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

Traumatic Brain Injury Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00295399
• Other study ID #: JTRS001
• Status: Not yet recruiting
• Phase: N/A
• First received: February 21, 2006
• Last updated: August 11, 2008

Study information

• Verified date: August 2008
• Source: Ono Academic College
• Contact: Heidi Sugarman, Ph.D.
• Phone: 972-2652-4495
• Email: hsugarman[@]hakirya.ac.il
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Brain Injuries
• Cerebrovascular Accident
• Stroke
• Traumatic Brain Injury

Intervention

Device:
• The Jerusalem Telerehabilitation System

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem
Israel	Chaim Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Ono Academic College

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified motor assessment scale			No
Primary	Kinematic analysis			No
Primary	Feedback questionnaires for patients, therapists and caretakers			Yes