NCT01548664

Brief Summary

The purpose of this study is to identify whether the utilization of the Nintendo Wii™ gaming system, as an adjunct to conventional outpatient rehabilitation therapy, influence outcomes of patients following total knee replacement (TKR). The investigators hypothesize that the Nintendo Wii™ gaming system has a positive influence in the outcomes of patients following TKR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

March 5, 2012

Last Update Submit

February 25, 2014

Conditions

Arthropathy of Knee Joint

Keywords

Total knee replacementOutpatientRandomized controlled trialVideo games

Outcome Measures

Primary Outcomes (1)

  • Length of outpatient rehab stay (LOS)

    Days from admission to discharge from the outpatient rehabilitation program

    From admission to discharge, an expected average of 5 weeks.

Secondary Outcomes (1)

  • Lower Extremity Functional Scale

    From admission to discharge, an expected average of 5 weeks.

Study Arms (2)

Nintendo Wii FitTM

EXPERIMENTAL

Fifteen minutes of gaming activity on the Wii Fit™ following each regularly scheduled 60 minute physiotherapy session, in a separate treatment area.

Other: Wii Fit

Lower extremity exercise

ACTIVE COMPARATOR

Fifteen minutes of lower extremity exercises that addressed balance, posture, weight shifting and strengthening were provided bilaterally, following each regularly scheduled 60 minute physiotherapy session, in a separate treatment area

Other: Lower Extremity Exercise

Interventions

Wii FitOTHER

15 minutes of gaming activity on the Wii Fit™ following each regularly scheduled 60 minute physiotherapy session, in a separate treatment area.

Also known as: Nintendo Wii Fit
Nintendo Wii FitTM
Lower Extremity ExerciseOTHER

Fifteen minutes of lower extremity exercise that addressed balance, posture, weight shifting and strengthening provided bilaterally following each regularly scheduled 60 minute physiotherapy session, in a separate treatment area.

Lower extremity exercise

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients with full lower extremity weight bearing
  • Requiring physiotherapy treatment twice weekly for Total Knee Arthroplasty rehabilitation.

You may not qualify if:

  • Individuals with visual impairments
  • Active painful osteoarthritis in the contralateral lower extremity
  • Patients with uncorrected visual impairments
  • English language barriers or impairments to their ability to follow instruction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. John's Rehab Hospital

Toronto, Ontario, M2M 2G1, Canada

Location

Related Publications (2)

  • Fung V, Ho A, Shaffer J, Gomez M. The Utilization of Nintendo Wii Fit in the Rehabilitation of Outpatients Following Total Knee Replacements: Preliminary Results of a Randomized Controlled Trial. Archives of Physical Medicine and Rehabilitation 91(10): e37, 2010.

    RESULT

  • Fung V, Ho A, Shaffer J, Chung E, Gomez M. Use of Nintendo Wii Fit in the rehabilitation of outpatients following total knee replacement: a preliminary randomised controlled trial. Physiotherapy. 2012 Sep;98(3):183-8. doi: 10.1016/j.physio.2012.04.001. Epub 2012 Jul 10.

    PMID: 22898573DERIVED

Study Officials

  • Vera Fung, BSc, MSc.PT.

    St. John's Rehab Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the Clinical Research Department

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 8, 2012

Study Start

May 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations

CA(1)