NCT04159623已完成不适用
Clinical Applicability of the Device Belk in the Rehabilitation Process
Basque Health Service1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年11月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of sessions until recovery
研究概览
简要总结
Pilot, interventional, randomized of parallel groups and multicenter clinical trial.
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
- None
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
- •Patients of both sexes.
- •Patients aged between 18 and 85 years.
- •Patients with knee arthroplasty in the immediate postoperative period.
- •Sign in informed consent.
排除标准
- •Physical or psychological pathologies that prevent patient participation.
- •Tumor arthroplasty.
- •Knee replacement prosthesis.
- •Impossibility of holding the device.
- •Patients with a pacemaker.
研究组 & 干预措施
Belk Device
Experimental
With Belk Device
干预措施: Belk Device (Device)
Standard Rehabilitative treatment
Other
With the standard rehabilitative treatment
干预措施: Standard Rehabilitative treatment (Other)
结局指标
主要结局
Number of sessions until recovery
时间窗: An average of 12 weeks
It is considered that the patient has completed the rehabilitation treatment when he has achieved an arc of movement between 0 and 100 degrees of flexion, a quadriceps muscle balance greater than or equal to 4/5 according to MRC (Medical Research Council)and a stable march with crutches.
次要结局
- March in 10 meters(An average of 12 weeks)
- Number of falls during rehabilitation sessions(An average of 12 weeks)
- UP&Go test(An average of 12 weeks)
研究者
Juan Andrés Álava
Principal Investigator
Basque Health Service
研究点 (1)
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