Study of Hand Therapy 3 to 24 Months After Stroke

Completed

Phase N/A Results N/A

Trial Description

The primary aim of this study is to investigate the effectiveness of the use of a robotic hand therapy device in the home environment. We hypothesize that the therapy group will improve hand function more than a customary and usual care group.

Detailed Description

Many stroke survivors have significant limitations of upper extremity function which impacts many important activities such as eating, dressing and personal care. Studies show that to be effective in increasing functional independence, therapy must involve active participation of the patient and repetitive training. Robotic therapy offers a means of transferring some of this essential, but time consuming, therapy into the home. Seventy subjects (3 to 12 months post stroke)are being randomized to a control group that utilizes an innovative robotic hand therapy device in the home for three months or a control group that receives no device treatment. Clinical motor function and quality of life measures will compare the groups before intervention, immediately after, and 3 months later. The control group will receive device treatment for 3 months following their final evaluation. The results will provide valuable data on the ability of monitored home therapy to provide effective treatment. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.

Conditions

Interventions

  • The Hand Mentor Other
    Intervention Desc: Active repetitive motion hand therapy device designed for use in therapy clinics to improve outcomes in stroke rehabilitation.
  • Hand Mentor (Hand Mentor)Device
    Other Names: Hand Mentor Home
    Intervention Desc: Use of the Hand Mentor therapy device at home for 6 weeks. Therapy programs include spasticity reduction, motor control, and emg biofeedback for encouraging activity.
    ARM 1: Kind: Experimental
    Label: A
    Description: Hand Mentor

Trial Design

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

Patient Involvement

Patient will be randomized to a control group that utilizes an innovative robotic hand therapy device in the home for three months or a control group that receives no device treatment. Clinical motor function and quality of life measures will compare the groups before intervention, immediately after, and 3 months later.

Outcomes

Type Measure Time Frame Safety Issue
Primary Wolf Motor Function Test; Fugl-Meyer test.
Secondary Compliance with recommended use; Fugl-Meyer Test; Stoke Impact Scale.
Primary Wolf Motor Function Test Initial, 6 wks, 12 wks, 16 wks, 52 wks No
Secondary Compliance with recommended use 6 wks, 12 wks No
Secondary Fugl-Meyer Test Initial, 6 wks, 12 wks, 16 wks, 52 wks No
Secondary Stoke Impact Scale Initial, 6 wks, 12 wks, 16 wks, 52 wks No

Sponsors