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NCT Number: NCT05785533

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

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.

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Key information

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Center

London, Ontario, N6A 5W9, Canada

Location status: Recruiting

Location contact

Naveen Poonai, MD

CONTACT

[email protected]

5196858500 ext. 52011

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Smartphone app

Other

App that provides recovery guidance based on pain and functional outcomes

Standard of care

Other

Paper based discharge instruction that provide information on pain management

Primary outcomes

  1. Activities Scale for Kids - performance version (ASKp) score

    Time frame: Day 7 post-ED discharge

    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.

Secondary outcomes

  1. Pharmacologic analgesia

    Time frame: Days 1-7 post-ED discharge

    Mean (SD) number of doses of pain medication per day

  2. Non-pharmacologic analgesia

    Time frame: Days 1-7 post-ED discharge

    Mean (SD) number of non-pharmacologic analgesic measures used (ice, elevation) per day

  3. Range of motion (ROM) exercises

    Time frame: Days 1-7 post-ED discharge

    Mean (SD) number of times participant reported performing ROM exercises per day

  4. Verbal Numeric Rating Scale (vNRS) pain score

    Time frame: Day 7 post-ED discharge

    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.

  5. Time to return to pre-injury ASKp score

    Time frame: Days 1-14 post-ED discharge

    Number of days until return to pre-injury ASKp score

Study contacts

Contact information is provided by the study sponsor or research team.

Kamary Coriolano, PhD

CONTACT

[email protected]

5196858500

Naveen Poonai, MD

CONTACT

[email protected]

5196858500

Sponsors and collaborators

Lead sponsor

Naveen Poonai

Other

Registry information

Official study title

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

Acronym: SPRAIN

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2023
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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