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Telerehabilitation for the Hand and Arm After Stroke and Traumatic Brain Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Ono Academic College.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ono Academic College
ClinicalTrials.gov Identifier:
NCT00295399
First received: February 21, 2006
Last updated: August 11, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Cerebrovascular Accident
Traumatic Brain Injury
Device: The Jerusalem Telerehabilitation System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ono Academic College:

Primary Outcome Measures:
  • Modified motor assessment scale [ Designated as safety issue: No ]
  • Kinematic analysis [ Designated as safety issue: No ]
  • Feedback questionnaires for patients, therapists and caretakers [ Designated as safety issue: Yes ]

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295399

Contacts
Contact: Heidi Sugarman, Ph.D. 972-2652-4495 hsugarman@hakirya.ac.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Chaim Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel, 52662
Sponsors and Collaborators
Ono Academic College
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
  More Information

Publications:
Responsible Party: Dr. Heidi Sugarman, Principal Investigator, Ono Academic College
ClinicalTrials.gov Identifier: NCT00295399     History of Changes
Other Study ID Numbers: JTRS001
Study First Received: February 21, 2006
Last Updated: August 11, 2008
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Ono Academic College:
cerebrovascular accident
traumatic brain injury
stroke
telerehabilitation

Additional relevant MeSH terms:
Brain Injuries
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Vascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014