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A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries

A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries: a Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05785533
Acronym
SPRAIN
Enrollment
250
Registered
2023-03-27
Start date
2024-08-24
Completion date
2026-12-31
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprains

Keywords

Ankle inversion injury, Mobile app, Recovery guidance

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.

Interventions

OTHERSmartphone App

App that provides recovery guidance based on pain and functional outcomes

OTHERStandard of Care

Paper based discharge instruction that provide information on pain management

Sponsors

Naveen Poonai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 30 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Activities Scale for Kids - performance version (ASKp) scoreDay 7 post-ED dischargeThe 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.

Secondary

MeasureTime frameDescription
Pharmacologic analgesiaDays 1-7 post-ED dischargeMean (SD) number of doses of pain medication per day
Non-pharmacologic analgesiaDays 1-7 post-ED dischargeMean (SD) number of non-pharmacologic analgesic measures used (ice, elevation) per day
Range of motion (ROM) exercisesDays 1-7 post-ED dischargeMean (SD) number of times participant reported performing ROM exercises per day
Verbal Numeric Rating Scale (vNRS) pain scoreDay 7 post-ED dischargeThe 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 to return to pre-injury ASKp scoreDays 1-14 post-ED dischargeNumber of days until return to pre-injury ASKp score

Countries

Canada

Contacts

Primary ContactKamary Coriolano, PhD
Kamary.CoriolanoDaSilva@lhsc.on.ca5196858500
Backup ContactNaveen Poonai, MD
naveen.poonai@lhsc.on.ca5196858500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026