An interventional study of Smartphone App and Standard of Care in Ankle Sprains, sponsored by Naveen Poonai. Recruiting at 1 site in Canada. Open to participants aged 12 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by Naveen Poonai · Not applicable, Interventional, and Treatment
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.
Acute ankle sprains are one of the most common complaints presenting to primary care offices and EDs. In Canada and the United States, there are more than 2 million ED visits annually due to ankle trauma in children, with 85% of these ankle injuries having no visible bony fracture on radiographs. Furthermore 85% of these ankle sprains are due to forced inversion. Adolescents and young adults have the highest incidence of ankle sprain, with a peak incidence of 7.2 per 1,000 person-years for those 15 to 19 years of age. Although ankle sprains are often perceived as minor injuries, they can have a highly variable prognosis, with up to 64% of patients failing to achieve full recovery and the process may take up to 3 months. Current guidelines are limited in determining prognostic factors associated with functional recovery. The resulting 'one-size fits all' approach to management are controlling acute inflammatory symptoms, using ice and anti-inflammatory medications, alongside early mobilization fails to consider the grade of injury, baseline level of functioning, or individual pain tolerance of the child. Educational guidance individualized to pain beyond the ED may improve functional outcomes.
As of November 2017, 76% of all Canadians own a smartphone, as per Statistics Canada. In a recent study of more than 1600 smartphone phone users in the US, over half (58%) had downloaded a health-related smartphone app. In adult medicine, many health-related smartphone apps have been shown to be associated with greater caregiver knowledge and improved outcomes in allergic rhinitis, post-operative monitoring, and musculoskeletal conditions. In children and adolescents, several studies have explored smartphone apps for asthma and diabetes. To date however, no smartphone apps have been developed for acute musculoskeletal injury management that are directed to children.
This study will examine the utility of a smartphone app to provide discharge instructions and guide treatment using pharmacologic and non-pharmacologic approaches to assist with pain management and return to function in acute ankle inversion injuries, a leading cause of health care visits among children and adolescents.
362 studies on the registry are indexed under Ankle Injuries; 72 are open to participants now.
This study's planned enrollment of 250 is above the median of 60 across 281 interventional studies indexed under Ankle Injuries.
Browse Ankle Injuries studies →Naveen Poonai is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The mobile app will allow recording of study outcomes (pain using the vNRS and functional outcomes using the ASKp) and house an interactive educational component to provide daily reminders on pharmacological (ibuprofen and acetaminophen) and non-pharmacological (ice, elevation, and range of motion exercises) for pain management and when to return to activity. The app will collect pain scores using the verbal Numeric Rating Scale (vNRS) and functional outcomes using the Activities Scale for Kids (ASKp) scores on days 3, 5, 7, 10, 12, and 14. The ASKp will be completed by the child with assistance from the caregiver.
Other: Smartphone App
The standard of care group will be asked to read the paper-based discharge instructions in the ED, outlining pharmacological and non-pharmacological pain management and return to activity identical to the information contained in the mobile app. They will download onto their smartphone device a Data Collection App that will only allow them to record the following study outcome measures: daily use of ice, analgesia, range of motion exercises, elevation, and pain using the vNRS and ASKp scores on days 3, 5, 7, 10, 12, and 14. The ASKp will be completed by the child with assistance from the caregiver.
Other: Standard of Care
App that provides recovery guidance based on pain and functional outcomes
Paper based discharge instruction that provide information on pain management
Activities Scale for Kids - performance version (ASKp) score
The ASKp is a self-reported scale of children's physical functioning at home, school, and in the playground. The measure includes 30 questions with total scores ranging from 0 to 100.
Time frame: Day 7 post-ED discharge
Pharmacologic analgesia
Mean (SD) number of doses of pain medication per day
Time frame: Days 1-7 post-ED discharge
Non-pharmacologic analgesia
Mean (SD) number of non-pharmacologic analgesic measures used (ice, elevation) per day
Time frame: Days 1-7 post-ED discharge
Range of motion (ROM) exercises
Mean (SD) number of times participant reported performing ROM exercises per day
Time frame: Days 1-7 post-ED discharge
Verbal Numeric Rating Scale (vNRS) pain score
The vNRS is a self-reported pain scale ranging from 0 (no pain) to 10 (maximal pain). The score will reflect the global rating of pain for the day.
Time frame: Day 7 post-ED discharge
Time to return to pre-injury ASKp score
Number of days until return to pre-injury ASKp score
Time frame: Days 1-14 post-ED discharge
Started Aug 2024 (actual). Primary completion is estimated for Sep 2026, 24 months after the start.
Of 133 non-industry interventional studies with no phase under Ankle Injuries, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 31. This study's planned 24 months is above that.
Counting every sponsor, half of 137 studies reached it within 9 months; a quarter within 4 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Naveen Poonai