Impact of Physiotherapy Intervention for Children With Ankle Sprains

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Isabelle Gagnon, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01405274
First received: July 28, 2011
Last updated: December 11, 2015
Last verified: December 2015
  Purpose
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 Intervention
Physical Therapy
Other: Physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • recurrence of ankle sprain [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physiotherapy intervention Other: Physiotherapy
Physiotherapy treatment bi-weekly, delivered at the child's home
No Intervention: standard care

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405274

Contacts
Contact: Isabelle Gagnon, PhD 514-412-4400 ext 22001 isabelle.gagnon8@mcgill.ca

Locations
Canada, Quebec
MUHC-Montreal Children's Hospital Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Isabelle Gagnon, PhD    514-412-4400 ext 22001    isabelle.gagnon8@mcgill.ca   
Sponsors and Collaborators
McGill University Health Center
  More Information

Responsible Party: Isabelle Gagnon, Clinical Scientist, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01405274     History of Changes
Other Study ID Numbers: 09-287-PED 
Study First Received: July 28, 2011
Last Updated: December 11, 2015
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on May 25, 2016