跳至主要内容
临床试验/NCT01446341
NCT01446341Unknown不适用

A Pilot Study Towards a Randomized Clinical Trial of Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains

University of British Columbia0 个研究点目标入组 100 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months.

研究概览

简要总结

Acute, severe lateral ankle sprains are estimated to comprise between 3-5% of emergency department visits and are the most common musculoskeletal injury in the physically active population. Although the current accepted treatment of ankle sprains is to encourage early mobilization with functional rehabilitation, there is little high-quality evidence directing this clinical practice.

This pilot study is to:

  • provide quantitative data for estimation of mean outcome scores and standard deviations to allow subsequent sample size calculations
  • evaluate the feasibility of the proposed study design
  • assess patient enrollment issues specific to randomization into an active rehabilitation program compared to below knee immobilization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18
  • meet clinical criteria for unilateral grade II-III ankle sprains (inability to weight bear)

排除标准

  • bony injury on x-ray or computed tomography
  • contraindications to recurrent icing
  • high risk of deep-vein thrombosis
  • injury greater than 3 days old
  • ongoing recovery from previous acute ankle sprain
  • age greater than 60
  • non-English speaking patients, those patients unable to provide informed consent or patients with insufficient contact information for follow-up

结局指标

主要结局

Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months.

时间窗: Measured at 0, 1, and 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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