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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02780440
First Posted: May 23, 2016
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose

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.

Condition Intervention
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
Study Design: 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

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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.


Enrollment: 22
Study Start Date: November 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Steve Vanlew, MD New York University Medical School
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02780440     History of Changes
Other Study ID Numbers: 14-01859
First Submitted: May 19, 2016
First Posted: May 23, 2016
Last Update Posted: November 6, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
Post Stroke Recovery
Mirror Therapy
Unimanual mirror therapy
Bimanual mirror therapy
Stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases