Actively Recruiting
A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries: a Randomized Controlled Trial
Led by Naveen Poonai · Updated on 2024-09-23
250
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ankle sprains are a common injury, especially among children and adolescents, leading to prolonged pain and delayed return to normal activities. This trial investigates whether using a smartphone app for children and young adults with acute ankle inversion injuries improves functional outcomes such as pain, mobility, and return to activity compared to standard paper handouts. The study focuses on guidance tailored to pain management and recovery, aiming to overcome the limitations of current one-size-fits-all care approaches. Participants will be randomly assigned to one of two groups: one group will use a smartphone app that provides education, daily reminders on pain management including medication and exercises, and collects pain and functional scores at several timepoints up to 14 days. The other group will receive standard care through paper-based discharge instructions and will use a data collection app only for recording outcomes. The app-based group receives interactive support, while the standard care group receives the same information in printed form. During the study, participants will record pain levels and functional abilities using standardized scales on days 3, 5, 7, 10, 12, and 14 after discharge. Researchers will monitor pain management methods, range of motion exercises, and time to return to pre-injury function. The primary outcome is the Activities Scale for Kids-performance version score on day 7 post-discharge. The study includes children and young adults aged 12 to 30 years and involves assessments focused on recovery progress and safety over the two-week period.
CONDITIONS
Brief Title
A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12-30 years
- Presenting with a unilateral acute ankle injury within 48 hours diagnosed by an emergency physician
- Able to use a WiFi-enabled smartphone with iOS or Android and enough memory to install the app
You will not qualify if you...
- Unable to read or understand English at least at a grade 8 literacy level without an interpreter
- Not able to walk independently before the injury without assistive devices
- Developmental disability preventing full understanding of study procedures
- Having multiple injuries affecting more than one limb or system
- Having a confirmed lower extremity fracture or dislocation except suspected Salter-Harris type I injury
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 14 days post-ED discharge
Participants use either a smartphone app providing daily recovery guidance and pain management reminders or receive paper-based discharge instructions, while recording pain and functional outcomes over two weeks.
Outcome data recorded on days 3, 5, 7, 10, 12, and 14
Trial Site Locations
Total: 1 location
1
London Health Sciences Center
London, Ontario, Canada, N6A 5W9
Actively Recruiting
Research Team
K
Kamary Coriolano, PhD
N
Naveen Poonai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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