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Impact of Physiotherapy Intervention for Children With Ankle Sprains

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01405274
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Isabelle Gagnon, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Physical Therapy Other: Physiotherapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2011
Actual Primary Completion Date : March 2016
Actual Study Completion Date : June 1, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Physiotherapy intervention Other: Physiotherapy
Physiotherapy treatment bi-weekly, delivered at the child's home
No Intervention: standard care


Outcome Measures
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Primary Outcome Measures :
  1. recurrence of ankle sprain [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405274


Locations
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Canada, Quebec
MUHC-Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
More Information
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Responsible Party: Isabelle Gagnon, Clinical Scientist, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT01405274    
Other Study ID Numbers: 09-287-PED
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ankle Injuries
Wounds and Injuries
Leg Injuries