Arthropathy of Knee JointPhase 2NCT01548664
The Utilization of Nintendo Wii™ in Outpatient Rehabilitation Following Total Knee Replacement
A Phase 2 study testing Wii Fit and Lower Extremity Exercise in people with Arthropathy of Knee Joint, run by Manuel Gomez, MD, MSc. at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Arthropathy of Knee Joint
- What is being tested?
- Wii Fit and Lower Extremity Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Outpatients with full lower extremity weight bearing
- Requiring physiotherapy treatment twice weekly for Total Knee Arthroplasty rehabilitation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Arthropathy of Knee Joint
- Being tested
- Wii Fit, Lower Extremity Exercise
- Keywords
- Total knee replacement, Outpatient, Randomized controlled trial, Video games
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii FitOther
Also called Nintendo 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Lower Extremity Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of outpatient rehab stay (LOS)
Days from admission to discharge from the outpatient rehabilitation program
Measured: From admission to discharge, an expected average of 5 weeks.
Secondary outcomes (1)
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.
Measured: From admission to discharge, an expected average of 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMay 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of Knee JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manuel Gomez, MD, MSc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manuel Gomez, MD, MSc., St. John's Rehab Hospital
- Investigators
- Vera Fung, BSc, MSc.PT., Principal investigator, St. John's Rehab Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548664
- Sponsor's protocol ID
- 2009-02
- Status last verified
- Feb 2014
- First submitted
- 5 Mar 2012
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
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.
PubMed 22898573
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization of Nintendo Wii™ in Outpatient Rehabilitation Following Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01548664
- Acronym / sponsor ID
- 2009-02
- Conditions
- Arthropathy of Knee Joint
- Keywords
- Total knee replacement, Outpatient, Randomized controlled trial, Video games
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Manuel Gomez, MD, MSc.University, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintendo Wii FitTM | Experimental | Other: Wii FitFifteen minutes of gaming activity on the Wii Fit™ following each regularly scheduled 60 minute physiotherapy session, in a separate treatment area. |
| Lower extremity exercise | Active comparator | Other: Lower Extremity ExerciseFifteen 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 |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatients with full lower extremity weight bearing
- Requiring physiotherapy treatment twice weekly for Total Knee Arthroplasty rehabilitation.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wii FitAlso: Nintendo Wii Fit15 minutes of gaming activity on the Wii Fit™ following each regularly scheduled 60 minute physiotherapy session, in a separate treatment area. | Other | Nintendo Wii FitTM |
| Lower Extremity ExerciseFifteen 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. | Other | Lower extremity exercise |
Primary outcome
Length of outpatient rehab stay (LOS)
Time frame: From admission to discharge, an expected average of 5 weeks.
Days from admission to discharge from the outpatient rehabilitation program
1 secondary outcome
Lower Extremity Functional Scale
Time frame: From admission to discharge, an expected average of 5 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Results publicationFung 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.
- Derived from this study: PubMed 22898573Fung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Fung, BSc, MSc.PT. principal investigator
St. John's Rehab Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Wii Fit and Lower Extremity Exercise in people with Arthropathy of Knee Joint, run by Manuel Gomez, MD, MSc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of outpatient rehab stay (LOS) (time frame: From admission to discharge, an expected average of 5 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01548664, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.