Recruiting

Smartphone App

Sponsor:

Naveen Poonai

Code:

NCT05785533

Conditions

Ankle Sprains

Eligibility Criteria

Sex: All

Age: 12 - 30

Healthy Volunteers: Not accepted

Interventions

Smartphone App

Standard of Care

Study Details

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.

Conditions

Ankle Sprains

Study ID

NCT05785533

Start date

Aug 24, 2024

Status verified date

Sep, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 30

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Smartphone App

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.

active comparator: Standard of Care

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.

Interventions

Smartphone App

App that provides recovery guidance based on pain and functional outcomes

Standard of Care

Paper based discharge instruction that provide information on pain management

Primary outcome measure

  • Activities Scale for Kids - performance version (ASKp) score [ Time Frame: Day 7 post-ED discharge ]

Central Contacts and Locations

Central contacts

Kamary Coriolano, PhD

5196858500Kamary.CoriolanoDaSilva@lhsc.on.ca

Naveen Poonai, MD

5196858500naveen.poonai@lhsc.on.ca

Locations

London Health Sciences Center

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Naveen Poonai, MD

5196858500naveen.poonai@lhsc.on.ca

More Information

Sponsor

Naveen Poonai

Last update posted

Sep 23, 2024

Last verified

Sep, 2024

Keywords

  • Ankle inversion injury
  • Mobile app
  • Recovery guidance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Naveen Poonai on 2024-09-23.