Back to resultsVisual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
Primary Purpose
Hemiparesis, Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mirror therapy
Divider therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparesis focused on measuring stroke, hemiparesis, arm movement, sensory functioning
Eligibility Criteria
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
Sites / Locations
- Einstein Medical Center Elkins Park
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mirror therapy
Divider therapy
Arm Description
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01662960
First Posted
August 8, 2012
Last Updated
June 19, 2020
Sponsor
Albert Einstein Healthcare Network
1. Study Identification
Unique Protocol Identification Number
NCT01662960
Brief Title
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
Official Title
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 7, 2012 (Actual)
Primary Completion Date
February 27, 2017 (Actual)
Study Completion Date
February 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis, Stroke
Keywords
stroke, hemiparesis, arm movement, sensory functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mirror therapy
Arm Type
Experimental
Arm Description
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
Arm Title
Divider therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mirror therapy
Intervention Description
A home-based therapy involving mirrored visual feedback
Intervention Type
Behavioral
Intervention Name(s)
Divider therapy
Intervention Description
A home-based therapy involving removed visual feedback.
Primary Outcome Measure Information:
Title
Upper Extremity Fugl-Meyer
Description
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.
Time Frame
Immediately after 1 month of treatment
Title
Action Research Arm Test
Description
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.
Time Frame
1 month
Title
Rivermead Assessment of Somatosensory Performance
Description
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.
Time Frame
1 month
Title
Virtual-reality Assessment of Navigation
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Stroke Impact Scale
Description
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.
Time Frame
1 month
Title
Wolf Motor Function Test
Description
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.
Time Frame
1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Jax, Ph. D.
Organizational Affiliation
Albert Einstein Healthcare Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Einstein Medical Center Elkins Park
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
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