MedDataX Logo

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

NCT ID: NCT01446341

Last Updated: 2011-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ankle Sprain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Immobilization

50 patients will be randomly assigned to have their lateral ankle sprain immobilized in a below knee cast

Group Type ACTIVE_COMPARATOR

Below knee plaster casting

Intervention Type PROCEDURE

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 Rehabilitation

50 patients will be randomly assigned to a functional rehabilitation program for their lateral ankle sprain

Group Type ACTIVE_COMPARATOR

Functional rehabilitation

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Below 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

Intervention Type PROCEDURE

Functional rehabilitation

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of British Columbia

OTHER

Sponsor Role lead

Workers' Compensation Board of BC

UNKNOWN

Sponsor Role collaborator

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nicholas Rose, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia - Vancouver Coastal Health Research Institute

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nicholas Rose, MD, PhD

Role: CONTACT

[email protected]
604-875-5242

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H11-01150

Identifier Type: -

Identifier Source: org_study_id