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Rehabilitation of the Stroke Hand at Home (HAAPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01144715
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : November 27, 2014
Last Update Posted : November 27, 2014
The Cleveland Clinic
Emory University
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Kinetic Muscles

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Device: Hand Mentor (TM) robotic stroke therapy device Device: Home Therapy Program Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Innovative Home Stroke Rehabilitation and Monitoring System
Study Start Date : June 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Hand Mentor Therapy
Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
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.

Active Comparator: Control
Self administered home therapy program
Device: Home Therapy Program
Subjects in the control group will be instructed in a self administered home therapy program

Primary Outcome Measures :
  1. Action Research Arm Test (ARAT) [ Time Frame: End of treatment at 8 weeks post enrolment ]
    The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome.

Secondary Outcome Measures :
  1. Wolf Motor Function Test [ Time Frame: End of treatment at 8 weeks post enrolment ]
    The Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks. The WMFT is a 17-item measure used to assess activity limitations of the upper extremity. It is comprised of 2 strength items and 15 timed task performance items. The task performance items begin with the measurement of simple proximal movements and progress to more complex distal and whole limb movements. The WMFT yields two scores: 1) a functional ability score quantifying quality of performance, and 2) a timed score quantifying speed of performance in seconds. A shorter time is better outcome.

  2. Fugl-Meyer Upper Extremity Test [ Time Frame: End of Treatment at 8 weeks post enrolment ]
    Upper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test (FMA). The FMA is an impairment-based measure consisting of 33 movements with higher scores indicating increased ability of the patient to move out of synergistic patterns toward more isolated movements. Movement quality of the affected UE is compared to the non-affected UE on 0-2 ordinal scale with 0 indicating no movement at all, 1 indicating partial movement of the affected extremity, and 2 indicating movement equivalent to the non-affected UEs. The score ranges from 0-to-66.

  3. Stroke Impact Scale (SIS) [ Time Frame: End of treatment at 8 weeks post enrolment ]
    Quality of Life changes are measured with the Stroke Impact Scale questionnaire. The SIS is a self-rated QOL questionnaire that addresses several domains following stroke: physical strength, memory, feelings and emotions, communication, activities of daily living (ADL), mobility, hand use, meaningful activities, and overall percentage recovery from the stroke. We report the Hand Function subscale, which ranges from 0-to-100. A higher score reflects better hand function.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01144715

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United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Ohio
Cleveland Clinic Foujndation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Kinetic Muscles
The Cleveland Clinic
Emory University
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Jay Alberts, PhD The Cleveland Clinic
Principal Investigator: Steve L Wolf, PhD Emory University Medical School
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kinetic Muscles Identifier: NCT01144715    
Other Study ID Numbers: NS070646
1RC3NS070646-01 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2010    Key Record Dates
Results First Posted: November 27, 2014
Last Update Posted: November 27, 2014
Last Verified: October 2014
Keywords provided by Kinetic Muscles:
Stroke Rehabilitation
Home rehabilitation
robotic therapy
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases