NCT02780440

Brief Summary

The purpose of this randomized controlled study is to

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

3.3 years

First QC Date

May 19, 2016

Last Update Submit

May 8, 2019

Conditions

Keywords

Post Stroke RecoveryMirror TherapyUnimanual mirror therapyBimanual mirror therapyStroke

Outcome Measures

Primary Outcomes (4)

  • Fugl-Meyer Assessment (FMA)

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

    Baseline to Six (6) Weeks

  • Grip strength

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

    Baseline to Six (6) Weeks

  • 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

  • Stroke Impact Scale Version 3.0

    A subjective standardized 59-items 8 domain questionnaire assessing health status post-stroke.

    Baseline to Six (6) Weeks

Study Arms (3)

Control Group

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

Behavioral: Traditional Home Based Exercise Program

Experimental Group 1

Subjects will participate in standard rehabilitation protocol plus unimanual home based mirror therapy program

Behavioral: Unimanual Home Based Mirror Therapy Program

Experimental Group 2

Subjects will participate in standard rehabilitation protocol plus bimanual home based mirror therapy program.

Behavioral: Bimanual Home Based Mirror Therapy Program

Interventions

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.

Control Group

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 1

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

Experimental Group 2

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Steve Vanlew, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 23, 2016

Study Start

November 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 10, 2019

Record last verified: 2019-05

Locations