Back to resultsCast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains
Primary Purpose
Ankle Sprain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Below knee plaster casting
Functional rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Sprain focused on measuring Ankle sprain, Functional rehabilitation, Immobilization
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Immobilization
Functional Rehabilitation
Arm Description
50 patients will be randomly assigned to have their lateral ankle sprain immobilized in a below knee cast
50 patients will be randomly assigned to a functional rehabilitation program for their lateral ankle sprain
Outcomes
Primary Outcome Measures
Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months.
Secondary Outcome Measures
Full Information
NCT ID
NCT01446341
First Posted
August 19, 2011
Last Updated
October 4, 2011
Sponsor
University of British Columbia
Collaborators
Workers' Compensation Board of BC
1. Study Identification
Unique Protocol Identification Number
NCT01446341
Brief Title
Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains
Official Title
A Pilot Study Towards a Randomized Clinical Trial of Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Workers' Compensation Board of BC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
Ankle sprain, Functional rehabilitation, Immobilization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immobilization
Arm Type
Active Comparator
Arm Description
50 patients will be randomly assigned to have their lateral ankle sprain immobilized in a below knee cast
Arm Title
Functional Rehabilitation
Arm Type
Active Comparator
Arm Description
50 patients will be randomly assigned to a functional rehabilitation program for their lateral ankle sprain
Intervention Type
Procedure
Intervention Name(s)
Below knee plaster casting
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Functional rehabilitation
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months.
Time Frame
Measured at 0, 1, and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas Rose, MD, PhD
Phone
604-875-5242
Email
nrose@interchange.ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Rose, MD, PhD
Organizational Affiliation
University of British Columbia - Vancouver Coastal Health Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains
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