NCT01405274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

4.7 years

First QC Date

July 28, 2011

Last Update Submit

April 2, 2019

Conditions

Physical Therapy

Outcome Measures

Primary Outcomes (1)

  • recurrence of ankle sprain

    12 months

Study Arms (2)

Physiotherapy intervention

EXPERIMENTAL
Other: Physiotherapy

standard care

NO INTERVENTION

Interventions

PhysiotherapyOTHER

Physiotherapy treatment bi-weekly, delivered at the child's home

Physiotherapy intervention

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 7 to 18
  • confirmed diagnosis of ankle sprain
  • Ability to Speak French or English

You may not qualify if:

  • immobilization at the time of ED discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUHC-Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Scientist

Study Record Dates

First Submitted

July 28, 2011

First Posted

July 29, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2016

Study Completion

June 1, 2018

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)