Smartphone App to Improve Functional Outcomes in Ankle Sprains

NCT03564015 | Terminated

• 1 other identifier: 111817
• Study Type: interventional
• Target: 60
• 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. The investigators 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. The investigators 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

Outcome Measures

Primary Outcomes (1)

• Activities Scale for Kids performance version (ASKp)

  30 item self-report questionnaire on functional performance with total score ranging from 0-100 with higher values representing greater function

  Day 14 +/- 1 day post-discharge

Secondary Outcomes (5)

• Activities Scale for Kids performance version (ASKp)

  Day 3, 5, 7, 10, and 12 +/- 1 day post-discharge

• Time to return to baseline ASKp score

  Days 1-14 post discharge

• Pain using the Faces Pain Scale - Revised (FPS-R)

  Days 1-14 post discharge

• Use of non-pharmacological measures (ice, compression, other)

  Days 1-14 post discharge

• Use of pharmacological analgesia (NSAIDs, acetaminophen)

  Days 1-14 post discharge

Study Arms (2)

Smartphone app

EXPERIMENTAL

The smartphone group will not be given paper-based discharge instructions in the ED. They will download onto their smartphone device an Intervention App that will allow recording of the above mentioned study outcomes and contains an interactive educational component encompassing the identical information outlined in the paper handout. The app will provide educational guidance towards recovery using a feedback algorithm that will recommend on a daily basis, the use of ice, elevation, range of motion exercises, and/or analgesics based on the participant's report of their pain using the FPS-R.

Other: Smartphone app

Paper handout

ACTIVE COMPARATOR

The paper handout 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. They will download onto their smartphone device a Recording App that will only allow them to record the following study outcome measures: daily use of ice, analgesia, range of motion exercises, elevation, pain using the Faces Pain Scale - Revised (FPS-R), and ASKp scores on days 3, 5, 7, 10, 12, and 14.

Other: Paper handout

Interventions

Smartphone app OTHER

Apple or Android app to provide education to guide functional recovery and allow recording of pain, management, and functional outcome using the Activities Scale for Kids performance version (ASKp) at home

Smartphone app

Paper handout OTHER

Paper handout to guide functional recovery. Also includes a version of the smartphone app described above that only allows recording of pain, functional outcome, and management at home.

Paper handout

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• (i) Age 12-21 years (ii) Presenting to the Emergency Department of the Children's Hospital, London Health Sciences Centre, London, Ontario, with a unilateral acute (\<48 hours) ankle inversion injury.
• (iii) Use a WiFi enabled smartphone with either an iOS or Android operating system with enough memory capability to host the App.
• The diagnosis of an ankle inversion injury will be made on a clinical basis by the treating emergency physician after a fracture has been ruled out radiographically. We will include all grades of ankle injuries, including suspected Salter-Harris I of the distal tibia or fibula.

You may not qualify if:

• Children unable to read or understand English above at least a grade 8 literacy level
• Children who are not independently ambulatory (without the use of an assistive device)
• Children with a developmental disability precluding the full comprehension of study-related procedures,
• Children with multi-system or multi-limb injuries
• Children with a concomitant lower extremity fracture or dislocation (with the exception of a suspected Salter-Harris type I injury).

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Janet Knechtel, BA

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

  STUDY CHAIR

Study Design

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

Model Details: Parallel group, randomized, open-label, controlled trial

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: June 20, 2018
• Study Start: February 1, 2020
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)