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
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedOctober 5, 2011
October 1, 2011
6 months
August 19, 2011
October 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months.
Measured at 0, 1, and 3 months
Study Arms (2)
Immobilization
ACTIVE COMPARATOR50 patients will be randomly assigned to have their lateral ankle sprain immobilized in a below knee cast
Functional Rehabilitation
ACTIVE COMPARATOR50 patients will be randomly assigned to a functional rehabilitation program for their lateral ankle sprain
Interventions
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
Eligibility Criteria
You may qualify if:
- age over 18
- meet clinical criteria for unilateral grade II-III ankle sprains (inability to weight bear)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Workers' Compensation Board of BCcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicholas Rose, MD, PhD
University of British Columbia - Vancouver Coastal Health Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2011
First Posted
October 5, 2011
Study Start
November 1, 2011
Primary Completion
May 1, 2012
Last Updated
October 5, 2011
Record last verified: 2011-10