Clinical trial NCT02780440: Comparing Unimanual and Bimanual Mirror Therapy for Upper Limb Recovery Post Stroke
Official title: Home Mirror Therapy: A Randomized Control Study Comparing Unimanual and Bimanual Mirror Therapy for Improved Hand Function Post-stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Vascular Accident (CVA)
Stroke
Keywords: Post Stroke Recovery
Mirror Therapy
Unimanual mirror therapy
Bimanual mirror therapy
Stroke
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 22
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants included in the study will be those referred to outpatient occupational therapy at the Ambulatory Care Center of NYU Langone Center with a diagnosis of cerebral vascular accident (CVA) or stroke.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Baseline to Six (6) Weeks
measure: Grip strength
timeFrame: Baseline to Six (6) Weeks
measure: Action Research Arm Test (ARAT)
timeFrame: Baseline to Six (6) Weeks
measure: Stroke Impact Scale Version 3.0
timeFrame: Baseline to Six (6) Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Steve Vanlew, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.