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Rehabilitation of the Stroke Hand at Home

NCT ID: NCT01144715

Last Updated: 2014-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-09-30

Brief Summary

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The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations. The robotic-based home therapy intervention will produce significantly greater improvement in upper extremity motor function than Usual and Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation program at the end of 8 weeks of home therapy.

Detailed Description

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The primary purpose of this proposal is to evaluate a combined clinic/home robotic-based stroke therapy delivery and monitoring system in rural and underserved locations that provides accessible, effective and affordable care for stroke survivors with residual limb impairment. The study is a prospective, single-blind, multi-site Randomized Controlled Trial. A total of 96 patients within 6 months post-stroke will be enrolled and randomly assigned to one of two groups: robotic based home therapy or a self administered (non-robotic) home therapy program.

Conditions

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Stroke

Keywords

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Stroke Rehabilitation Home rehabilitation robotic therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hand Mentor Therapy

Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks

Group Type EXPERIMENTAL

Hand Mentor (TM) robotic stroke therapy device

Intervention Type DEVICE

The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.

Control

Self administered home therapy program

Group Type ACTIVE_COMPARATOR

Home Therapy Program

Intervention Type DEVICE

Subjects in the control group will be instructed in a self administered home therapy program

Interventions

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Hand Mentor (TM) robotic stroke therapy device

The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.

Intervention Type DEVICE

Home Therapy Program

Subjects in the control group will be instructed in a self administered home therapy program

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Unilateral ischemic or hemorrhagic stroke
* within 6 months of admission to in-patient rehabilitation
* Persistent hemiparesis
* Proximal Upper Extremity voluntary activity
* Preserved cognitive function
* Difficult access to an organized stroke rehabilitation program

Exclusion Criteria

* Not independent before stroke
* Hemispatial neglect
* Significant other illnesses
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Kinetic Muscles

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jay Alberts, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Steve L Wolf, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University Medical School

Locations

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Emory University School of Medicine

Atlanta, Georgia, United States

Site Status

Cleveland Clinic Foujndation

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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Linder SM, Rosenfeldt AB, Bay RC, Sahu K, Wolf SL, Alberts JL. Improving Quality of Life and Depression After Stroke Through Telerehabilitation. Am J Occup Ther. 2015 Mar-Apr;69(2):6902290020p1-10. doi: 10.5014/ajot.2015.014498.

Reference Type DERIVED
PMID: 26122686 (View on PubMed)

Wolf SL, Sahu K, Bay RC, Buchanan S, Reiss A, Linder S, Rosenfeldt A, Alberts J. The HAAPI (Home Arm Assistance Progression Initiative) Trial: A Novel Robotics Delivery Approach in Stroke Rehabilitation. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):958-68. doi: 10.1177/1545968315575612. Epub 2015 Mar 17.

Reference Type DERIVED
PMID: 25782693 (View on PubMed)

Linder SM, Rosenfeldt AB, Reiss A, Buchanan S, Sahu K, Bay CR, Wolf SL, Alberts JL. The home stroke rehabilitation and monitoring system trial: a randomized controlled trial. Int J Stroke. 2013 Jan;8(1):46-53. doi: 10.1111/j.1747-4949.2012.00971.x.

Reference Type DERIVED
PMID: 23280269 (View on PubMed)

Other Identifiers

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1RC3NS070646-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NS070646

Identifier Type: -

Identifier Source: org_study_id