NCT01144715

Rehabilitation of the Stroke Hand at Home

An Innovative Home Stroke Rehabilitation and Monitoring System

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Kinetic Muscles · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Stroke

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-06-16
• Last updated: 2014-11-27
• Results posted: 2014-11-27

Locations

2 sites across 1 country: United States