Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke

Stroke Clinical Trial

Official title:

Assessment of Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00758147
• Other study ID #: BGC085012CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: September 21, 2008
• Last updated: September 22, 2008
• Start date: November 2008
• Est. completion date: June 2010

Study information

• Verified date: September 2008
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the influence of force feedback joysticks and haptic feedback in improving upper limb rehabilitation outcomes following stroke.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 86 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Exercise with force feedback joystick
System consists of a commercially available force feedback joystick, and specially written software. Patients will work with the system 5 times a week for 4 weeks, a half hour each time, 2 weeks with visual and haptic feedback and 2 weeks without the feedback.

Locations

Country	Name	City	State
Israel	Beit Rivka Geriatric Hospital	Petach Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Ono Academic College

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer impairment scale		1 month	No
Primary	Wolf Motor Function Test		One month	No
Secondary	Satisfaction survey about the use of the joystick		1 Month	No