Ankle SprainNCT01446341
Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains
A study testing Below knee plaster casting and Functional rehabilitation in people with Ankle Sprain, run by University of British Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Below knee plaster casting and Functional rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age over 18
- meet clinical criteria for unilateral grade II-III ankle sprains (inability to weight bear)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot Study Towards a Randomized Clinical Trial of Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains
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
- Being tested
- Below knee plaster casting, Functional rehabilitation
- Keywords
- Ankle sprain, Functional rehabilitation, Immobilization
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Below knee plaster castingProcedure or surgery
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
Functional rehabilitationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Immobilization | Active comparator | 50 patients will be randomly assigned to have their lateral ankle sprain immobilized in a below knee cast Receives: Procedure: Below knee plaster casting |
| Functional Rehabilitation | Active comparator | 50 patients will be randomly assigned to a functional rehabilitation program for their lateral ankle sprain Receives: Procedure: Functional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months.
Measured: Measured at 0, 1, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Workers' Compensation Board of BC
- Responsible party
- Sponsor
- Investigators
- Nicholas Rose, MD, PhD, Principal investigator, University of British Columbia - Vancouver Coastal Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446341
- Sponsor's protocol ID
- H11-01150
- Status last verified
- Oct 2011
- First submitted
- 19 Aug 2011
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Towards a Randomized Clinical Trial of Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains
- ClinicalTrials.gov ID
- NCT01446341
- Acronym / sponsor ID
- H11-01150
- Conditions
- Ankle Sprain
- Keywords
- Ankle sprain, Functional rehabilitation, Immobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Workers' Compensation Board of BC
- Study start
- Nov 2011
- Primary completion
- May 2012 (estimated)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immobilization | Active comparator | Procedure: Below knee plaster casting50 patients will be randomly assigned to have their lateral ankle sprain immobilized in a below knee cast |
| Functional Rehabilitation | Active comparator | Procedure: Functional rehabilitation50 patients will be randomly assigned to a functional rehabilitation program for their lateral ankle sprain |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age over 18
- meet clinical criteria for unilateral grade II-III ankle sprains (inability to weight bear)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Below knee plaster castingSubjects 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 or surgery | Immobilization |
| Functional rehabilitationSubjects 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 or surgery | Functional Rehabilitation |
Primary outcome
Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months.
Time frame: Measured at 0, 1, and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Rose, MD, PhD principal investigator
University of British Columbia - Vancouver Coastal Health Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Below knee plaster casting and Functional rehabilitation in people with Ankle Sprain, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Rose, MD, PhD (604-875-5242, nrose@interchange.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months. (time frame: Measured at 0, 1, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2011.