The Utilization of Nintendo Wii™ in Outpatient Rehabilitation Following Total Knee Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manuel Gomez, MD, MSc., St. John's Rehab Hospital
ClinicalTrials.gov Identifier:
NCT01548664
First received: March 5, 2012
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Arthropathy of Knee Joint
Other: Wii Fit
Other: Lower Extremity Exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Utilization of Nintendo Wii™ in Outpatient Rehabilitation Following Total Knee Replacement

Resource links provided by NLM:


Further study details as provided by St. John's Rehab Hospital:

Primary Outcome Measures:
  • Length of outpatient rehab stay (LOS) [ Time Frame: From admission to discharge, an expected average of 5 weeks. ] [ Designated as safety issue: No ]
    Days from admission to discharge from the outpatient rehabilitation program


Secondary Outcome Measures:
  • Lower Extremity Functional Scale [ Time Frame: From admission to discharge, an expected average of 5 weeks. ] [ Designated as safety issue: No ]
    The Lower Extremity Functional Scale will be administer on the first study visit and every two weeks until discharged from outpatient physiotherapy services by their treating clinician.


Enrollment: 50
Study Start Date: May 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nintendo Wii FitTM
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
15 minutes of gaming activity on the Wii Fit™ following each regularly scheduled 60 minute physiotherapy session, in a separate treatment area.
Other Name: Nintendo Wii Fit
Active Comparator: Lower extremity exercise
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
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.

Detailed Description:

The use of video games in rehabilitation is growing in popularity and frequency. The Nintendo Wii™ gaming system in particular, is gaining increased attention in the rehabilitation setting. There is currently very little evidence to support its clinical use. Canadian total knee replacement (TKR) rates have risen significantly in the past decade and its patient demographic has shifted to reflect a younger overall population. These changes indicate increased emphasis on TKR patients returning to higher levels of function and the potential need for new intervention options when caring for these patients. The Nintendo Wii™ Sports application has the potential to encourage standing, while participating in an interesting and engaging activity. The objective of this study is to determine whether the utilization of the Nintendo Wii™ gaming system, as an adjunct to standard outpatient rehabilitation therapy, influence outcomes of patients following total knee replacement.

Patients who consent to participate in this study will be randomized to either a control group which will receive 15 minutes of lower extremity exercise or a study group which will receive 15 minutes of gaming activity on the Wii Fit™. Both control and study interventions will be provided following each regularly scheduled 60 minute physiotherapy session, in a separate treatment area. The Nintendo Wii™ console and its accompanying Wii™ Sports game will be utilized for the purposes of this study. To minimize rotational movement and therefore the risk of injury following total knee replacement, only the tennis and bowling games will be used. It will be required that these games are played in standing position. Without including the time required for start-up, each session of Nintendo Wii™ game activity will be 15 minutes in duration, and will be provided twice weekly.

Recovery status will be measured in all participants on admission, and every 2 weeks until discharge, an expected average of 5 weeks. A combination of self-administered questionnaires, objective and subjective outcome measures will be used to measure function (2 Minute Walk Test, Lower Extremity Functional Scale) range of motion (Goniometry), pain (Numeric Pain Rating Scale) and satisfaction with therapy services. Change within each measure will be statistically analyzed to detect whether a significant difference exists between control and study groups. It is projected that 60 patients will be recruited for this study. Patients in the study group could potentially benefit from increased improvements in pain, physical status, function, and satisfaction at the completion of their outpatient rehabilitation therapy program.

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  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: NCT01548664

Locations
Canada, Ontario
St. John's Rehab Hospital
Toronto, Ontario, Canada, M2M 2G1
Sponsors and Collaborators
Manuel Gomez, MD, MSc.
Investigators
Principal Investigator: Vera Fung, BSc, MSc.PT. St. John's Rehab Hospital
  More Information

No publications provided by St. John's Rehab Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Manuel Gomez, MD, MSc., Director of the Clinical Research Department, St. John's Rehab Hospital
ClinicalTrials.gov Identifier: NCT01548664     History of Changes
Other Study ID Numbers: 2009-02
Study First Received: March 5, 2012
Last Updated: February 25, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. John's Rehab Hospital:
Total knee replacement
Outpatient
Randomized controlled trial
Video games

ClinicalTrials.gov processed this record on October 29, 2014