NCT00435617

Study of Hand Therapy 3 to 24 Months After Stroke

Clinical Assessment of a Massed Practice Therapy Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Kinetic Muscles · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebrovascular Accident

Interventions

Type	Name	Description
DEVICE	Hand Mentor	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.

Timeline

• Start date: 2005-05-01
• Primary completion: 2009-05-01
• Completion: 2010-05-01
• First posted: 2007-02-15
• Last updated: 2012-07-20

Locations

2 sites across 1 country: United States