Clinical trial NCT03550274: App-based Exercise Intervention for Persons With Acute Ankle Sprain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprains
Keywords: Acute lateral ankle sprain
Acute ankle injury
Ankle sprain
Exercise therapy
App-based rehabilitation
Mixed-method
Pilot Study
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Copenhagen Center for Health Technology (CACHET)
name: Technical University of Denmark (DTU)
First posted: 2018-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mixed method pilot cohort study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Acute lateral ankle sprain (\< 48 hours) evaluated by a relevant health specialist in the hospital Emergency department (HvH)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Return to work
timeFrame: Four months from ankle injury
measure: Return to sport
timeFrame: Four months from ankle injury
measure: Re-injuries in the same ankle
timeFrame: Four months from ankle injury
measure: Subjective feeling of ankle stability
timeFrame: Every week from ankle injury until four months after
measure: Subjective feeling of recovery
timeFrame: Four months from ankle injury
measure: Recruitment rate: Number of potentially eligible participants at the Emergency Department
timeFrame: From start of recruitment to the minimum of 60 participants has been achieved, but maximum 3 months
measure: Recruitment rate: Number of persons contacted by the health specialist for information about the study
timeFrame: From start of recruitment to the minimum of 60 participants has been achieved, but maximum 3 months
measure: Recruitment rate: Number of persons willing to participate.
timeFrame: From start of recruitment to the minimum of 60 participants has been achieved, but maximum 3 months
measure: Recruitment rate: Number of persons commencing the exercise program.
timeFrame: From start of recruitment to two weeks after the minimum of 60 participants has been achieved, but maximum 3 months and two weeks.
measure: Retention rate: Number of persons completing follow-up assessment.
timeFrame: Four months from ankle injury
measure: Retention rate: Number of sms responded.
timeFrame: Four months from ankle injury
measure: Adherence to exercise program: Number of exercise sessions completed.
timeFrame: Four months from ankle injury
measure: Adherence to exercise program: Number of weeks with minimum one exercise session.
timeFrame: Four months from ankle injury
Secondary outcomes:
Other outcomes:
measure: semi-structured interviews
timeFrame: two weeks after ended intervention but maximum 4 months and two weeks after the initial ankle injury.
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidove
Study officials:
affiliation: Hvidovre University Hospital
name: Jonas Bak, MSc
role: PRINCIPAL_INVESTIGATOR
References: