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Completed

NCT Number: NCT02780440

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

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.

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Key information

Conditions

Cerebral Vascular Accident (CVA) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Home Based Exercise Program

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.

Unimanual Home Based Mirror Therapy Program

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.

Bimanual Home Based Mirror Therapy Program

Behavioral

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

Primary outcomes

  1. Fugl-Meyer Assessment (FMA)

    Time frame: Baseline to Six (6) Weeks

    Gold Standard to evaluate and measure recovery in patients with hemiplegia post stroke.

  2. Grip strength

    Time frame: Baseline to Six (6) Weeks

    Grip strength is important to measure as it is correlated with stroke recovery.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 23, 2016
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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