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临床试验/NCT01553487
NCT01553487撤回不适用

Effects Of Unilateral Forearm Vibration On The Loss Of Muscle Strength And Bone Of The Contralateral Forearm Due to Forearm/Elbow Fracture

Bagcilar Training and Research Hospital2 个研究点 分布在 2 个国家开始时间: 2013年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Change of forearm muscle strength

研究概览

简要总结

The aim of the present study is to investigate the effects of vibrating the forearm bone in the free limb on muscle strength and bone mineral density of the forearm in patients with forearm/elbow fracture.

A total of 80 patients with forearm/elbow fracture are planned to include in this study. Patients will be randomly attained Training or Control group. Training period will be six weeks. Patients in the control group will receive standard care for provided for fractures, including fixation and rest.Before the start of the study and after six weeks, bilateral bone density of distal radius will be measured by DXA. Before trials, grip strength and the rest muscle electrical activity of contralateral wrist flexors and extensors will be measured. After six weeks, bilateral grip strength and the rest muscle electrical activity will be measured.

详细描述

The structure of a bone and the muscles surrounding it changes in a temporally synchronized fashion. Skeletal muscles have positive effects on bone structure and function. It is well-known that exercise training of muscles improves the resistance of bone to mechanical loading and that physical activity is also important for treating and preventing osteoporosis. Resistance and impact training can induce bone formation and/or prevent bone resorption. Immobilization frequently leads disuse osteoporosis in patients with a bone fracture.

Vibration has a strong osteogenic effect. The cyclic mechanical loading to the bone stimulates osteocytes. Vibration-induced bone formation is neuronally regulated. Vibration can also effectively enhance muscle strength and power. Previous studies have shown that vibration increases muscle electromyographic (EMG) activity. Based on the bone myoregulation reflex, bone is sensitive to mechanical stimuli and can send mechanical input signals to central nervous system and so can neuronally regulate the muscle activity.

Previous studies have documented the impact of unilateral training of limb muscle on the untrained contralateral homologous muscle.

The aim of the present study is to investigate the effects of vibrating the forearm bone in the free limb on muscle strength and bone mineral density of the forearm in patients with forearm/elbow fracture.

The study will include a total of 80 patients with forearm/elbow fractures. The participants meeting inclusion criteria will be randomized into one of two groups: a training group (40 cases) and a control group (40 cases). Patients in the control group will receive standard care for provided for fractures, including fixation and rest.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a simple (uncomplicated) forearm/elbow fracture
  • Males and females between 18 and 50 years of age

排除标准

  • Fracture of distal radius
  • Multiple previous fractures of bones in the upper extremities
  • Complicated fracture (associated skin and/or tendon and/or nerve and/or vascular trauma, fragmented fractures )
  • Patients not examined within the first three days after a trauma
  • Upper extremity problems
  • Orthopedic problems: shortness of arms, congenital abnormalities
  • Joint disease (arthritis, joint prosthesis, etc.)
  • Other painful pathologies in the upper extremities (tendinitis, bursitis, etc.)
  • Circulation problems in the upper extremities
  • Skin lesions, dermatologic disorders
  • Hypertension (>135 mmHg systolic, >85 mmHg diastolic) or Heart disease (coronary dis, conduction/rhythm prob, cardiac pacemaker)
  • Neurological diseases (CNS problems, peripheral neuropathy)
  • Systemic disease affecting bone metabolism: secondary osteoporosis, osteomalacia, Paget's disease, Diabetes mellitus, hepatic disease, renal dis. etc
  • Non-cooperative patients, psychiatric conditions (panic attacks etc)

研究组 & 干预措施

Excercise

Experimental

The forearm vibration training

干预措施: Forearm vibration (Other)

Control

No Intervention

Patients will be treated by routine fracture treatment methods (fixation and rest).

结局指标

主要结局

Change of forearm muscle strength

时间窗: baseline and 6 weeks

Change of muscle strength with forearm vibration

次要结局

  • Change of distal radius bone mineral density(baseline and 6 weeks)

研究者

发起方
Bagcilar Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ilhan Karacan, Clinical Associated Professor

Clinical Associated Professor

Bagcilar Training and Research Hospital

研究点 (2)

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