Telerehabilitation for the Hand and Arm After Stroke and Traumatic Brain Injury
Primary Purpose
Cerebrovascular Accident, Traumatic Brain Injury
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
The Jerusalem Telerehabilitation System
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring cerebrovascular accident, traumatic brain injury, stroke, telerehabilitation
Eligibility Criteria
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
Sites / Locations
- Hadassah Medical Organization
- Chaim Sheba Medical Center
Outcomes
Primary Outcome Measures
Modified motor assessment scale
Kinematic analysis
Feedback questionnaires for patients, therapists and caretakers
Secondary Outcome Measures
Full Information
NCT ID
NCT00295399
First Posted
February 21, 2006
Last Updated
August 11, 2008
Sponsor
Ono Academic College
1. Study Identification
Unique Protocol Identification Number
NCT00295399
Brief Title
Telerehabilitation for the Hand and Arm After Stroke and Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ono Academic College
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Traumatic Brain Injury
Keywords
cerebrovascular accident, traumatic brain injury, stroke, telerehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
The Jerusalem Telerehabilitation System
Primary Outcome Measure Information:
Title
Modified motor assessment scale
Title
Kinematic analysis
Title
Feedback questionnaires for patients, therapists and caretakers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Sugarman, Ph.D.
Phone
972-2652-4495
Email
hsugarman@hakirya.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Sugarman, Ph.D.
Organizational Affiliation
Ono Academic College
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joseph Tiran, PhD
Organizational Affiliation
Ben Gurion University, Beer Sheva, Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ehud Dayan, BSc
Organizational Affiliation
Sonarion Hadassah Virtual Reality Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52662
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
16640475
Citation
Sugarman H, Dayan E, Weisel-Eichler A, Tiran J. The Jerusalem TeleRehabilitation System, a new low-cost, haptic rehabilitation approach. Cyberpsychol Behav. 2006 Apr;9(2):178-82. doi: 10.1089/cpb.2006.9.178.
Results Reference
background
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Telerehabilitation for the Hand and Arm After Stroke and Traumatic Brain Injury
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