NCT00758147

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 23, 2008

Status Verified

September 1, 2008

Enrollment Period

1 year

First QC Date

September 21, 2008

Last Update Submit

September 22, 2008

Conditions

Stroke

Keywords

force feedback joystickstrokehapticskinematicsrehabilitationroboticsForce feedback joystick in stroke rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Fugl Meyer impairment scale

    1 month

  • Wolf Motor Function Test

    One month

Secondary Outcomes (1)

  • Satisfaction survey about the use of the joystick

    1 Month

Interventions

Exercise with force feedback joystickDEVICE

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.

Eligibility Criteria

Age65 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Medically stable post first stroke patients
  • Score of more than 17 on the Mini Mental Scale Test(MMST)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beit Rivka Geriatric Hospital

Petah Tikva, 49245, Israel

Location

MeSH Terms

Conditions

Stroke

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Shai Brill, M.D.

    Beit Rivka Geriatric Hospital

    PRINCIPAL INVESTIGATOR

  • Heidi Sugarman, PhD

    Ono Academic College

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2008

First Posted

September 23, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2009

Study Completion

June 1, 2010

Last Updated

September 23, 2008

Record last verified: 2008-09

Locations

IL(1)