App-based Exercise Intervention for Persons With Acute Ankle Sprain

NCT03550274 | Completed

• 1 other identifier: 17041467
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprains

Keywords

Acute lateral ankle sprain; Acute ankle injury; Ankle sprain; Exercise therapy; App-based rehabilitation; Mixed-method; Pilot Study

Outcome Measures

Primary Outcomes (13)

• Return to work

  Number of whole days absent from work due to the ankle injury

  Four months from ankle injury

• Return to sport

  Number of exercise sessions not able to fully attend due to the ankle injury

  Four months from ankle injury

• Re-injuries in the same ankle

  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.

  Four months from ankle injury

• Subjective feeling of ankle stability

  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.

  Every week from ankle injury until four months after

• Subjective feeling of recovery

  Do you feel able to do the same activities on the same level as before the injury. answer: YES or NO.

  Four months from ankle injury

• Recruitment rate: Number of potentially eligible participants at the Emergency Department

  Database search off registered ankle injuries at the Emergency Department in the recruitment period

  From start of recruitment to the minimum of 60 participants has been achieved, but maximum 3 months

• Recruitment rate: Number of persons contacted by the health specialist for information about the study

  Number of delivered recruitment bags containing project information and rubber bands by the health personel at the Emergency Department.

  From start of recruitment to the minimum of 60 participants has been achieved, but maximum 3 months

• Recruitment rate: Number of persons willing to participate.

  Number of participants who contacts the project administration for participation in the exercise project.

  From start of recruitment to the minimum of 60 participants has been achieved, but maximum 3 months

• Recruitment rate: Number of persons commencing the exercise program.

  Number of participants included in the project who commence the exercise program.

  From start of recruitment to two weeks after the minimum of 60 participants has been achieved, but maximum 3 months and two weeks.

• Retention rate: Number of persons completing follow-up assessment.

  The number of participants completing the four month follow-up questionnaire of the total number included participants.

  Four months from ankle injury

• Retention rate: Number of sms responded.

  The number of sms responded of the total number of sms send.

  Four months from ankle injury

• Adherence to exercise program: Number of exercise sessions completed.

  The number of sessions completed is extracted from the app database.

  Four months from ankle injury

• Adherence to exercise program: Number of weeks with minimum one exercise session.

  The number of sessions completed in each week is extracted from the app database.

  Four months from ankle injury

Other Outcomes (1)

• semi-structured interviews

  two weeks after ended intervention but maximum 4 months and two weeks after the initial ankle injury.

Study Arms (1)

App-based exercise rehabilitation

EXPERIMENTAL

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

Device: App-based exercise rehabilitation

Interventions

App-based exercise rehabilitation 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.

App-based exercise rehabilitation

Eligibility Criteria

• Age: 5 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Copenhagen Center for Health Technology (CACHET): collaborator
• Technical University of Denmark (DTU): collaborator

Study Sites (1)

Hvidovre University Hospital

Copenhagen, Hvidove, 2650, Denmark

Location

Related Publications (1)

• 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.

  PMID: 37186574 DERIVED

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Jonas Bak, MSc

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: Mixed method pilot cohort study

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: June 8, 2018
• Study Start: July 3, 2018
• Primary Completion: August 3, 2019
• Study Completion: August 3, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

DK (1)