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Smartphone app for Ankle Sprain (SPRAIN Trial)

N/A
Waitlist Available
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
(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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 3, 5, 7, 10, and 12 +/- 1 day post-discharge
Awards & highlights

SPRAIN Trial Summary

This trial is testing whether a smartphone app can help improve outcomes for children with ankle sprains.

Eligible Conditions
  • Ankle Sprain

SPRAIN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

SPRAIN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 3, 5, 7, 10, and 12 +/- 1 day post-discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 3, 5, 7, 10, and 12 +/- 1 day post-discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Activities Scale for Kids performance version (ASKp)
Pain using the Faces Pain Scale - Revised (FPS-R)
Time to return to baseline ASKp score
+2 more

SPRAIN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Smartphone appExperimental Treatment1 Intervention
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.
Group II: Paper handoutActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
654 Previous Clinical Trials
413,125 Total Patients Enrolled
Janet Knechtel, BAStudy ChairLawson Health Research Institute
1 Previous Clinical Trials
250 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~12 spots leftby Mar 2025