NCT00312793终止1 期
Phase 2 Study to Evaluate the Efficacy and Safety of Electronic Stimulation of the Quadriceps Muscle in the Thigh by the MyoSpare Device, in Patients Who Underwent Reconstruction of the Anterior Cruciate Ligament (ACL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of Myospare, a non-invasive device, which is connected to the body via electrodes placed in the injured leg. The electrodes which are placed in the middle or upper thigh will stimulate the quadriceps muscle.
Myospare will be installed 1 day after the anterior cruciate ligament (ACL) reconstruction surgery and will be removed after 6 weeks of treatment. The patients will be assigned to two groups:
- Physiotherapy plus Myospare
- Only physiotherapy
The hypothesis of the study is that electrical stimulation combined with voluntary exercise is more effective than voluntary exercise alone.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 18-40 years old.
- •Subjects who are planning to undergo ACL surgery.
- •The surgery is performed within 3 weeks - 5 years since the injury.
- •Ability to follow instructions during the study period.
- •Signed Informed Consent.
排除标准
- •Bi-lateral surgery of the knee
- •Recurrent ACL surgery (patients who already underwent ACL surgery)
- •Complex injuries (a combination of posterior and anterior cruciate and lateral ligament injury)
- •Patients who underwent or are planned to undergo cartilage implantation.
- •Patients who underwent or are planned to undergo meniscus stitching.
- •Additional fracture/s in the lower limbs as a result of the same injury.
- •Signs of infection in the surgical wounds while installing the Myospare device.
- •Known skin hypersensitivity.
- •Known heart disease
- •Patients with a cardiac pacemaker.
- •History of peripheral blood vessel disease
- •Administration of drugs which might disrupt bone metabolism:
- •Total accumulating dosage of 150 gr' prednisone or any other glucocorticoid for seven days or more, within 6 months prior to the trial.
- •Calcitonin for 7 days or more, within 6 months prior to the trial.
- •Bisphosphonates for 30 days or more within 12 months prior to the study.
- •Fluoride for bone strengthening for 30 days or more within 12 months prior to the study.
- •Vitamin D or vitamin D metabolite for bone strengthening for 30 days or more within 12 months prior to the study.
- •Current treatment with chemotherapeutic drugs.
- •Past or current malignant disease within 10 years of study entry.
- •Participating in another clinical study during the past four weeks.
- •Patients who are planned to undergo femoral nerve block.
- •Patients claiming social security/work accident benefits.
- •Professional athletes whose livelihood depends on sports.
- •Pregnant and or lactating women.
- •Additional symptoms, which in the doctor's opinion would prevent inclusion of the patient in the study.
结局指标
主要结局
the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device
次要结局
- range of movement measured by protractor
- swelling measure by physical examination
- stability of the knee measure by KT1000
- knee history measure by IKDC2000
- functional preservation measure by single hop tests and triple hop tests
研究者
研究点 (3)
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