Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00758147
• Collaborator: Ono Academic College (Other)
• Enrollment: 30
• Location: 1
• Duration (Months): 19
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Exercise with force feedback joystick	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Assessment of Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke
• Study Start Date: Nov 1, 2008
• Anticipated Primary Completion Date: Nov 1, 2009
• Anticipated Study Completion Date: Jun 1, 2010

Outcome Measures

Primary Outcome Measures

1. Fugl Meyer impairment scale [1 month]

2. Wolf Motor Function Test [One month]

Secondary Outcome Measures

1. Satisfaction survey about the use of the joystick [1 Month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 86 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beit Rivka Geriatric Hospital	Petach Tikva		Israel	49245

Sponsors and Collaborators

• Rabin Medical Center
• Ono Academic College

Investigators

• Principal Investigator: Shai Brill, M.D., Beit Rivka Geriatric Hospital
• Study Director: Heidi Sugarman, PhD, Ono Academic College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00758147
• Other Study ID Numbers: BGC085012CTIL
• First Posted: Sep 23, 2008
• Last Update Posted: Sep 23, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: force feedback joystick; stroke; haptics; kinematics; rehabilitation; robotics; Force feedback joystick in stroke rehabilitation
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Sep 23, 2008