Rehabilitation of Patients With Total Knee Replacement Through the Immersive Virtual Reality in Aquatic Scenarios
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Changes in Time Up & Go Test
研究概览
简要总结
This study is a multicenter non-randomized single-blind controlled trial, aimed at investigating the feasibility and efficacy of hydrotherapy based on IVR, for the patients with TKR(Total Knee Replacement), on the function, gait performance, postural balance control, and knee edema reduction. The protocol was draft according to the Consolidated Standards of Reporting Trials (CONSORT ) checklists.
A total of 96patients with total knee prosthesis will be recruited and divided into three groups, to receive a traditional rehabilitation (TR) program, traditional hydrotherapy (TH)or hydrotherapy through immersive virtual reality (HIVR) using Bts-Nirvana. Assessments will be performed at baseline and at the end of treatment.
详细描述
For the study, inpatients will be taken into consideration. A maximum of 17 treatment sessions will be conducted, divided from 3 to 5 training sessions per week. The treatments will be carried out in groups consisting of 3 patients.
All patients included in the study will perform 45 minutes of traditional rehabilitation treatments, consisted in:
- passive mobilization for the recovery of the complete articular range;
- active work on cycle ergometer;
- muscle strengthening with isometric and isotonic exercises;
- proprioceptive exercises in standing position for load balancing and balance control;
- step training with progressive reduction of walking aids;
- recovery of autonomy in the ascent and descent from the stairs;
- recovery of autonomy in daily life activities. In addition to this common program, specific knee therapy will be performed as provided in the three groups.
Traditional Rehabilitation (TR): the TR group exercises will be performed in the gym with a physiotherapist. In particular, patients will perform:
- exercises with a patient sitting on a chair (3 minutes per exercise):
- flexion-extension of the knee;
- leg and hip circling;
- flexion-extension of the ankle;
- triple flexion;
- walking (with and without aids).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
The care providers are not aware about the research study protocol.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria are:
- •Aged ≤ 85;
- •Capacity to consent and to perform the exercises of the specific protocol;
- •Patients with total knee prosthesis.
排除标准
- •Failure to meet the inclusion criteria;
- •Concomitant participation in other studies;
- •Unicompartmental knee prostheses;
- •Surgery without drainage;
- •Wound complications;
- •Cognitive disorders;
- •Diagnosis of epilepsy;
- •Lack of written informed consent;
结局指标
主要结局
Changes in Time Up & Go Test
时间窗: At baseline (day 1-T1) and at the end (day 21 -T2) of the treatment.
Time Up and Go test (TUG): TUG is a test used to determine fall risk and measure the progress of balance, sit to stand and walking. The patient starts in a seated position, then stands up, walks 3 meters, turns around, walks back to the chair and sits down. If a patient took 14 seconds or longer to perform the test he was classified as high-risk for falling
次要结局
- Change in 10-Metre Walking Test (10MWT)(At baseline (day 1-T1) and at the end (day 21 -T2) of the treatment.)