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

NCT ID: NCT02780440

Last Updated: 2019-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Vascular Accident (CVA) Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group

Subjects will participate in standard occupational therapy rehabilitation protocol plus a traditional home based exercise program.

Traditional Home Based Exercise Program

Intervention Type BEHAVIORAL

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

Unimanual Home Based Mirror Therapy Program

Intervention Type BEHAVIORAL

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.

Bimanual Home Based Mirror Therapy Program

Intervention Type BEHAVIORAL

The affected hand in the mirror box will best mimic the unaffected hand, while also watching the mirror reflection.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve Vanlew, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

References

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Geller D, Nilsen DM, Quinn L, Van Lew S, Bayona C, Gillen G. Home mirror therapy: a randomized controlled pilot study comparing unimanual and bimanual mirror therapy for improved arm and hand function post-stroke. Disabil Rehabil. 2022 Nov;44(22):6766-6774. doi: 10.1080/09638288.2021.1973121. Epub 2021 Sep 19.

Reference Type DERIVED
PMID: 34538193 (View on PubMed)

Other Identifiers

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14-01859

Identifier Type: -

Identifier Source: org_study_id

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