A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries (NCT05785533) | Clinical Trial Compass
RecruitingNot Applicable
A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries
Canada250 participantsStarted 2024-08-24
Plain-language summary
Ankle sprains are the most common musculoskeletal complaint of children presenting to the emergency department (ED). Healing can often be protracted, leading to prolonged pain, missed school and work, and delayed return to a normal activity level. Smartphone apps have been shown to be associated with greater caregiver knowledge and improved outcomes in a number of conditions but have not been explored in ankle sprains. We would like to know if using a smartphone app for children with ankle inversion injuries leads to improved functional outcomes such as pain, mobility, and return to activity. We will be comparing a smartphone app that provides education and daily management reminders to a paper handout to see if the former leads to improved functional recovery.
Who can participate
Age range
12 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 12-30 years
* Presenting to the Paediatric Emergency Department of the Children's Hospital or Adult Emergency Department, London Health Sciences Centre, London, or ntario, St. Joseph Urgent Care Centre, London, Ontario, with a unilateral acute (\<= 48 hours) ankle injury based on clinical diagnosis by ED physician
* Able to use a WiFi enabled smartphone with either an iOS or Android operating system with enough memory capability to host the App.
Exclusion Criteria:
* Unable to read or understand English above at least a grade 8 literacy level in the absence of a native language interpreter
* Not independently ambulatory prior to injury (without the use of an assistive device)
* Developmental disability precluding the full comprehension of study-related procedures
* Multi-system or multi-limb injuries
* Concomitant radiographically proven lower extremity fracture or dislocation (with the exception of a suspected Salter-Harris type I injury)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Activities Scale for Kids - performance version (ASKp) score