Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiparesis
• Intervention / Treatment: Behavioral: Mirror therapy; Behavioral: Divider therapy

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Elkins Park, Pennsylvania, United States, 19027
      • Einstein Medical Center Elkins Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mirror therapy; 4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.	Behavioral: Mirror therapy; A home-based therapy involving mirrored visual feedback
Active Comparator: 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.	Behavioral: Divider therapy; A home-based therapy involving removed visual feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Extremity Fugl-Meyer	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.	Immediately after 1 month of treatment
Action Research Arm Test	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.	1 month
Rivermead Assessment of Somatosensory Performance	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.	1 month
Virtual-reality Assessment of Navigation	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Impact Scale	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.	1 month
Wolf Motor Function Test	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.	1 months

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network
• Investigators: Principal Investigator: Steven Jax, Ph. D., Albert Einstein Healthcare Network

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2012
• Primary Completion (Actual): February 27, 2017
• Study Completion (Actual): February 27, 2017

Study Registration Dates

• First Submitted: August 8, 2012
• First Submitted That Met QC Criteria: August 9, 2012
• First Posted (Estimate): August 13, 2012

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: stroke; hemiparesis; arm movement; sensory functioning
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: HN 4404; NIH R01 HD068565 (Other Identifier: Einstein Healthcare Network)