Physical TherapyNCT01405274
Impact of Physiotherapy Intervention for Children With Ankle Sprains
A study testing Physiotherapy in people with Physical Therapy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Physical Therapy
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 7 to 18
- confirmed diagnosis of ankle sprain
- Ability to Speak French or English
Who cannot join
- immobilization at the time of ED discharge
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Physical Therapy
- Being tested
- Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Physiotherapy treatment bi-weekly, delivered at the child's home
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy intervention | Experimental | Not described Receives: Other: Physiotherapy |
| standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of ankle sprain
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2016
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Gagnon, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405274
- Sponsor's protocol ID
- 09-287-PED
- Status last verified
- Apr 2019
- First submitted
- 28 Jul 2011
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01405274
- Acronym / sponsor ID
- 09-287-PED
- Conditions
- Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy intervention | Experimental | Other: Physiotherapy |
| standard care | No intervention | – |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 7 to 18
- confirmed diagnosis of ankle sprain
- Ability to Speak French or English
Key exclusion criteria (1 listed)
- immobilization at the time of ED discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyPhysiotherapy treatment bi-weekly, delivered at the child's home | Other | Physiotherapy intervention |
Primary outcome
recurrence of ankle sprain
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Physical Therapy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of ankle sprain (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.