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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01446341
Enrollment
100
Registered
2011-10-05
Start date
2011-11-30
Completion date
Unknown
Last updated
2011-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprain

Keywords

Ankle sprain, Functional rehabilitation, Immobilization

Brief 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.

Interventions

PROCEDUREBelow 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

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

Workers' Compensation Board of BC
CollaboratorUNKNOWN
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months.Measured at 0, 1, and 3 months

Contacts

Primary ContactNicholas Rose, MD, PhD
nrose@interchange.ubc.ca604-875-5242

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026