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Cast 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
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain focused on measuring Ankle sprain, Functional rehabilitation, Immobilization

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 19, 2011
    Last Updated
    October 4, 2011
    Sponsor
    University of British Columbia
    Collaborators
    Workers' Compensation Board of BC
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    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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