A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Activities Scale for Kids - performance version (ASKp) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Activities Scale for Kids - performance version (ASKp) score
时间窗: Day 7 post-ED discharge
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.
次要结局
- Verbal Numeric Rating Scale (vNRS) pain score(Day 7 post-ED discharge)
- Pharmacologic analgesia(Days 1-7 post-ED discharge)
- Non-pharmacologic analgesia(Days 1-7 post-ED discharge)
- Range of motion (ROM) exercises(Days 1-7 post-ED discharge)
- Time to return to pre-injury ASKp score(Days 1-14 post-ED discharge)
研究者
Naveen Poonai
Associate Professor
Lawson Health Research Institute