search
Back to results

Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Exercise with force feedback joystick
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring force feedback joystick, stroke, haptics, kinematics, rehabilitation, robotics, Force feedback joystick in stroke rehabilitation

Eligibility Criteria

65 Years - 86 Years (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Beit Rivka Geriatric Hospital

Outcomes

Primary Outcome Measures

Fugl Meyer impairment scale
Wolf Motor Function Test

Secondary Outcome Measures

Satisfaction survey about the use of the joystick

Full Information

First Posted
September 21, 2008
Last Updated
September 22, 2008
Sponsor
Rabin Medical Center
Collaborators
Ono Academic College
search

1. Study Identification

Unique Protocol Identification Number
NCT00758147
Brief Title
Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke
Official Title
Assessment of Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rabin Medical Center
Collaborators
Ono Academic College

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
force feedback joystick, stroke, haptics, kinematics, rehabilitation, robotics, Force feedback joystick in stroke rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Exercise with force feedback joystick
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl Meyer impairment scale
Time Frame
1 month
Title
Wolf Motor Function Test
Time Frame
One month
Secondary Outcome Measure Information:
Title
Satisfaction survey about the use of the joystick
Time Frame
1 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shai Brill, M.D.
Organizational Affiliation
Beit Rivka Geriatric Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heidi Sugarman, PhD
Organizational Affiliation
Ono Academic College
Official's Role
Study Director
Facility Information:
Facility Name
Beit Rivka Geriatric Hospital
City
Petach Tikva
ZIP/Postal Code
49245
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shai Brill, M.D.
Phone
972-3-9373811
Email
shaybr@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Riki Brown, MSc
Phone
972-3-9373974
Email
rikib2@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Shai Brill, MD

12. IPD Sharing Statement

Learn more about this trial

Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke

We'll reach out to this number within 24 hrs