- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00758147
Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke
Assessment of Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Upper limb paresis or plegia following stroke remains a significant cause of impairment and disability. Regaining function requires learning through repetitive movements and activities of daily living(ADLs).
The aim of the study in this application is to test the usability of the system in specialized rehabilitation hospital settings. In this first stage of development, after developing and testing the system together with expert physiotherapists, we will examine the system for usability (is it "user friendly"), comfort level, and therapeutic efficacy.
The system consists of an ordinary PC computer, specially written software, and a commercially available force feedback joystick. (Force feedback joysticks, are usually used for gaming; they contain miniature motors that allow the joystick to either help or resist the movements of the person using it). Patients who are unable to grasp the joystick will use a specially built arm rest that is attached to an ordinary office chair without wheels. Patients rest their forearm on the arm rest and thus can manipulate the joystick by means of movement of the shoulder and elbow joints instead of by movements of the wrist, since wrist movements are often difficult for brain damaged individuals.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Petach Tikva, Israel, 49245
- Beit Rivka Geriatric Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medically stable post first stroke patients
- Score of more than 17 on the Mini Mental Scale Test(MMST)
Exclusion Criteria:
- A history of psychiatric illness
- Inability to understand the informed consent form
- Inability to understand and follow 2-3 step instructions
- Receptive aphasia (sensory aphasia)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fugl Meyer impairment scale
Time Frame: 1 month
|
1 month
|
|
Wolf Motor Function Test
Time Frame: One month
|
One month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Satisfaction survey about the use of the joystick
Time Frame: 1 Month
|
1 Month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shai Brill, M.D., Beit Rivka Geriatric Hospital
- Study Director: Heidi Sugarman, PhD, Ono Academic College
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BGC085012CTIL
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