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Trial record 42 of 345 for:    sprains and strains

App-based Exercise Intervention for Persons With Acute Ankle Sprain

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ClinicalTrials.gov Identifier: NCT03550274
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : January 3, 2019
Sponsor:
Collaborators:
Copenhagen Center for Health Technology (CACHET)
Technical University of Denmark (DTU)
Information provided by (Responsible Party):
Jonas Bak, Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Ankle Sprains Device: App-based exercise rehabilitation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Mixed method pilot cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: App-based exercise rehabilitation
Persons with Acute lateral ankle sprain (<48 hours) evaluated by a relevant health specialist in the hospital Emergency Department.
Device: 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.





Primary Outcome Measures :
  1. Return to work [ Time Frame: Four months from ankle injury ]
    Number of whole days absent from work due to the ankle injury

  2. Return to sport [ Time Frame: Four months from ankle injury ]
    Number of exercise sessions not able to fully attend due to the ankle injury

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.


Other Outcome Measures:
  1. semi-structured interviews [ Time Frame: two weeks after ended intervention but maximum 4 months and two weeks after the initial ankle injury. ]
    To uncover user experiences with the app-based exercise program.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550274


Contacts
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Contact: Jonas Bak, MSc +4528140125 jonas.bak.01@regionh.dk
Contact: Thomas Q. Bandholm, Prof. +4538626344 thomas.quaade.bandholm@regionh.dk

Locations
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Denmark
Hvidovre University Hospital Recruiting
Copenhagen, Hvidove, Denmark, 2650
Contact: Mette B. Lindstrøm    38623308    mette.bendtz.lindstroem@regionh.dk   
Sponsors and Collaborators
Hvidovre University Hospital
Copenhagen Center for Health Technology (CACHET)
Technical University of Denmark (DTU)
Investigators
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Principal Investigator: Jonas Bak, MSc Hvidovre University Hospital

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Responsible Party: Jonas Bak, Research assistant, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03550274     History of Changes
Other Study ID Numbers: 17041467
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jonas Bak, Hvidovre University Hospital:
Acute lateral ankle sprain
Acute ankle injury
Ankle sprain
Exercise therapy
App-based rehabilitation
Mixed-method
Pilot Study

Additional relevant MeSH terms:
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Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries