Effects of Virtual Reality Rehabilitation in Patients With Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Time Up and Go (TUG)
研究概览
简要总结
Impaired proprioceptive accuracy could be a risk factor for progression of gait limitations in knee osteoarthritis patients, even after the Total Knee Replacement (TKR). Recent studies on Virtual Reality (VR) in rehabilitation show its efficacy in restoring proprioceptive capacity, postural control and gait. However, literature lacks such studies in TKR patients. This preliminary study aims to evaluate the efficacy of a VR system for the enhancement of motor skills in TKR patients compared to a traditional approach of rehabilitation.
详细描述
In this randomized controlled trial (RCT), the randomization of the sample will be performed by a local software and in a single blind design. Forty patients will be enrolled and after giving the informed consent, assigned to two groups :
- the experimental group (VRG), which will be undergone to treatment with virtual reality for the recovery of load distribution and proper gait pattern;
- the control group (CG), which will be undergone to a traditional rehabilitation addressed to recovery of correct gait pattern for the same time period as VRG.
Both treatments consist in 15 sessions, at least 5 per week , each lasting 45 minutes. Both VRG or CG will last for 21 days from the start of treatment.
All patients, in adjunction to Virtual Reality Rehabilitation (EG) or Traditional Rehabilitation (CG), will execute a global rehabilitation project, consisting in Physiotherapy, Physical Therapies for pain and inflammation control, and Occupational Therapy, personalized by a multidisciplinary rehabilitation team for a minimum of 150-180 minutes per day, and according to their clinical conditions for them.
The purposes of this study in detail are:
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recruitment and initial assessment within 10 days of surgery;
- •monolateral knee arthroplasty in election;
- •collaborating patients who are able to perform the proposed exercise;
- •good cardiovascular compensation;
- •cognitively intact;
- •able to provide informed consent;
排除标准
- •no severe cognitive / behavioral deficit;
- •refusal or inability to provide informed consent;
- •presence of sever cardiorespiratory co-morbidities;
- •peripheral and /or central neurological deficits;
- •visual deficits;
- •presence of serious osteo-arthro-muscular diseases at controlateral lower limb against the prosthetic side;
- •complication at surgical wound
结局指标
主要结局
Change in Time Up and Go (TUG)
时间窗: Session 1 (baseline) and session 15 (day 21)
The TUG is a timed test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leaned up against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.
次要结局
- Change in Barthel Index (BI)(Session 1 (baseline) and session 15 (day 21))
- Change in 10 Meter Walk Test (10-MWT)(Session 1 (baseline) and session 15 (day 21))
- Change in Medical Research Council scale (MRC)(Session 1 (baseline) and session 15 (day 21))
- Change in Visual Analog Scale (VAS)(Session 1 (baseline) and session 15 (day 21))
- MiniMental State evaluation (MMSE)(Session 1 (baseline))