A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries
ConditionAnkle Sprains
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-30
SponsorNaveen Poonai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Smartphone App
Other interventionApp that provides recovery guidance based on pain and functional outcomes
Standard of Care
Other interventionPaper based discharge instruction that provide information on pain management
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Smartphone AppExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
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.
Time frame
Day 7 post-ED dischargeSecondary outcomes
1
Pharmacologic analgesia
Mean (SD) number of doses of pain medication per day
Time frame
Days 1-7 post-ED discharge2
Non-pharmacologic analgesia
Mean (SD) number of non-pharmacologic analgesic measures used (ice, elevation) per day
Time frame
Days 1-7 post-ED discharge3
Range of motion (ROM) exercises
Mean (SD) number of times participant reported performing ROM exercises per day
Time frame
Days 1-7 post-ED discharge4
Verbal Numeric Rating Scale (vNRS) pain score
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.
Time frame
Day 7 post-ED dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Naveen Poonai
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor institution
Source ClinicalTrials.gov