Evaluation of the Efficacy of the ALLYANE Procedure in the Treatment of Central Motor Inhibition Immediately After Knee Sprain As an Adjunct to Conventional Treatment.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Muscle activity
研究概览
简要总结
The goal of this clinical study is to determine the effectiveness of restoring muscle strength in the management of motor inhibition when complemented by the ALLYANE process (neuro-motor reprogramming) compared to a standard management approach.
The main questions it aims to answer are:
- Does the ALLYANE process lead to greater muscle strength gains compared to standard care?
- Is there a functional benefit when standard management is complemented by the ALLYANE process?
The investigators will compare the group receiving standard care complemented by ALLYANE to a group receiving only standard care to evaluate if the ALLYANE process provides additional effects.
Participants will:
- Undergo assessments of muscle strength.
- Receive either standard management or standard management with ALLYANE.
- Complete functional evaluations before and after treatment.
详细描述
This study aims to evaluate the effectiveness of motor inhibition management using two different approaches: standard management alone and standard management supplemented by the ALLYANE neuro-motor reprogramming process. To ensure robust and reliable results, the study proposes enrolling a total of 120 patients, divided into two groups of 60 patients each.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 35 years
- •No neurological history
- •Have had a primary knee sprain
- •Present with VMO lateralisation with or without the presence of flessum
- •Quadricipital weakness between the healthy and injured limb of 50% or more as measured by a portable dynamometer
- •Member of a social security scheme
排除标准
- •Recurrent sprain
- •Bilateral sprain
- •Persons under guardianship, trusteeship or any other measure depriving them of their rights or liberty, and adults protected by law.
- •Persons who do not understand French
- •Knee trauma other than sprain
- •Exclusion criteria for the Allyane procedure (COPHOSIS, cognitive difficulties, purely mechanical limitation)
- •Algodystrophy
结局指标
主要结局
Muscle activity
时间窗: Before and 3 weeks after conventional therapy
Electromyography (EMG) during maximal voluntary isometric contraction of leg extension.
次要结局
- Strength(Before and 3 weeks after conventional therapy)