Trial record 13 of 4037 for:
stroke
Rehabilitation of the Stroke Hand at Home (HAAPI)
This study is currently recruiting participants.
Verified April 2013 by Kinetic Muscles
Sponsor:
Kinetic Muscles
Collaborators:
The Cleveland Clinic
Emory University
Information provided by (Responsible Party):
Kinetic Muscles
ClinicalTrials.gov Identifier:
NCT01144715
First received: June 11, 2010
Last updated: April 8, 2013
Last verified: April 2013
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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.
| Estimated Enrollment: | 96 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | May 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
Contacts
| Contact: James B Koeneman, Ph.D. | 480-557-0448 | jkoeneman@kineticmuscles.com |
| Contact: Erin Donahue, MBA | 480-557-0448 | edonahue@kineticmuscles.com |
Locations
| United States, Georgia | |
| Emory University School of Medicine | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Steve L Wolf, PhD 404-712-4801 swolf@emory.edu | |
| Contact: Komal Sahu, Therapist 404-772-8222 komal.sahu@emoryhealthcare.org | |
| Principal Investigator: Steve L Wolf, PhD | |
| United States, Ohio | |
| Cleveland Clinic Foujndation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Jay Alberts, PhD 216-445-3222 albertj@ccf.org | |
| Contact: Anson Rosenfelt, Therapist 216-445-3277 rosenfa2@ccf.org | |
| Principal Investigator: Jay Alberts, PhD | |
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: | April 8, 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 May 23, 2013