Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke

Not Applicable

Completed

• Conditions: Hemiparesis; Stroke
• Interventions: Behavioral: Mirror therapy; Behavioral: Divider therapy

• Registration Number: NCT01662960
• Lead Sponsor: Albert Einstein Healthcare Network

Brief Summary

The purpose of the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home.

Detailed Description

This study will compare two forms of home-based treatment for post-stroke problems making movements with the arms and hands. After initial pre-treatment assessments, participants will complete 4 weeks of treatment, with assessments after each week of treatment and 3 months after the completion of treatment.

Study Timeline

• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-13
• Study Start: 2012-09-07
• Primary Completion: 2017-02-27
• Study Completion: 2017-02-27
• Results First Submitted: 2019-02-12
• Results First Submitted QC: 2019-02-12
• Results First Posted: 2019-05-13
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-19
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 6 months or more post-stroke
• upper extremity Fugl-Meyer score between 10 and 50
• no longer participating in upper-extremity physical or occupational therapy
• sufficient comprehension ability to understand instructions

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Exclusion Criteria

• previous head trauma, psychiatric illness or chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g., haloperidol, dopaminergics)
• dementia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirror therapy	Mirror therapy	4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
Divider therapy	Divider therapy	4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.

Primary Outcome Measures

Name	Time	Method
Upper Extremity Fugl-Meyer	Immediately after 1 month of treatment	This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.
Action Research Arm Test	1 month	The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.
Rivermead Assessment of Somatosensory Performance	1 month	This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.
Virtual-reality Assessment of Navigation	1 month	This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.

Secondary Outcome Measures

Name	Time	Method
Stroke Impact Scale	1 month	This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.
Wolf Motor Function Test	1 months	The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.

Trial Locations

Locations (1)

Einstein Medical Center Elkins Park; 🇺🇸 Elkins Park, Pennsylvania, United States