The Utilization of Nintendo Wii™ in Outpatient Rehabilitation Following Total Knee Replacement
Primary Purpose
Arthropathy of Knee Joint
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Wii Fit
Lower Extremity Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Arthropathy of Knee Joint focused on measuring Total knee replacement, Outpatient, Randomized controlled trial, Video games
Eligibility 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.
Sites / Locations
- St. John's Rehab Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nintendo Wii FitTM
Lower extremity exercise
Arm Description
Fifteen minutes of gaming activity on the Wii Fit™ following each regularly scheduled 60 minute physiotherapy session, in a separate treatment area.
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
Outcomes
Primary Outcome Measures
Length of outpatient rehab stay (LOS)
Days from admission to discharge from the outpatient rehabilitation program
Secondary Outcome Measures
Lower Extremity Functional Scale
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.
Full Information
NCT ID
NCT01548664
First Posted
March 5, 2012
Last Updated
February 25, 2014
Sponsor
Manuel Gomez, MD, MSc.
1. Study Identification
Unique Protocol Identification Number
NCT01548664
Brief Title
The Utilization of Nintendo Wii™ in Outpatient Rehabilitation Following Total Knee Replacement
Official Title
The Utilization of Nintendo Wii™ in Outpatient Rehabilitation Following Total Knee Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Manuel Gomez, MD, MSc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee Joint
Keywords
Total knee replacement, Outpatient, Randomized controlled trial, Video games
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nintendo Wii FitTM
Arm Type
Experimental
Arm Description
Fifteen minutes of gaming activity on the Wii Fit™ following each regularly scheduled 60 minute physiotherapy session, in a separate treatment area.
Arm Title
Lower extremity exercise
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Wii Fit
Other Intervention Name(s)
Nintendo Wii Fit
Intervention Description
15 minutes of gaming activity on the Wii Fit™ following each regularly scheduled 60 minute physiotherapy session, in a separate treatment area.
Intervention Type
Other
Intervention Name(s)
Lower Extremity Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of outpatient rehab stay (LOS)
Description
Days from admission to discharge from the outpatient rehabilitation program
Time Frame
From admission to discharge, an expected average of 5 weeks.
Secondary Outcome Measure Information:
Title
Lower Extremity Functional Scale
Description
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.
Time Frame
From admission to discharge, an expected average of 5 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Fung, BSc, MSc.PT.
Organizational Affiliation
St. John's Rehab Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. John's Rehab Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2M 2G1
Country
Canada
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
PubMed Identifier
22898573
Citation
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.
Results Reference
derived
Links:
URL
http://intranet.stjohnsrehab.com/Research/documents/2009%20SJRH%20Research%20Activities.pdf
Description
Page 4, number 2 of the above document - St. John's Rehab Hospital website, research projects webpage
Learn more about this trial
The Utilization of Nintendo Wii™ in Outpatient Rehabilitation Following Total Knee Replacement
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