Effect of Proprioceptive Knee Braces on the Performance and Endurance of Recreational Soccer Players Aged 60-80 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Thuasne
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Evaluate the effect of bilateral proprioceptive knee braces on the endurance of subjects compared to without knee brace.
研究概览
简要总结
The objective of the study is to evaluate the effect of wearing bilateral proprioceptive knee braces on the endurance of subjects aged 60 to 80 years.
详细描述
Sporting activity has proven health benefits, particularly for older adults, whose balance and neuromuscular functions decline with age.
On the other hand, physical activity in the elderly population may be hampered by inadequate physical condition, muscle or proprioceptive deficits, or fear of falling or injuring. A proprioceptive knee brace could therefore make physical activity safer and thus improve performance, balance, and ultimately the quality of life of the participants.
The objective of the study is to evaluate the effect of wearing bilateral proprioceptive knee braces on the endurance of subjects aged 60 to 80 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
the clinical trial is carried out in open label
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject practicing recreational soccer
- •Subject included in the LIBM (inter-university laboratory of motor biology) study: "Effect of recreational soccer practice in persons aged 60 to 80 years"
- •Patient whose knee measurements are compatible with the knee brace sizes
- •Patient who has signed a free and informed consent form
- •Patient affiliated or entitled to a social security plan
排除标准
- •Patients with any of the contraindications to the use of the knee brace, as 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 device impacting the judgment criteria
- •Vulnerable patient according to article L1121-6 of the public health code, person subject to a legal protection measure or unable to consent freely
结局指标
主要结局
Evaluate the effect of bilateral proprioceptive knee braces on the endurance of subjects compared to without knee brace.
时间窗: week 1
The evaluation of the subjects' endurance corresponds to the difference in results obtained during the 6-minutes walk test in the absence and presence of knee braces.
次要结局
- Evaluate the impact of knee braces on balance compared to without knee brace.(week 1)
- Evaluate the impact of knee braces on lower limb strength compared to without knee brace.(week 1)
- Evaluate the impact of knee braces on walking speed compared to without knee brace.(week 1)
- Evaluate the impact of knee braces on the volunteer's feelings about the stability of his knees, their range of motion, his confidence when walking and his fear of falling after the tests and after the training(week 1, week 2)
- Evaluate the influence of the functional capacity of the knees of each volunteer at inclusion on the various performance parameters measured(Day 0)
- Evaluate the satisfaction of the volunteers with the device(Last visit)
- Evaluate the tolerance of the knee braces(week 1, week 2)