Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains

Study Overview
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Brief Summary
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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.

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

Conditions
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Ankle Sprain

Intervention / Treatment
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* Procedure: Below knee plaster casting
* Procedure: Functional rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 meet clinical criteria for unilateral grade II-III ankle sprains (inability to weight bear) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immobilization<br>50 patients will be randomly assigned to have their lateral ankle sprain immobilized in a below knee cast | Procedure: Below knee plaster casting<br>* Subjects will be randomly assigned to either immobilization of their lateral ankle sprain with a below knee cast or to enter a functional rehabilitation program<br>|
| Active Comparator: Functional Rehabilitation<br>50 patients will be randomly assigned to a functional rehabilitation program for their lateral ankle sprain | Procedure: Functional rehabilitation<br>* Subjects will be randomly assigned to either immobilization of their lateral ankle sprain with a below knee cast or to enter a functional rehabilitation program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months. |  | Measured at 0, 1, and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle sprain, Functional rehabilitation, Immobilization