A Pilot Study Towards a Randomized Clinical Trial of Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains
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
- 是
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
研究组 & 干预措施
Immobilization
50 patients will be randomly assigned to have their lateral ankle sprain immobilized in a below knee cast
干预措施: Below knee plaster casting (Procedure)
Functional Rehabilitation
50 patients will be randomly assigned to a functional rehabilitation program for their lateral ankle sprain
干预措施: Functional rehabilitation (Procedure)
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
