Rehabilitation of the Stroke Hand at Home

Stroke Clinical Trial

— HAAPI  

Official title:

An Innovative Home Stroke Rehabilitation and Monitoring System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144715
• Other study ID #: NS070646
• Secondary ID: 1RC3NS070646-01
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2010
• Last updated: November 24, 2014
• Start date: June 2010
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: Kinetic Muscles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• Home Therapy Program
Subjects in the control group will be instructed in a self administered home therapy program

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Cleveland Clinic Foujndation	Cleveland	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Kinetic Muscles	Emory University, National Institute of Neurological Disorders and Stroke (NINDS), The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Arm Test (ARAT)	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.	End of treatment at 8 weeks post enrolment	No
Secondary	Wolf Motor Function Test	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.	End of treatment at 8 weeks post enrolment	No
Secondary	Fugl-Meyer Upper Extremity Test	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.	End of Treatment at 8 weeks post enrolment	No
Secondary	Stroke Impact Scale (SIS)	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.	End of treatment at 8 weeks post enrolment	No