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

NCT01446341 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-10-05

No results posted yet for this study

Summary

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.

Conditions

  • Ankle Sprain

Interventions

PROCEDURE

Below knee plaster casting

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

PROCEDURE

Functional rehabilitation

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

Sponsors & Collaborators

  • Workers' Compensation Board of BC

    collaborator UNKNOWN
  • University of British Columbia

    lead OTHER

Principal Investigators

  • Nicholas Rose, MD, PhD · University of British Columbia - Vancouver Coastal Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01446341 on ClinicalTrials.gov