Ankle SprainsNCT03550274
App-based Exercise Intervention for Persons With Acute Ankle Sprain
A study testing App-based exercise rehabilitation in people with Ankle Sprains, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 120 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- App-based exercise rehabilitation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jul 2018to 3 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute lateral ankle sprain (< 48 hours) evaluated by a relevant health specialist in the hospital Emergency department (HvH)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- App-based exercise rehabilitation
- Keywords
- Acute lateral ankle sprain, Acute ankle injury, Ankle sprain, Exercise therapy, App-based rehabilitation, Mixed-method, Pilot Study
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based exercise rehabilitationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| App-based exercise rehabilitation | Experimental | Persons with Acute lateral ankle sprain (<48 hours) evaluated by a relevant health specialist in the hospital Emergency Department. Receives: Device: App-based exercise rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work
Number of whole days absent from work due to the ankle injury
Measured: Four months from ankle injury
Return to sport
Number of exercise sessions not able to fully attend due to the ankle injury
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Four months from ankle injury
Retention rate: Number of sms responded.
The number of sms responded of the total number of sms send.
Measured: 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.
Measured: 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.
Measured: Four months from ankle injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start3 Jul 2018
- Primary completion3 Aug 2019
- Study completion3 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mixed method pilot cohort study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Center for Health Technology (CACHET), Technical University of Denmark
- Responsible party
- Principal investigator, Jonas Bak, Hvidovre University Hospital
- Investigators
- Jonas Bak, MSc, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550274
- Sponsor's protocol ID
- 17041467
- Status last verified
- Nov 2019
- First submitted
- 1 May 2018
- Last updated
- 13 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37186574
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03550274
- Acronym / sponsor ID
- 17041467
- Conditions
- Ankle Sprains
- Keywords
- Acute lateral ankle sprain, Acute ankle injury, Ankle sprain, Exercise therapy, App-based rehabilitation, Mixed-method, Pilot Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Copenhagen Center for Health Technology (CACHET), Technical University of Denmark
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 3 Aug 2019 (actual)
- Study completion
- 3 Aug 2019 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed method pilot cohort study
| Arm | Type | Receives |
|---|---|---|
| App-based exercise rehabilitation | Experimental | Device: App-based exercise rehabilitationPersons with Acute lateral ankle sprain (<48 hours) evaluated by a relevant health specialist in the hospital Emergency Department. |
Who may qualify
- Ages
- 5 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Acute lateral ankle sprain (< 48 hours) evaluated by a relevant health specialist in the hospital Emergency department (HvH)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based exercise rehabilitationApp-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. | Device | App-based exercise rehabilitation |
Primary outcome
Return to work
Time frame: Four months from ankle injury
Number of whole days absent from work due to the ankle injury
Return to sport
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Four months from ankle injury
The number of sessions completed in each week is extracted from the app database.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Derived from this study: PubMed 37186574Bak 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.
- Individual participant dataSharing planned: Undecided
Related trials for Ankle Sprains
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Recruiting
Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability
Ankle Sprains
RecruitingObservational study
Computed Tomography With Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability (CTMETS)
Ankle Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Bak, MSc principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based exercise rehabilitation in people with Ankle Sprains, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to work (time frame: Four months from ankle injury). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03550274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.