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临床试验/NCT01548664
NCT01548664已完成2 期

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

Manuel Gomez, MD, MSc.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年5月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Length of outpatient rehab stay (LOS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Length of outpatient rehab stay (LOS)

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

Days from admission to discharge from the outpatient rehabilitation program

次要结局

  • Lower Extremity Functional Scale(From admission to discharge, an expected average of 5 weeks.)

研究者

发起方
Manuel Gomez, MD, MSc.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Manuel Gomez, MD, MSc.

Director of the Clinical Research Department

St. John's Rehab Hospital

研究点 (2)

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