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临床试验/NCT01702597
NCT01702597Unknown不适用

The Effect of Whole Body Vibration and Acute Unilateral Unstable Lateral Ankle Sprain - A Biphasic Randomized Controlled Trial -

Ludwig-Maximilians - University of Munich0 个研究点目标入组 60 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Postural control

研究概览

简要总结

The aim of this bicentric, biphasic, randomized, controlled study is to compare of the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains over a period of 12 months

详细描述

Background:

Ankle sprains often result in ankle instability, which is most likely caused by damage to passive and neurological structures. Whole body vibration (WBV) is a neuromuscular training method improving those neurologic parameters impaired. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains.

Methods/Design:

60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Patients will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-depending weight bearing, limited functional immobilization by orthesis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, 30 minutes per session, for 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform similar exercises on a side-alternating sinusoidal vibration platform as the control group. Two time dependent primary outcome parameters will be assessed. Short-term outcome after six weeks will be postural control quantified by the sway index. Mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include return to pre-injury level of activities, residual pain, recurrence, objective instability, energy / coordination, Foot and Ankle Disability Index and EQ 5D.

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

入选标准

  • Acute, unilateral, unstable, inversion ankle sprain (Grade II, III)

排除标准

  • Pregnancy
  • Conditions affecting the neuromuscular- or musculoskeletal System
  • Previous surgical interventions to the foot, ankle, knee or hip; known FAI, CAI
  • Conditions possibly affecting balance
  • Cardiovascular disease including thrombosis
  • Respiratory diseases
  • Abdominal diseases (including gallstones)
  • Urological diseases (including kidney- and bladder stones)
  • Gynaecological diseases and + intrauterine devices
  • Neurological diseases including epilepsia within the last 2 years
  • Acute injuries to the head
  • Patient is not available for follow up visits
  • Patient unable to give informed consent
  • Patient suspected to be non-compliant

结局指标

主要结局

Postural control

时间窗: 6 weeks

Sway Index measured via the Leonardo Mechanograph GRFP (16 bit, 800 Hz; NOVOTEC Medical GmbH, Germany)

次要结局

  • Subjective instability(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sebastian. F. Baumbach

Principle Investigator

Ludwig-Maximilians - University of Munich

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