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Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke

NCT ID: NCT00758147

Last Updated: 2008-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Stroke

Keywords

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force feedback joystick stroke haptics kinematics rehabilitation robotics Force feedback joystick in stroke rehabilitation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Academic College

OTHER

Sponsor Role collaborator

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Beit Rivka Geriatric Center

Principal Investigators

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Shai Brill, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beit Rivka Geriatric Hospital

Heidi Sugarman, PhD

Role: STUDY_DIRECTOR

Ono Academic College

Locations

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Beit Rivka Geriatric Hospital

Petah Tikva, , Israel

Site Status

Countries

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Israel

Facility Contacts

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Shai Brill, M.D.

Role: primary

Riki Brown, MSc

Role: backup

Other Identifiers

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BGC085012CTIL

Identifier Type: -

Identifier Source: org_study_id