Rehabilitation of the Stroke Hand at Home

Phase 4

Completed

Conditions: Stroke

Interventions: Device: Hand Mentor (TM) robotic stroke therapy device
Device: Home Therapy Program

Registration Number: NCT01144715

Lead Sponsor: Kinetic Muscles

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 99

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hand Mentor Therapy	Hand Mentor (TM) robotic stroke therapy device	Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Control	Home Therapy Program	Self administered home therapy program

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	End of treatment at 8 weeks post enrolment	The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome.

Secondary Outcome Measures

Name	Time	Method
Wolf Motor Function Test	End of treatment at 8 weeks post enrolment	The Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks. The WMFT is a 17-item measure used to assess activity limitations of the upper extremity. It is comprised of 2 strength items and 15 timed task performance items. The task performance items begin with the measurement of simple proximal movements and progress to more complex distal and whole limb movements. The WMFT yields two scores: 1) a functional ability score quantifying quality of performance, and 2) a timed score quantifying speed of performance in seconds. A shorter time is better outcome.
Fugl-Meyer Upper Extremity Test	End of Treatment at 8 weeks post enrolment	Upper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test (FMA). The FMA is an impairment-based measure consisting of 33 movements with higher scores indicating increased ability of the patient to move out of synergistic patterns toward more isolated movements. Movement quality of the affected UE is compared to the non-affected UE on 0-2 ordinal scale with 0 indicating no movement at all, 1 indicating partial movement of the affected extremity, and 2 indicating movement equivalent to the non-affected UEs. The score ranges from 0-to-66.
Stroke Impact Scale (SIS)	End of treatment at 8 weeks post enrolment	Quality of Life changes are measured with the Stroke Impact Scale questionnaire. The SIS is a self-rated QOL questionnaire that addresses several domains following stroke: physical strength, memory, feelings and emotions, communication, activities of daily living (ADL), mobility, hand use, meaningful activities, and overall percentage recovery from the stroke. We report the Hand Function subscale, which ranges from 0-to-100. A higher score reflects better hand function.

Trial Locations

Locations (2): Emory University School of Medicine
🇺🇸
Atlanta, Georgia, United States
Cleveland Clinic Foujndation
🇺🇸
Cleveland, Ohio, United States