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Study of Hand Therapy 3 to 24 Months After Stroke

NCT ID: NCT00435617

Last Updated: 2012-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2010-05-31

Brief Summary

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The primary aim of this study is to investigate the effectiveness of the use of a robotic hand therapy device in the home environment. We hypothesize that the therapy group will improve hand function more than a customary and usual care group.

Detailed Description

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Many stroke survivors have significant limitations of upper extremity function which impacts many important activities such as eating, dressing and personal care. Studies show that to be effective in increasing functional independence, therapy must involve active participation of the patient and repetitive training. Robotic therapy offers a means of transferring some of this essential, but time consuming, therapy into the home. Seventy subjects (3 to 12 months post stroke)are being randomized to a control group that utilizes an innovative robotic hand therapy device in the home for three months or a control group that receives no device treatment. Clinical motor function and quality of life measures will compare the groups before intervention, immediately after, and 3 months later. The control group will receive device treatment for 3 months following their final evaluation. The results will provide valuable data on the ability of monitored home therapy to provide effective treatment. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.

Conditions

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Cerebrovascular Accident

Keywords

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stroke rehabilitation stroke therapy hand therapy stroke cerebrovascular stroke cerebral stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

Hand Mentor

Group Type EXPERIMENTAL

Hand Mentor

Intervention Type DEVICE

Use of the Hand Mentor therapy device at home for 6 weeks. Therapy programs include spasticity reduction, motor control, and emg biofeedback for encouraging activity.

Interventions

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Hand Mentor

Use of the Hand Mentor therapy device at home for 6 weeks. Therapy programs include spasticity reduction, motor control, and emg biofeedback for encouraging activity.

Intervention Type DEVICE

Other Intervention Names

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Hand Mentor Home

Eligibility Criteria

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Inclusion Criteria

* 3 to 24 months post stroke
* Able to extend wrist and fingers at least 10 degrees
* Functional hearing and vision
* Able to follow instructions
* Lives at home, not institution
* Stable medications for 3 months

Exclusion Criteria

* Excessive cognitive impairments
* Taking/Receiving medicines/shots to make arm/hand less stiff
* Severe pain in the impaired arm
* Stroke was more than 24 months ago
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Kinetic Muscles

INDUSTRY

Sponsor Role lead

Responsible Party

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James Koeneman

Chief Science Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James B Koeneman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kinetic Muscles, Inc.

Steven L Wolf, Ph.D., PT

Role: STUDY_DIRECTOR

Emory University Medical School

Richard Herman, MD

Role: STUDY_DIRECTOR

Banner Good Samaritan Medical Center

Locations

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Arizona State University, College of Nursing & Healthcare Innovation

Phoenix, Arizona, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Frick EM, Alberts JL. Combined use of repetitive task practice and an assistive robotic device in a patient with subacute stroke. Phys Ther. 2006 Oct;86(10):1378-86. doi: 10.2522/ptj.20050149.

Reference Type BACKGROUND
PMID: 17012642 (View on PubMed)

Related Links

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http://www.kineticmuscles.com

Company web site

Other Identifiers

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R44HD041805

Identifier Type: NIH

Identifier Source: secondary_id

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R44HD041805

Identifier Type: NIH

Identifier Source: org_study_id

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