Rehabilitation of the Stroke Hand at Home

NCT01144715 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2014-11-27

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

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.

DEVICE

Home Therapy Program

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

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER
  • Emory University

    collaborator OTHER
  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH
  • Kinetic Muscles

    lead INDUSTRY

Principal Investigators

  • Jay Alberts, PhD · The Cleveland Clinic

  • Steve L Wolf, PhD · Emory University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01144715 on ClinicalTrials.gov