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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780440
• Other study ID #: 14-01859
• Status: Completed
• Start date: November 2014
• Est. completion date: March 2018

Study information

• Verified date: May 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this randomized controlled study is to

1. Examine the feasibility of a home Mirror therapy (MT) program in the NYC metropolitan area;

2. Evaluate the effectiveness of home MT versus traditional home exercise program; and

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Vascular Accident (CVA)
• Stroke

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment (FMA)	Gold Standard to evaluate and measure recovery in patients with hemiplegia post stroke.	Baseline to Six (6) Weeks
Primary	Grip strength	Grip strength is important to measure as it is correlated with stroke recovery.	Baseline to Six (6) Weeks
Primary	Action Research Arm Test (ARAT)	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.	Baseline to Six (6) Weeks
Primary	Stroke Impact Scale Version 3.0	A subjective standardized 59-items 8 domain questionnaire assessing health status post-stroke.	Baseline to Six (6) Weeks