Cerebrovascular AccidentNCT00295399
Telerehabilitation for the Hand and Arm After Stroke and Traumatic Brain Injury
A study testing The Jerusalem Telerehabilitation System in people with Cerebrovascular Accident and Traumatic Brain Injury, run by Ono Academic College at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cerebrovascular Accident, Traumatic Brain Injury
- What is being tested?
- The Jerusalem Telerehabilitation System
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 2 sitesIsrael
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Medical Organization
Jerusalem, 91120
Chaim Sheba Medical Center
Tel HaShomer, 52662
About this study
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.
- Conditions
- Cerebrovascular Accident, Traumatic Brain Injury
- Being tested
- The Jerusalem Telerehabilitation System
- Keywords
- cerebrovascular accident, traumatic brain injury, stroke, telerehabilitation
- Medical subject headings
- Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Jerusalem Telerehabilitation SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified motor assessment scale
Kinematic analysis
Feedback questionnaires for patients, therapists and caretakers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Ono Academic College
- Sponsor type
- University, hospital or other
- Investigators
- Heidi Sugarman, Ph.D., Study chair, Ono Academic CollegeJoseph Tiran, PhD, Principal investigator, Ben Gurion University, Beer Sheva, IsraelEhud Dayan, BSc, Principal investigator, Sonarion Hadassah Virtual Reality Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295399
- Sponsor's protocol ID
- JTRS001
- Status last verified
- Aug 2008
- First submitted
- 21 Feb 2006
- Last updated
- 13 Aug 2008
- Results posted
- No
Publications
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.
PubMed 16640475
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation for the Hand and Arm After Stroke and Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00295399
- Acronym / sponsor ID
- JTRS001
- Conditions
- Cerebrovascular Accident, Traumatic Brain Injury
- Keywords
- cerebrovascular accident, traumatic brain injury, stroke, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Ono Academic CollegeUniversity, hospital or other
- First posted
- 23 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Jerusalem Telerehabilitation System | Device | – |
Primary outcome
Modified motor assessment scale
Kinematic analysis
Feedback questionnaires for patients, therapists and caretakers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2008.
- Background: PubMed 16640475Sugarman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Sugarman, Ph.D. study chair
Ono Academic College
Joseph Tiran, PhD principal investigator
Ben Gurion University, Beer Sheva, Israel
Ehud Dayan, BSc principal investigator
Sonarion Hadassah Virtual Reality Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Jerusalem Telerehabilitation System in people with Cerebrovascular Accident and Traumatic Brain Injury, run by Ono Academic College at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi Sugarman, Ph.D. (972-2652-4495, hsugarman@hakirya.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified motor assessment scale. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00295399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2008.