Study of Hand Therapy 3 to 24 Months After Stroke

Cerebrovascular Accident Clinical Trial

Official title:

Clinical Assessment of a Massed Practice Therapy Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435617
• Other study ID #: R44HD041805
• Secondary ID: R44HD041805
• Status: Completed
• Phase: N/A
• First received: February 13, 2007
• Last updated: July 18, 2012
• Start date: May 2005
• Est. completion date: May 2010

Study information

• Verified date: July 2012
• Source: Kinetic Muscles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Arizona State University, College of Nursing & Healthcare Innovation	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Kinetic Muscles	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Frick EM, Alberts JL. Combined use of repetitive task practice and an assistive robotic device in a patient with subacute stroke. Phys Ther. 2006 Oct;86(10):1378-86. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wolf Motor Function Test		Initial, 6 wks, 12 wks, 16 wks, 52 wks
Secondary	Compliance with recommended use		6 wks, 12 wks
Secondary	Fugl-Meyer Test		Initial, 6 wks, 12 wks, 16 wks, 52 wks
Secondary	Stoke Impact Scale		Initial, 6 wks, 12 wks, 16 wks, 52 wks

External Links

•   Company web site