- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01405274
Impact of Physiotherapy Intervention for Children With Ankle Sprains
April 2, 2019 updated by: Isabelle Gagnon, McGill University Health Centre/Research Institute of the McGill University Health Centre
Exploring the Impact of a Physiotherapy Intervention on the Risk of Re-injury and Recovery in Children and Adolescents With Acute Ankle Sprains: a Randomized Controlled Trial
This study will investigate whether adding a physiotherapy intervention to standard Emergency Department care will lead to improved recovery following an ankle sprain in the pediatric and adolescent population as well as to a decrease recurrence of injuries during the year following the initial ankle sprain.
Children will be allocated to standard care or to the added intervention group.
The study hypothesis is that recovery will be better while recurrence of injury will be less in those receiving the added physiotherapy intervention.
Study Overview
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3H 1P3
- MUHC-Montreal Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 7 to 18
- confirmed diagnosis of ankle sprain
- Ability to Speak French or English
Exclusion Criteria:
- immobilization at the time of ED discharge
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: standard care
|
|
Experimental: Physiotherapy intervention
|
Physiotherapy treatment bi-weekly, delivered at the child's home
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
recurrence of ankle sprain
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
July 28, 2011
First Submitted That Met QC Criteria
July 28, 2011
First Posted (Estimate)
July 29, 2011
Study Record Updates
Last Update Posted (Actual)
April 4, 2019
Last Update Submitted That Met QC Criteria
April 2, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-287-PED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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