- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00435617
Study of Hand Therapy 3 to 24 Months After Stroke
July 18, 2012 updated by: James Koeneman, Kinetic Muscles
Clinical Assessment of a Massed Practice Therapy Device
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Arizona State University, College of Nursing & Healthcare Innovation
-
-
Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wolf Motor Function Test
Time Frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks
|
Initial, 6 wks, 12 wks, 16 wks, 52 wks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compliance with recommended use
Time Frame: 6 wks, 12 wks
|
6 wks, 12 wks
|
Fugl-Meyer Test
Time Frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks
|
Initial, 6 wks, 12 wks, 16 wks, 52 wks
|
Stoke Impact Scale
Time Frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks
|
Initial, 6 wks, 12 wks, 16 wks, 52 wks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: James B Koeneman, Ph.D., Kinetic Muscles, Inc.
- Study Director: Steven L Wolf, Ph.D., PT, Emory University Medical School
- Study Director: Richard Herman, MD, Banner Good Samaritan Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
February 13, 2007
First Submitted That Met QC Criteria
February 14, 2007
First Posted (Estimate)
February 15, 2007
Study Record Updates
Last Update Posted (Estimate)
July 20, 2012
Last Update Submitted That Met QC Criteria
July 18, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R44HD041805 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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