This trial is active, not recruiting.

Condition stroke
Treatments hand mentor (tm) robotic stroke therapy device, home therapy program
Phase phase 4
Sponsor Kinetic Muscles
Collaborator The Cleveland Clinic
Start date June 2010
End date September 2013
Trial size 99 participants
Trial identifier NCT01144715, 1RC3NS070646-01, NS070646


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
hand mentor (tm) robotic stroke therapy device Hand Mentor (TM) 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)
Self administered home therapy program
home therapy program
Subjects in the control group will be instructed in a self administered home therapy program

Primary Outcomes

Action Research Arm Test (ARAT)
time frame: End of treatment at 8 weeks post enrolment

Secondary Outcomes

Wolf Motor Function Test
time frame: End of treatment at 8 weeks post enrolment
Fugl-Meyer Upper Extremity Test
time frame: End of Treatment at 8 weeks post enrolment
Stroke Impact Scale (SIS)
time frame: End of treatment at 8 weeks post enrolment

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title An Innovative Home Stroke Rehabilitation and Monitoring System
Principal investigator Jay Alberts, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Kinetic Muscles.