App-based Exercise Intervention for Persons With Acute Ankle Sprain

NCT ID: NCT03550274

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-03
• Study Completion Date: 2019-08-03

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.

Conditions

Ankle Sprains

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

App-based exercise rehabilitation

Persons with Acute lateral ankle sprain (\<48 hours) evaluated by a relevant health specialist in the hospital Emergency Department.

Group Type: EXPERIMENTAL

App-based exercise rehabilitation

Intervention Type: DEVICE

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.

Interventions

App-based exercise rehabilitation

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 Type: DEVICE

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen Center for Health Technology (CACHET)

UNKNOWN

Sponsor Role: collaborator

Technical University of Denmark (DTU)

UNKNOWN

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jonas Bak

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonas Bak, MSc

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

Hvidovre University Hospital

Copenhagen, Hvidove, Denmark

Countries

Denmark

References

Bak J, Thorborg K, Clausen MB, Johannsen FE, Kirk JW, Bandholm T. Using the app "Injurymap" to provide exercise rehabilitation for people with acute lateral ankle sprains seen at the Hospital Emergency Department-A mixed-method pilot study. PLOS Digit Health. 2023 May 15;2(5):e0000221. doi: 10.1371/journal.pdig.0000221. eCollection 2023 May.

Reference Type: DERIVED

PMID: 37186574 (View on PubMed)

Other Identifiers

17041467

Identifier Type: -

Identifier Source: org_study_id