Rehabilitation of the Stroke Hand at Home (HAAPI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Cleveland Clinic
Emory University
Information provided by (Responsible Party):
Kinetic Muscles
ClinicalTrials.gov Identifier:
NCT01144715
First received: June 11, 2010
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Stroke
Device: Hand Mentor (TM) robotic stroke therapy device
Device: Home Therapy Program
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Innovative Home Stroke Rehabilitation and Monitoring System

Resource links provided by NLM:


Further study details as provided by Kinetic Muscles:

Primary Outcome Measures:
  • Action Research Arm Test (ARAT) [ Time Frame: End of treatment at 8 weeks post enrolment ] [ Designated as safety issue: No ]
    The amount of recovery of arm-hand function is measured with the Action Research Arm Test


Secondary Outcome Measures:
  • Wolf Motor Function Test [ Time Frame: End of treatment at 8 weeks post enrolment ] [ Designated as safety issue: No ]
    The Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks

  • Fugl-Meyer Upper Extremity Test [ Time Frame: End of Treatment at 8 weeks post enrolment ] [ Designated as safety issue: No ]
    Upper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test

  • Stroke Impact Scale (SIS) [ Time Frame: End of treatment at 8 weeks post enrolment ] [ Designated as safety issue: No ]
    Quality of Life changes are measured with the Stroke Impact Scale questionnaire.


Enrollment: 99
Study Start Date: June 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Hand Mentor (TM) stroke therapy device
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144715

Locations
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
Investigators
Principal Investigator: Jay Alberts, PhD The Cleveland Clinic
Principal Investigator: Steve L Wolf, PhD Emory University Medical School
  More Information

No publications provided by Kinetic Muscles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kinetic Muscles
ClinicalTrials.gov Identifier: NCT01144715     History of Changes
Other Study ID Numbers: NS070646, 1RC3NS070646-01
Study First Received: June 11, 2010
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Kinetic Muscles:
Stroke Rehabilitation
Home rehabilitation
robotic therapy

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014