App-based Exercise Intervention for Persons With Acute Ankle Sprain
Condition: Ankle Sprains
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Participants will receive a weekly SMS string where information of return to activity and
      subjective feeling of instability will be collected. The SMS string will send ever for four
      months. At follow-up assessment participants will receive a questionnaire containing
      questions of their experience with the exercise app. A number of participants will be
      selected to semi-structured interview to elaborate their user experience with the app. This
      selection will be based on the participants completion of exercises in the app. AT the ED and
      in the app system recruitment rates and adherence to the exercise program will be extracted.

      Baseline characteristics will be summarized with suitable descriptive statistics.

      For the aim of investigating the use of the App, adherence will be presented as the number of
      exercise sessions completed each week as well as average estimations. The results will be
      compared to an evidence-based exercise dose. Recruitment rates, retention rates will be
      presented in suitable descriptive tables. Any harms will be addressed individually.

      Intervention outcomes will be summarized and tendencies in treatment effect will be compared
      with comparable literature, however no formal hypothesis testing will be performed, as the
      study uses a pilot design. Being an exploratory pilot study, the study is designed with a
      flat outcome structure with multiple evenly valued outcome measures.

      Interviews will be recorded and transcribed verbatim. The data will be analysed using a
      thematic approach. The data will be coded and recurring phrases or words will be grouped into
      basic themes. These themes will be clustered into global themes which will be verified by
      comparison to the coded data [23]. Differences between participants who complete the
      intervention and those who do not will be discussed.

      The enrollment process will start in April 2018 and conclude when 60 participants have been
      enrolled in the study.
    

Intervention name(s): App-based exercise rehabilitation
Intervention type(s): Device
Intervention description(s): App-based exercise rehabilitation available on any mobile device and/or tablet using Android or iOS operating systems. The app Injurymap© is hosting the exercise program. The app requires user-registrations and a monthly paid subscription fee to access the exercise program. The participants in this study will not be charged for using the app.
The exercise program consists of three phases with increasing difficulty. Each phase consists of several categories of exercise types. The categories are 1) mobility, 2) stability/balance, 3) strength and 4) stretching. Within each phase, there can be more than one exercise for each category. This makes it possible to adjust the difficulty of the exercises depending on user-feedback.
Intervention model: Single Group Assignment
Intervention model description: Mixed method pilot cohort study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute lateral ankle sprain; Acute ankle injury; Ankle sprain; Exercise therapy; App-based rehabilitation; Mixed-method; Pilot Study