Comparing Unimanual and Bimanual Mirror Therapy for Upper Limb Recovery Post Stroke

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT02780440

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

22 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Home Mirror Therapy: A Randomized Control Study Comparing Unimanual and Bimanual Mirror Therapy for Improved Hand Function Post-stroke

Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Control Group 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.

Arm

Intervention/Treatment

Control Group

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.

Outcome Measures

Primary Outcome Measures

Fugl-Meyer Assessment (FMA) [Baseline to Six (6) Weeks]
Gold Standard to evaluate and measure recovery in patients with hemiplegia post stroke.
Grip strength [Baseline to Six (6) Weeks]
Grip strength is important to measure as it is correlated with stroke recovery.
Action Research Arm Test (ARAT) [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 [Baseline to Six (6) Weeks]
A subjective standardized 59-items 8 domain questionnaire assessing health status post-stroke.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

First time unilateral stroke > 3 months post stroke.
Cognitively be able to follow direction
Cognitively be able to consent to participation in research study
Moderate/severe deficits as per the Fugl-Meyer assessment score from 10-50 and the ability to grasp and release a small towel or washcloth.

Exclusion Criteria:

Complex medical problems, that would render the subject unable to participate in an extensive home program
History of pre-existing neurological or psychiatric diseases, orthopedic conditions of the upper limbs, or peripheral nerve injuries that render the subject unable to sit or to move either upper limb
Hearing and vision impairments which may impede subjects participation in the home program
Perceptual deficits such as apraxia, neglect, or agnosias as per clinical evaluation which may impede subjects participation in the home program
Botox injection in affected arm/hand within 3 months
Global aphasia that may interfere with understanding instruction for testing or home exercise program.