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Идёт набор NCT05785533

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

Без фазы С лечением Ankle Sprains

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Smartphone App, Standard of Care.
Кому может быть актуально
Состояния в реестре: Ankle Sprains. Базовые параметры: 12 лет — 30 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries: a Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Smartphone App
    App that provides recovery guidance based on pain and functional outcomes
  • Другое Standard of Care
    Paper based discharge instruction that provide information on pain management

Первичные конечные точки

  • Activities Scale for Kids - performance version (ASKp) score [Срок оценки: Day 7 post-ED discharge]
Вторичные конечные точки (5)
  • Pharmacologic analgesia [Срок оценки: Days 1-7 post-ED discharge]
  • Non-pharmacologic analgesia [Срок оценки: Days 1-7 post-ED discharge]
  • Range of motion (ROM) exercises [Срок оценки: Days 1-7 post-ED discharge]
  • Verbal Numeric Rating Scale (vNRS) pain score [Срок оценки: Day 7 post-ED discharge]
  • Time to return to pre-injury ASKp score [Срок оценки: Days 1-14 post-ED discharge]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • London Health Sciences Center — London

Идентификаторы

NCT: NCT05785533 · 13428

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗