CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 99 enrolled
Drug / intervention
Hand Mentor (TM) robotic stroke therapy device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01144715
NCT01144715Phase 4Completed

An Innovative Home Stroke Rehabilitation and Monitoring System

Kinetic Muscles·interventional·Posted Jun 16, 2010·Updated Nov 27, 2014

In Brief

A Phase 4 clinical trial evaluating Hand Mentor (TM) robotic stroke therapy device and Home Therapy Program for Stroke. Completed, enrolled 99 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 16, 2010
Enrollment StartJun 1, 2010
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.0 years ago

Interventions

Hand Mentor (TM) robotic stroke therapy devicedevice

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.

Home Therapy Programdevice

Subjects in the control group will be instructed in a self administered home therapy program