Impact of Physiotherapy Intervention for Children With Ankle Sprains
This study is currently recruiting participants.
Verified June 2011 by McGill University Health Center
Sponsor:
McGill University Health Center
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01405274
First received: July 28, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
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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: | June 2012 (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
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
No publications provided
| Responsible Party: | Isabelle Gagnon, MUHC-Montreal Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01405274 History of Changes |
| Other Study ID Numbers: | 09-287-PED |
| Study First Received: | July 28, 2011 |
| Last Updated: | July 28, 2011 |
| Health Authority: | Canada: Health Canada |
ClinicalTrials.gov processed this record on May 23, 2013