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

Primary Purpose

Ankle Sprains

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smartphone App
Standard of Care
Sponsored by
Naveen Poonai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains focused on measuring Ankle inversion injury, Mobile app, Recovery guidance

Eligibility Criteria

12 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Smartphone App

    Standard of Care

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Pharmacologic analgesia
    Mean (SD) number of doses of pain medication per day
    Non-pharmacologic analgesia
    Mean (SD) number of non-pharmacologic analgesic measures used (ice, elevation) per day
    Range of motion (ROM) exercises
    Mean (SD) number of times participant reported performing ROM exercises per day
    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 to return to pre-injury ASKp score
    Number of days until return to pre-injury ASKp score

    Full Information

    First Posted
    March 15, 2023
    Last Updated
    August 15, 2023
    Sponsor
    Naveen Poonai
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05785533
    Brief Title
    A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries
    Acronym
    SPRAIN
    Official Title
    A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Naveen Poonai

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Acute ankle sprains are one of the most common complaints presenting to primary care offices and EDs. In Canada and the United States, there are more than 2 million ED visits annually due to ankle trauma in children, with 85% of these ankle injuries having no visible bony fracture on radiographs. Furthermore 85% of these ankle sprains are due to forced inversion. Adolescents and young adults have the highest incidence of ankle sprain, with a peak incidence of 7.2 per 1,000 person-years for those 15 to 19 years of age. Although ankle sprains are often perceived as minor injuries, they can have a highly variable prognosis, with up to 64% of patients failing to achieve full recovery and the process may take up to 3 months. Current guidelines are limited in determining prognostic factors associated with functional recovery. The resulting 'one-size fits all' approach to management are controlling acute inflammatory symptoms, using ice and anti-inflammatory medications, alongside early mobilization fails to consider the grade of injury, baseline level of functioning, or individual pain tolerance of the child. Educational guidance individualized to pain beyond the ED may improve functional outcomes. As of November 2017, 76% of all Canadians own a smartphone, as per Statistics Canada. In a recent study of more than 1600 smartphone phone users in the US, over half (58%) had downloaded a health-related smartphone app. In adult medicine, many health-related smartphone apps have been shown to be associated with greater caregiver knowledge and improved outcomes in allergic rhinitis, post-operative monitoring, and musculoskeletal conditions. In children and adolescents, several studies have explored smartphone apps for asthma and diabetes. To date however, no smartphone apps have been developed for acute musculoskeletal injury management that are directed to children. This study will examine the utility of a smartphone app to provide discharge instructions and guide treatment using pharmacologic and non-pharmacologic approaches to assist with pain management and return to function in acute ankle inversion injuries, a leading cause of health care visits among children and adolescents.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankle Sprains
    Keywords
    Ankle inversion injury, Mobile app, Recovery guidance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Smartphone App
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Smartphone App
    Intervention Description
    App that provides recovery guidance based on pain and functional outcomes
    Intervention Type
    Other
    Intervention Name(s)
    Standard of Care
    Intervention Description
    Paper based discharge instruction that provide information on pain management
    Primary Outcome Measure Information:
    Title
    Activities Scale for Kids - performance version (ASKp) score
    Description
    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 discharge
    Secondary Outcome Measure Information:
    Title
    Pharmacologic analgesia
    Description
    Mean (SD) number of doses of pain medication per day
    Time Frame
    Days 1-7 post-ED discharge
    Title
    Non-pharmacologic analgesia
    Description
    Mean (SD) number of non-pharmacologic analgesic measures used (ice, elevation) per day
    Time Frame
    Days 1-7 post-ED discharge
    Title
    Range of motion (ROM) exercises
    Description
    Mean (SD) number of times participant reported performing ROM exercises per day
    Time Frame
    Days 1-7 post-ED discharge
    Title
    Verbal Numeric Rating Scale (vNRS) pain score
    Description
    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 discharge
    Title
    Time to return to pre-injury ASKp score
    Description
    Number of days until return to pre-injury ASKp score
    Time Frame
    Days 1-14 post-ED discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kamary Coriolano, PhD
    Phone
    5196858500
    Email
    Kamary.CoriolanoDaSilva@lhsc.on.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Naveen Poonai, MD
    Phone
    5196858500
    Email
    naveen.poonai@lhsc.on.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janet Knechtel, BA
    Organizational Affiliation
    Lawson Health Research Institute
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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