Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke

NCT ID: NCT01662960

Last Updated: 2020-06-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-07

Study Completion Date

2017-02-27

Brief Summary

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The purpose of the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home.

Detailed Description

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This study will compare two forms of home-based treatment for post-stroke problems making movements with the arms and hands. After initial pre-treatment assessments, participants will complete 4 weeks of treatment, with assessments after each week of treatment and 3 months after the completion of treatment.

Conditions

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Hemiparesis Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Mirror therapy

4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.

Group Type EXPERIMENTAL

Mirror therapy

Intervention Type BEHAVIORAL

A home-based therapy involving mirrored visual feedback

Divider therapy

4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.

Group Type ACTIVE_COMPARATOR

Divider therapy

Intervention Type BEHAVIORAL

A home-based therapy involving removed visual feedback.

Interventions

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Mirror therapy

A home-based therapy involving mirrored visual feedback

Intervention Type BEHAVIORAL

Divider therapy

A home-based therapy involving removed visual feedback.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 6 months or more post-stroke
* upper extremity Fugl-Meyer score between 10 and 50
* no longer participating in upper-extremity physical or occupational therapy
* sufficient comprehension ability to understand instructions

Exclusion Criteria

* previous head trauma, psychiatric illness or chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g., haloperidol, dopaminergics)
* dementia
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albert Einstein Healthcare Network

OTHER

Sponsor Role lead

Responsible Party

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Steve Jax

Institute Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven Jax, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein Healthcare Network

Locations

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Einstein Medical Center Elkins Park

Elkins Park, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NIH R01 HD068565

Identifier Type: OTHER

Identifier Source: secondary_id

HN 4404

Identifier Type: -

Identifier Source: org_study_id

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