Comparing Unimanual and Bimanual Mirror Therapy for Upper Limb Recovery Post Stroke
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|ClinicalTrials.gov Identifier: NCT02780440|
Recruitment Status : Active, not recruiting
First Posted : May 23, 2016
Last Update Posted : May 9, 2018
The purpose of this randomized controlled study is to
- Examine the feasibility of a home Mirror therapy (MT) program in the NYC metropolitan area;
- Evaluate the effectiveness of home MT versus traditional home exercise program; and
Evaluate the superiority of unimanual or bimanual MT intervention protocols for chronic stroke subjects with moderate hand deficits. Subjects from occupational therapy at the Ambulatory Care Center of NYU Langone Center with a diagnosis of cerebral vascular accident (CVA) or stroke will be divided into three (3) groups:
- Control Group subjects will participate in standard occupational therapy rehabilitation protocol plus a traditional home based exercise program.
- Experimental group 1 subjects will participate in standard rehabilitation protocol plus unimanual home based mirror therapy program
- Experimental group 2 subjects will participate in standard rehabilitation protocol plus bimanual home based mirror therapy program.
|Condition or disease||Intervention/treatment|
|Cerebral Vascular Accident (CVA) Stroke||Behavioral: Traditional Home Based Exercise Program Behavioral: Unimanual Home Based Mirror Therapy Program Behavioral: Bimanual Home Based Mirror Therapy Program|
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|Official Title:||Home Mirror Therapy: A Randomized Control Study Comparing Unimanual and Bimanual Mirror Therapy for Improved Hand Function Post-stroke|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2019|
Subjects will participate in standard occupational therapy rehabilitation protocol plus a traditional home based exercise program.
Behavioral: Traditional Home Based Exercise Program
Subjects in the control group will receive a traditional home Occupational Training exercise program as per conventional OT guidelines with the same home program duration.
Experimental Group 1
Subjects will participate in standard rehabilitation protocol plus unimanual home based mirror therapy program
Behavioral: Unimanual Home Based Mirror Therapy Program
The affected hand will remain still in the mirror box, the unaffected hand will perform the exercises while the subject watches the mirror reflection.
Experimental Group 2
Subjects will participate in standard rehabilitation protocol plus bimanual home based mirror therapy program.
Behavioral: Bimanual Home Based Mirror Therapy Program
The affected hand in the mirror box will best mimic the unaffected hand, while also watching the mirror reflection.
- Fugl-Meyer Assessment (FMA) [ Time Frame: Baseline to Six (6) Weeks ]Gold Standard to evaluate and measure recovery in patients with hemiplegia post stroke.
- Grip strength [ Time Frame: Baseline to Six (6) Weeks ]Grip strength is important to measure as it is correlated with stroke recovery.
- Action Research Arm Test (ARAT) [ Time Frame: Baseline to Six (6) Weeks ]An interview based tool that measures a subject's perceived difficulty with the use of their arm/hands with activities of daily living post-stroke.
- Stroke Impact Scale Version 3.0 [ Time Frame: Baseline to Six (6) Weeks ]A subjective standardized 59-items 8 domain questionnaire assessing health status post-stroke.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780440
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Steve Vanlew, MD||New York University Medical School|