跳至主要内容
临床试验/NCT03717727
NCT03717727已完成不适用

Effectiveness of Gamification in Knee Replacement Rehabilitation. Randomized Controlled Trial and Qualitative Approach

University of Jyvaskyla4 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年11月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
4
主要终点
Change in Function and pain related to knee

研究概览

简要总结

After total knee arthroplasty (TKA), knee is usually swollen, painful, and stiff. The main goal of post-operative physical rehabilitation is to achieve full extension and flexion of the knee to avoid contractures and stiffness. Also strengthening of quadriceps muscle and balance to help activities of daily living and overall mobility are important. The post-operative knee replacement rehabilitation includes the standard protocol in hospital phase and the standard home exercise instructions. Computer based exercising games (exergames) may be new method to increase training adherence and volume after TKA and thus improve results and effectiveness of the rehabilitation. However, evidence of effectiveness of rehabilitative exergaming on physical functioning is sparse and more research is needed to conduct evidence-based rehabilitation practices.

Therefore the present study examines the effectiveness of a 16-week gamified physiotherapy on physical functioning, life satisfaction and pain for patients after TKA compared to treatment as usual home exercise. The second objective is to validate the psychometric properties of WHODAS 2.0 (WHO Disability Assessment Schedule) and brief ICF (International classification of functioning, disability and health) core set of osteoarthritis questionnaire. Other objectives are to find out, what kind of understanding and experiences the participants have about the rehabilitation with exergames and to evaluate the usability and user experience of exergames.

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
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •first primary (M17.0, M17.1) unilateral TKA
  • •mechanical axis of the limb in varus
  • •model of the TKA is posterior stabilizing (PS) or cruciate retaining (CR) prosthesis
  • •normal vision with or without eyeglasses

排除标准

  • •fractures, rheumatoid arthritis, or other biomechanical disruptions in affected lower limb within one year before operation
  • •diagnosed memory disorder or cognitive impairment
  • •neurological condition as Parkinson's disease, multiple sclerosis or stroke

研究组 & 干预措施

Exergame

Experimental

Home-based exergame intervention and usual treatment.

干预措施: Exergame (Other)

Control

Experimental

Home-exercise by standard protocol and usual treatment.

干预措施: Control (Other)

结局指标

主要结局

Change in Function and pain related to knee

时间窗: Change from pre-operative baseline at 2 and 4 months post-operative.

Oxford Knee Score

Change in Mobility

时间窗: Change from pre-operative baseline at 2 and 4 months post-operative.

Timed Up and Go

次要结局

  • Change in Disability(pre-operative baseline and 2, 4 and 12 months post-operative)
  • Change in other symptoms such as swelling, restricted range of motion and mechanical symptoms(pre-operative baseline and 2, 4 and 12 months post-operative)
  • Change in activities of daily living (ADL) Function(pre-operative baseline and 2, 4 and 12 months post-operative)
  • Change in Function and pain related to knee(Change from pre-operative baseline at 12 months post-operative.)
  • Change in Walking(pre-operative baseline and 2, 4 and 12 months post-operative)
  • Change in Lower extremity performance(pre-operative baseline and 2, 4 and 12 months post-operative)
  • Change in Pain(pre-operative baseline and 2, 4 and 12 months post-operative)
  • Change in quality of life (QOL)(pre-operative baseline and 2, 4 and 12 months post-operative)
  • Change in Muscle strength(pre-operative baseline and 2, 4 and 12 months post-operative)
  • Change in Knee range of motion(pre-operative baseline and 2, 4 and 12 months post-operative)
  • Change in Mobility(Change from pre-operative baseline at 12 months post-operative.)
  • Change in knee pain (VAS)(pre-operative baseline and 2, 4 and 12 months post-operative)
  • Change in Sport and Recreation Function(pre-operative baseline and 2, 4 and 12 months post-operative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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