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

Arthropathy of Knee Joint Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548664
• Other study ID #: 2009-02
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2012
• Last updated: February 25, 2014
• Start date: May 2009
• Est. completion date: September 2010

Study information

• Verified date: February 2014
• Source: St. John's Rehab Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthropathy of Knee Joint

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	St. John's Rehab Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Manuel Gomez, MD, MSc.

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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): e3

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	From admission to discharge, an expected average of 5 weeks.	No