Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ono Academic College
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00758147
First received: September 21, 2008
Last updated: September 22, 2008
Last verified: September 2008
  Purpose

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 Intervention
Stroke
Device: Exercise with force feedback joystick

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Fugl Meyer impairment scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Wolf Motor Function Test [ Time Frame: One month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Satisfaction survey about the use of the joystick [ Time Frame: 1 Month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   65 Years to 86 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758147

Locations
Israel
Beit Rivka Geriatric Hospital Not yet recruiting
Petach Tikva, Israel, 49245
Contact: Shai Brill, M.D.    972-3-9373811    shaybr@clalit.org.il   
Contact: Riki Brown, MSc    972-3-9373974    rikib2@clalit.org.il   
Principal Investigator: Shai Brill, MD         
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
  More Information

No publications provided

Responsible Party: Shai Brill M.D, Beit Rivka Geriatric Center
ClinicalTrials.gov Identifier: NCT00758147     History of Changes
Other Study ID Numbers: BGC085012CTIL
Study First Received: September 21, 2008
Last Updated: September 22, 2008
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
force feedback joystick
stroke
haptics
kinematics
rehabilitation
robotics
Force feedback joystick in stroke rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 22, 2014