NCT02785419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

5 years

First QC Date

May 9, 2016

Last Update Submit

July 16, 2021

Conditions

Keywords

RehabilitationUpper ExtremityPhysical Therapy

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (6)

  • Upper Extremity Fugl-Meyer Motor Assessment

    Change from baseline to end of treatment (3 weeks)

  • Stroke Impact Scale Hand Domain

    Change from baseline to end of treatment (3 weeks)

  • Box & Blocks Test

    Change from baseline to end of treatment (3 weeks)

  • 9-Hole Peg Test

    Change from baseline to end of treatment (3 weeks)

  • Grip Strength

    Change from baseline to end of treatment (3 weeks)

  • +1 more secondary outcomes

Study Arms (1)

Arm Training with Action Selection

EXPERIMENTAL

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

Interventions

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.

Also known as: Functional task practice, Arm rehabilitation
Arm Training with Action Selection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 27, 2016

Study Start

December 8, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

July 23, 2021

Record last verified: 2021-07

Locations