Study of Hand Therapy 3 to 24 Months After Stroke

Not Applicable

Completed

• Conditions: Cerebrovascular Accident
• Interventions: Device: Hand Mentor

• Registration Number: NCT00435617
• Lead Sponsor: Kinetic Muscles

Brief Summary

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2007-02-13
• Study First Submitted QC: 2007-02-14
• Study First Posted: 2007-02-15
• Primary Completion: 2009-05
• Study Completion: 2010-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-18
• Last Update Posted: 2012-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• 3 to 24 months post stroke
• Able to extend wrist and fingers at least 10 degrees
• Functional hearing and vision
• Able to follow instructions
• Lives at home, not institution
• Stable medications for 3 months

Exclusion Criteria

• Excessive cognitive impairments
• Taking/Receiving medicines/shots to make arm/hand less stiff
• Severe pain in the impaired arm
• Stroke was more than 24 months ago

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Hand Mentor	Hand Mentor

Primary Outcome Measures

Name	Time	Method
Wolf Motor Function Test	Initial, 6 wks, 12 wks, 16 wks, 52 wks

Secondary Outcome Measures

Name	Time	Method
Compliance with recommended use	6 wks, 12 wks
Fugl-Meyer Test	Initial, 6 wks, 12 wks, 16 wks, 52 wks
Stoke Impact Scale	Initial, 6 wks, 12 wks, 16 wks, 52 wks

Trial Locations

Locations (2)

Arizona State University, College of Nursing & Healthcare Innovation; 🇺🇸 Phoenix, Arizona, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States