July 2021
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Arm Test	Behavioral assessment of arm function. Scores range from 0 to 57 with a higher score equating to better function.	Change from baseline to end of treatment (3 weeks)
Primary	Brain activation during functional MRI	Brain activation during movement will be captured with functional MRI. Analyses will investigate changes in magnitude of activation.	Change from baseline to end of treatment (3 weeks)
Primary	Brain connectivity during functional MRI	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	Upper Extremity Fugl-Meyer Motor Assessment		Change from baseline to end of treatment (3 weeks)
Secondary	Stroke Impact Scale Hand Domain		Change from baseline to end of treatment (3 weeks)
Secondary	Box & Blocks Test		Change from baseline to end of treatment (3 weeks)
Secondary	9-Hole Peg Test		Change from baseline to end of treatment (3 weeks)
Secondary	Grip Strength		Change from baseline to end of treatment (3 weeks)
Secondary	Confidence in Arm and Hand Movements Questionnaire		Change from baseline to end of treatment (3 weeks)