- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00295399
Telerehabilitation for the Hand and Arm After Stroke and Traumatic Brain Injury
August 11, 2008 updated by: Ono Academic College
The goal of this project is to develop a low-cost, user-friendly, portable telerehabilitation system for physical therapy of the upper limb after stroke or traumatic brain injury.
The system is based on the use of a commercially available force feedback joystick and will work with an ordinary home PC and a standard high-speed internet connection.
Using the joystick, the patient will perform exercises designed to aid in recovering motor function of the hand and arm.
The joystick will be programmed to either assist or resist the patient's movements.
The system will include sophisticated analysis of patient status and progress to provide the therapist and physician with detailed information.
In the first phase of the study, we will develop the system in cooperation with the physical therapy staff and other rehabilitation specialists.
The investigators will examine the usability, comfort, safety and therapeutic benefit of the system.
In the second phase of the study, the investigators will employ the system in patients' homes, using the internet to connect to rehabilitation specialists in the clinic.
The study hypothesis is that it is possible to adapt commercially available, low cost gaming equipment such as force feedback joysticks to provide therapy for patients in their own homes, and that patients will be able to work with this system and will find it enjoyable and helpful for recovering motor function.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
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 Contact
- Name: Heidi Sugarman, Ph.D.
- Phone Number: 972-2652-4495
- Email: hsugarman@hakirya.ac.il
Study Locations
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Jerusalem, Israel, 91120
- Hadassah Medical Organization
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Tel Hashomer, Israel, 52662
- Chaim Sheba Medical Center
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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
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Post-cerebrovascular accident or post-traumatic brain injury
- In medically stable condition
- Resident in Israel
Note: In addition there will be healthy, age-matched volunteers
Exclusion Criteria:
- History of psychiatric illness
- Grade of less than 23 in the Mini-Mental Test
- Inability to understand informed consent form
- Inability to follow 3-step instructions
- Pregnancy
- Receptive aphasia
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Modified motor assessment scale
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Kinematic analysis
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Feedback questionnaires for patients, therapists and caretakers
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Heidi Sugarman, Ph.D., Ono Academic College
- Principal Investigator: Joseph Tiran, PhD, Ben Gurion University, Beer Sheva, Israel
- Principal Investigator: Ehud Dayan, BSc, Sonarion Hadassah Virtual Reality 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.
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 Registration Dates
First Submitted
February 21, 2006
First Submitted That Met QC Criteria
February 21, 2006
First Posted (Estimate)
February 23, 2006
Study Record Updates
Last Update Posted (Estimate)
August 13, 2008
Last Update Submitted That Met QC Criteria
August 11, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JTRS001
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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