Rehabilitation of the Stroke Hand at Home (HAAPI)

Kinetic Muscles

Status and phase: Completed; Phase 4

Conditions: Stroke

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

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01144715

1RC3NS070646-01 (U.S. NIH Grant/Contract)

NS070646

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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99 participants in 2 patient groups

Hand Mentor Therapy

Experimental group

Description:

Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks

Treatment:

Device: Hand Mentor (TM) robotic stroke therapy device

Control

Active Comparator group

Description:

Self administered home therapy program

Treatment:

Device: Home Therapy Program