Smartphone App to Improve Functional Outcomes in Ankle Sprains (NCT03564015) | Clinical Trial Compass
TerminatedNot Applicable
Smartphone App to Improve Functional Outcomes in Ankle Sprains
Stopped: The intervention (guidance recovery app) was malfunctioning and not storing data for efficacy outcomes.
Canada60 participantsStarted 2020-02-01
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. The investigators 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. The investigators 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 – 21 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:
(i) Age 12-21 years (ii) Presenting to the Emergency Department of the Children's Hospital, London Health Sciences Centre, London, Ontario, with a unilateral acute (\<48 hours) ankle inversion injury.
(iii) Use a WiFi enabled smartphone with either an iOS or Android operating system with enough memory capability to host the App.
The diagnosis of an ankle inversion injury will be made on a clinical basis by the treating emergency physician after a fracture has been ruled out radiographically. We will include all grades of ankle injuries, including suspected Salter-Harris I of the distal tibia or fibula.
Exclusion Criteria:
* Children unable to read or understand English above at least a grade 8 literacy level
* Children who are not independently ambulatory (without the use of an assistive device)
* Children with a developmental disability precluding the full comprehension of study-related procedures,
* Children with multi-system or multi-limb injuries
* Children with a concomitant 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)
Timeframe: Day 14 +/- 1 day post-discharge
Trial details
NCT IDNCT03564015
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's