A Pilot Study Investigating the Use and Preliminary Effect of the App "Injury-map" in Providing Exercise Rehabilitation for Persons With Acute Lateral Ankle Sprains Seen at the Emergency Department - a Mixed-method Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Return to work
研究概览
简要总结
Acute lateral ankle sprains (ALAS) account for 4-5% of all Emergency Department visits in Denmark. Up to 2/3 of individuals with a history of lateral ankle sprain have prolonged symptoms for several years after their initial injury. Exercise therapy has proven to be a cost-effective rehabilitation in treating ALAS and in preventing re-injury. Injury-map© is an exercise app designed for treating different musculoskeletal problems including ALAS. The app has currently not been tested in a clinical trial with patients suffering from ALAS. This mixed method pilot cohort study aims to investigate the use and preliminary effect of an exercise program on a mobile device in patients with ALAS. The exercise program is designed to be completed within approximately 3 months. However, participants will be followed as long as they complete minimum 1 exercise session per week. If a participant is inactive for two weeks they will be considered completed and contacted for follow-up assessment.
详细描述
Acute lateral ankle sprains (ALAS) account for 4-5% of all Emergency Department visits in Denmark and is the most common injury in sporting activities. It is often regarded as an innocuous injury but in truth up to 2/3 of individuals with a history of lateral ankle sprain have prolonged symptoms such as pain, decreased function and subjective instability for several years after their initial injury. Exercise therapy has proven to be a cost-effective rehabilitation in treating ALAS and in preventing re-injury. The financial modality of ALAS is high but exercise therapy has proven to be a cost-effective rehabilitation in treating ALAS and in preventing re-injury.
Modern technology has the potential to be a powerful tool in providing easily accessible exercise programs. Injury-map© is an exercise app designed for treating different musculoskeletal problems including ALAS. The exercise program has been developed by health professionals and has the potential to provide an easy-accessible management of ALAS rehabilitation. However, the app has currently not been tested in a clinical trial with patients suffering from ALAS. Before undertaking a large scale trial, the investigators wish to pilot test the app to assess the use and preliminary effect of the app-based exercise program.
This study aims to investigate the use and preliminary effect of an exercise program on a mobile device in patients with ALAS when seen in the Emergency Room at a public hospital. It is designed as a mixed method pilot cohort study. The SPIRIT checklist for trial protocols and the PREPARE trial guide have been used for the overall framework of this protocol.
Approximately 60 participants will be recruited from the Emergency Department (ED) at Hvidovre Hospital (HvH). Health specialists associated with the ED and responsible for ankle examinations will recruit participants . If a health specialist deems a person eligible, they will deliver a bag containing a rubber band and project description. If a participant is willing to participate in the project, they can contact the study administrator by the contact information in the written material. When contact is established participants will receive a voucher for the app, informed consent and a baseline questionnaire.
The exercise program will be available on any mobile device and/or tablet using Android or iOS. It is expected that patients primarily will exercise mainly at home. Participants will be followed as long as they actively use the exercise app or for a maximum of four months. When a participant has been inactive for more than two weeks, the participants are considered finalized and will be contacted for follow-up assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute lateral ankle sprain (< 48 hours) evaluated by a relevant health specialist in the hospital Emergency department (HvH)
排除标准
- •Fracture of the leg or foot (Ottawa rules and/or x-ray)
- •Previous surgery in the ankle or as a consequence of the current ankle distortion.
- •Other serious injury to the body in relation to the ankle injury incidence.
- •Serious illness (terminal patients, RA, Fibromyalgia etc).
- •Not having a smartphone or tablet.
- •Unable to understand Danish.
结局指标
主要结局
Return to work
时间窗: Four months from ankle injury
Number of whole days absent from work due to the ankle injury
Return to sport
时间窗: Four months from ankle injury
Number of exercise sessions not able to fully attend due to the ankle injury
Re-injuries in the same ankle
时间窗: Four months from ankle injury
Total number of re-sprains categorized into two groups. 1) Ankle sprains with no time loss and 2) ankle sprains with time-loss defined as unable to continue current activity and/or unable to participate in work/sport activities the next days because of the ankle.
Subjective feeling of ankle stability
时间窗: Every week from ankle injury until four months after
0-10 points, where 0 is completely stable and 10 is very unstable. The participant writes a number within the indicated range that equates to their subjective feeling of stability.
Subjective feeling of recovery
时间窗: Four months from ankle injury
Do you feel able to do the same activities on the same level as before the injury. answer: YES or NO.
Recruitment rate: Number of potentially eligible participants at the Emergency Department
时间窗: From start of recruitment to the minimum of 60 participants has been achieved, but maximum 3 months
Database search off registered ankle injuries at the Emergency Department in the recruitment period
Recruitment rate: Number of persons contacted by the health specialist for information about the study
时间窗: From start of recruitment to the minimum of 60 participants has been achieved, but maximum 3 months
Number of delivered recruitment bags containing project information and rubber bands by the health personel at the Emergency Department.
Recruitment rate: Number of persons willing to participate.
时间窗: From start of recruitment to the minimum of 60 participants has been achieved, but maximum 3 months
Number of participants who contacts the project administration for participation in the exercise project.
Recruitment rate: Number of persons commencing the exercise program.
时间窗: From start of recruitment to two weeks after the minimum of 60 participants has been achieved, but maximum 3 months and two weeks.
Number of participants included in the project who commence the exercise program.
Retention rate: Number of persons completing follow-up assessment.
时间窗: Four months from ankle injury
The number of participants completing the four month follow-up questionnaire of the total number included participants.
Retention rate: Number of sms responded.
时间窗: Four months from ankle injury
The number of sms responded of the total number of sms send.
Adherence to exercise program: Number of exercise sessions completed.
时间窗: Four months from ankle injury
The number of sessions completed is extracted from the app database.
Adherence to exercise program: Number of weeks with minimum one exercise session.
时间窗: Four months from ankle injury
The number of sessions completed in each week is extracted from the app database.
次要结局
未报告次要终点
研究者
Jonas Bak
Research assistant
Hvidovre University Hospital