Rehabilitation of the Stroke Hand at Home "HAAPI"

Completed

Phase 4 Results

Trial Description

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

Interventions

  • Physical therapy Other
  • Hand Mentor (Hand Mentor)Device
    Other Names: Hand Mentor Home
    Intervention Desc: The Hand Mentorâ„¢ is used by Occupational Therapists and Physical Therapists that specialize in neurorehabilitation. It can be used on patients who have any injury where they need rehabilitation to help restore range of motion and strengthen muscles of their wrist and hand. Within the device, three different program types are designed to reduce spasticity, improve motor control, and recruit specific muscle groups.
  • Hand Mentor (TM) robotic stroke therapy device Device
    Other Names: Hand Mentor (TM) robotic stroke therapy device
    Intervention Desc: The goal of the Hand Mentor â„¢ (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.
    ARM 1: Kind: Experimental
    Label: Hand Mentor Therapy
    Description: Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
  • Home Therapy Program Device
    Intervention Desc: Subjects in the control group will be instructed in a self administered home therapy program
    ARM 1: Kind: Experimental
    Label: Control
    Description: Self administered home therapy program

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Patient Involvement

Treatment group uses the Hand Mentor for 2 months at homeControl group is provided instruction of a self-administered therapy program at home.

Outcomes

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

Sponsors