Back to resultsImpact of Physiotherapy Intervention for Children With Ankle Sprains
Primary Purpose
Physical Therapy
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Physical Therapy
Eligibility Criteria
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
Sites / Locations
- MUHC-Montreal Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physiotherapy intervention
standard care
Arm Description
Outcomes
Primary Outcome Measures
recurrence of ankle sprain
Secondary Outcome Measures
Full Information
NCT ID
NCT01405274
First Posted
July 28, 2011
Last Updated
April 2, 2019
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT01405274
Brief Title
Impact of Physiotherapy Intervention for Children With Ankle Sprains
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy intervention
Arm Type
Experimental
Arm Title
standard care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Physiotherapy treatment bi-weekly, delivered at the child's home
Primary Outcome Measure Information:
Title
recurrence of ankle sprain
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
MUHC-Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Physiotherapy Intervention for Children With Ankle Sprains
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