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

NCT05785533 | Recruiting

• 1 other identifier: 13428
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

Ankle inversion injury; Mobile app; Recovery guidance

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 7 post-ED discharge

Secondary Outcomes (5)

• Pharmacologic analgesia

  Days 1-7 post-ED discharge

• Non-pharmacologic analgesia

  Days 1-7 post-ED discharge

• Range of motion (ROM) exercises

  Days 1-7 post-ED discharge

• Verbal Numeric Rating Scale (vNRS) pain score

  Day 7 post-ED discharge

• Time to return to pre-injury ASKp score

  Days 1-14 post-ED discharge

Study Arms (2)

Smartphone App

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

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

Interventions

Smartphone App OTHER

App that provides recovery guidance based on pain and functional outcomes

Smartphone App

Standard of Care OTHER

Paper based discharge instruction that provide information on pain management

Standard of Care

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Naveen Poonai: lead

Study Sites (1)

London Health Sciences Center

London, Ontario, N6A 5W9, Canada

RECRUITING

MeSH Terms

Conditions

Ankle Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Janet Knechtel, BA

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  STUDY CHAIR

Central Study Contacts

Kamary Coriolano, PhD

CONTACT

5196858500; Kamary.CoriolanoDaSilva@lhsc.on.ca

Naveen Poonai, MD

CONTACT

5196858500; naveen.poonai@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 27, 2023
• Study Start: August 24, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

CA (1)