Clinical trial NCT00295399: Telerehabilitation for the Hand and Arm After Stroke and Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Accident
Traumatic Brain Injury
Keywords: cerebrovascular accident
traumatic brain injury
stroke
telerehabilitation
Lead sponsor: Ono Academic College
Sponsor class: OTHER
First posted: 2006-02-23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Modified motor assessment scale
measure: Kinematic analysis
measure: Feedback questionnaires for patients, therapists and caretakers
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Ono Academic College
name: Heidi Sugarman, Ph.D.
role: STUDY_CHAIR
affiliation: Ben Gurion University, Beer Sheva, Israel
name: Joseph Tiran, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sonarion Hadassah Virtual Reality Center
name: Ehud Dayan, BSc
role: PRINCIPAL_INVESTIGATOR
References:
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.