Clinical trial NCT05785533: A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries
Official title: A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankle Sprains
Keywords: Ankle inversion injury
Mobile app
Recovery guidance
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 250
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Activities Scale for Kids - performance version (ASKp) score
timeFrame: Day 7 post-ED discharge
Secondary outcomes:
measure: Pharmacologic analgesia
timeFrame: Days 1-7 post-ED discharge
measure: Non-pharmacologic analgesia
timeFrame: Days 1-7 post-ED discharge
measure: Range of motion (ROM) exercises
timeFrame: Days 1-7 post-ED discharge
measure: Verbal Numeric Rating Scale (vNRS) pain score
timeFrame: Day 7 post-ED discharge
measure: Time to return to pre-injury ASKp score
timeFrame: Days 1-14 post-ED discharge
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Janet Knechtel, BA
role: STUDY_CHAIR
References: