Personalized Rehabilitation Strategies According to Muscle Volume Before Knee Arthroplasty: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Difference of isometric strength D0-W4p
研究概览
简要总结
Preoperative rehabilitation before total knee arthroplasty (TKA) has not been proven to be effective. Latest meta-analyzes do not find any improvement of motor performance during gait 6 months after surgery. However, most of the previous studies did not specifically target muscle atrophy to design rehabilitation protocol. Pre-operative muscle atrophy, although not systematic, is often observed. The preoperative muscles volumes of thigh muscles have been poorly identified and never used to adjust the pre operative rehabilitation strategy.
As part of the "FOLLOWKNEE" (RHU) project, which attempts to implement a personalized management of TKA and its follow-up, this study wants to explore the potential effect of adapted treatment to improve muscle force and muscle volume before TKA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Terminal stage gonarthrosis with total knee arthroplasty (TKA) indication
- •TKA indicated by the surgeon
- •Body Mass Index < 35
- •Acceptance to realize a preoperative rehabilitation in outpatient setting
- •Adult between 18 and 80 years old
- •Patient affiliated to social security
- •Patient who signed an informed consent
排除标准
- •Functionally uncomfortable osteoarticular illness (disabling pain, functional limitation of joint amplitudes or muscle strength) of controlateral leg.
- •Unable or refusal to consent
- •Contraindication to electrostimulation (skin lesion, nearby implanted metallic material, implanted cardiac or neurologic electrostimulator, intolerance to muscle electrical stimulation)
- •Unstable medical situation preventing the continuous realization of a program of at least 4 weeks
结局指标
主要结局
Difference of isometric strength D0-W4p
时间窗: Day 0 to Week 4 postoperative
Isometric strength of quadriceps (QS) and hamstring (HS) will be measured on isokinetic bench and the difference between D0 and W4 will be calculated as follows : (QSW4p-QSD0)+(HSW4p-HSD0). Personalized rehabilitation will first be compared to classic rehabilitation and if positive to global rehabilitation.
次要结局
- Time up and go test (TUG)(Day 0, Week 4, Week 4 postoperative, Week 12 postoperative)
- Western Ontario McMaster Osteoarthritis Index (WOMAC)(Day 0, Week 4, Week 4 postoperative, Week 12 postoperative)
- Difference of isometric strength D0-W12p(Day 0 to Week 12 postoperative)
- Walking speed on 10 meters(Day 0, Week 4, Week 4 postoperative, Week 12 postoperative)
- Pain in Analogic Visual Scale (AVS)(Day 0, Week 4, Week 4 postoperative, Week 12 postoperative)
- Muscles volumes(Day 0, Week 4, Week 2 postoperative)
- Difference of isometric strength D0-W4(Day 0 to Week 4)