Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Thuasne
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Comparison of the functional proprioceptive capacity of the knee in patients with proprioceptive deficit with or without wearing an elastic proprioceptive knee brace.
研究概览
简要总结
The objective of the study is to compare, with or without wearing an elastic proprioceptive knee brace, the functional proprioceptive capacity of the knee in patients suffering from proprioceptive deficit.
详细描述
This proprioceptive deficit is found following various traumas or injuries such as Anterior Cruciate Ligament (ACL) rupture, for example.
The use of joint stabilizers (such as knee braces) will allow an increase in sensory input (particularly at the level of cutaneous mechanoreceptors), and improve the biomechanics of the injured joint.
The objective of the study is to compare, with or without wearing an elastic proprioceptive knee brace, the functional proprioceptive capacity of the knee in patients suffering from proprioceptive deficit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
the clinical trial is carried out in open label
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a proprioception deficit of the knee: detection threshold higher than 2.5° on the TTDPM (Threshold to detect passive motion) test
- •Patient whose knee measurements are compatible with the sizes of the proprioceptive knee brace
- •Patient having signed a free and informed consent form
- •Patient affiliated or entitled to a social security plan
排除标准
- •Patient with knee pain on walking greater than or equal to 4 out of 10 on a VAS scale.
- •Patient in the early phase of acute trauma to the lower limb
- •Patient having worn a knee brace in the 48 hours prior to inclusion
- •Pregnant women
- •Patient presenting one of the contraindications to the use of the knee brace, indicated in the instructions for use
- •Patient with a major cognitive impairment incompatible with participation in a clinical trial
- •Patient participating in another clinical investigation conducted to establish the conformity of a DM (Medical Device) impacting the judgment criteria
- •Vulnerable patient according to article L1121-6 of the public health code, person subject to a judicial protection measure or unable to consent freely
结局指标
主要结局
Comparison of the functional proprioceptive capacity of the knee in patients with proprioceptive deficit with or without wearing an elastic proprioceptive knee brace.
时间窗: Day 1 (2 times, after condition 1 and after condition 2)
The functional proprioceptive capacity of the knee is measured via the 3-axis composite score of the Y Balance Test (YBT). This score corresponds to the average of the 3 maximum distances obtained during the YBT test, normalized by leg length.
次要结局
- Evaluation of patient satisfaction with the use of the knee brace with a specific questionnaire(Day 1)
- Evaluation of the discomfort level when using or not the knee brace.(Day 1 (2 times, after condition 1 and after condition 2))
- Evaluation of tactile sensitivity (baresthesia) with or without wearing the knee brace(Day 1 (2 times, after condition 1 and after condition 2))
- Evaluation of the sensitivity to the position of a joint with or without wearing the knee brace(Day 1 (2 times, after condition 1 and after condition 2))
- Evaluation of the range of motion ok the knee level when using or not the knee brace.(Day 1 (2 times, after condition 1 and after condition 2))
- Evaluation of the static stability when using or not the knee brace.(Day 1 (2 times, after condition 1 and after condition 2))
- Evaluation of the stability when walking when using or not the knee brace.(Day 1 (2 times, after condition 1 and after condition 2))
- Evaluation of the fluidity level when using or not the knee brace.(Day 1 (2 times, after condition 1 and after condition 2))
- Evaluation of the patient's tolerance to the use of the knee brace.(Day 1)