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Elite Athletes With Chronic Ankle Instability Using Spraino®: A Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706729
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Copenhagen University Hospital, Hvidovre
Aalborg University
Metropolitan University College
Spraino
Information provided by (Responsible Party):
Behnam Liaghat, University of Southern Denmark

Brief Summary:
Fear of re-injury and deficiencies in ankle joint function are common conditions amongst high performance (elite) athletes with chronic ankle instability (CAI), who participate in indoor sports. This fear of re-injury associates with the high recurrence rate of lateral ankle sprains, which is a primary characteristic feature of CAI. The Spraino® shoe patch is a new Danish invention, which is designed to reduce the risk of sustaining lateral ankle sprains in this population. This cohort study will investigate self-reported fear of re-injury and objectively measured ankle joint function in elite indoor sports athletes with CAI, both before and after a 10-week period during which they will use Spraino® during all training sessions and games.

Condition or disease Intervention/treatment Phase
Chronic Ankle Instability Device: Spraino Not Applicable

Detailed Description:

Acute lateral ankle sprains are frequently incurred by athletes, who participate in indoor sports such as volleyball, handball, and badminton; accounting for up to 30% of all injuries sustained in these sports. Despite established injury prevention strategies, the prevalence of recurrent lateral ankle sprain injuries and the concomitant development of CAI is high for athletes participating in indoor sports. CAI is characterized by athlete self-reported feelings of ankle joint instability, episodes of ankle joint "giving-way", and recurrent lateral ankle sprains. Additionally, athletes with CAI, who participate in indoor sports, may develop a heightened fear of re-injury, which may deter them from performing optimally in their sport. This study is designed as a prospective cohort study. The objective is to investigate fear of re-injury and ankle function in elite athletes with CAI (n = 25), both before and after a 10-week period during which they will use Spraino® during all training sessions and games. This study seeks to answer the following research questions: Does fear of re-injury improve in elite indoor sports athletes with established CAI when using Spraino® for 10 weeks? Does the use of Spraino® improve their ankle function?

The intervention time is scheduled for 10 weeks with the primary time point of interest being at the completion of week 10. The combined number of training sessions and games for each participant over the 10-week time-period is anticipated to exceed 32 exposures to ensure adequate exposure of participants to the use of Spraino®. All participants will receive a weekly text message using a Short Message Services-system (SMS-Track) throughout the 10-week time-period. This will be used to quantify training and game exposure and to register occurrences of new ankle injuries.

Embedded in this study is a qualitative method (semi-structured interview after week 10) to assess the participants´ experiences of using Spraino®. The content analysis will be a descriptive analysis of the data with some degree of interpretive analysis. The qualitative study will be reported in a secondary paper with a clear reference to this primary study registration.

The study purpose and methodology were evaluated by four identified stakeholders from the highest sports level including a physiotherapist, a head coach, a team doctor and an athlete. Their feedback ensured that the research is relevant to real-life circumstances and adds value to existing injury prevention strategies in elite indoor team sport.

The enrollment process will start in October 2018 and conclude when 25 participants have been enrolled in the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Fear of Re-injury and Ankle Function in Elite Athletes With Chronic Ankle Instability Using the Spraino® Shoe Patch: A Cohort Study
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Spraino intervention group
Participants will use Spraino® as a measure to prevent future lateral ankle sprains during all training sessions and games.
Device: Spraino
Spraino® is an adhesive polytetrafluoroethylene (PTFE or "Teflon") patch developed with the purpose of minimizing lateral shoe-surface friction whenever initial contact is carried out in an inverted position of the ankle joint. Each Spraino® PTFE patch has a minimum durability of 20 hours use and will be provided by the study sponsor, Spraino® ApS. The participants will receive four pairs of Spraino® upon their enrollment to the study.




Primary Outcome Measures :
  1. Fear of re-injury (Continuous) [ Time Frame: 10 weeks ]
    Fear of re-injury will be measured using a Numeric Rating Scale (NRS) from 0 to 100 with 10-point increments (e.g. by asking the participants: "How fearful are you of re-injuring your ankle?"), with lower scores indicating more fear of re-injury.


Secondary Outcome Measures :
  1. Y-balance test (Continuous) [ Time Frame: 10 weeks ]

    The athletes must maintain single-leg balance on one leg while reaching as far as possible with the contralateral leg in three different directions, including anterior, posteromedial and posterolateral performed on each leg. The test measures a reaching distance (normalized to percentage of the leg length) on the M.A.T (Movement Assessment Technologies) system.

    After completion of the test, three self-reported questions will be administered regarding pain, how confident and how stable the participants feel in their ankle. Score ranges from 0 (no pain/ fully confident/ fully stable) to 10 (worst possible pain/not at all confident/ not at all stable) on an 11-point NRS.


  2. The side-hop test (fastest time). (Continuous) [ Time Frame: 10 weeks ]

    The athletes must hop on one leg laterally and back again over a 30-cm distance (counted as one repetition). The test measures the time (seconds) it takes to complete 10 repetitions.

    After completion of the test, three self-reported questions will be administered regarding pain, how confident and how stable the participants feel in their ankle. Score ranges from 0 (no pain/ fully confident/ fully stable) to 10 (worst possible pain/not at all confident/ not at all stable) on an 11-point NRS.


  3. The Foot and Ankle Ability Measure (FAAM) sports scale [ Time Frame: 10 weeks ]
    The Foot and Ankle Ability Measure (FAAM) sports scale is an 8-item questionnaire designed to assess the level of ankle function in sports. Each item is scored on a five-point Likert scale from 4 to 0. Total scores can vary from 0 to 32, with higher scores representing higher levels of physical function.

  4. Tampa Scale of Kinesiophobia-11 (TSK-11) [ Time Frame: 10 weeks ]
    The Tampa Scale of Kinesiophobia-11 (TSK-11) is an 11-item questionnaire designed to assess fear of movement and re-injury. All items are based on a 4-point Likert scale in which athlete options range from strongly disagree to strongly agree. The TSK-11 scores range from 11 to 44, with higher scores indicating more kinesiophobia.

  5. Fear-Avoidance Beliefs Questionnaire (FABQ) [ Time Frame: 10 weeks ]
    The FABQ is a 16-item questionnaire designed to assess fear-avoidance beliefs. Each item is scored on a 7-point Likert scale from completely disagree to completely agree. The FABQ scores range from 0 to 66, with higher scores representing increased fear-avoidance beliefs.

  6. Time-loss due to an ankle sprain [ Time Frame: 10 weeks ]
    Time-loss (in days) due to an ankle sprain per athlete (continuous)

  7. The athlete experience with Spraino® (qualitative) [ Time Frame: 10 weeks ]
    Semi-structured interview regarding the participants´experiences from using Spraino® as preventative measure


Other Outcome Measures:
  1. Registration of adverse effects [ Time Frame: 10 weeks ]
    Adverse effects from using Spraino® (Binary) The participants will be encouraged to report occurrences of adverse events related to their use of Spraino® to the primary investigator. These events will be registered and reported to the Ethical Committee within seven days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is ≥ 18 years old at commencement of study.
  • Participant can read, speak and understand English.
  • Participant is playing in one of the two highest leagues in the following indoor sports: handball, volleyball and badminton with at least 32 training sessions during the study period.
  • Participant is diagnosed with CAI using the definition endorsed by the International Ankle Consortium.:

    • Participant has previously incurred at least one significant lateral ankle sprain that resulted in swelling, pain, and temporary loss of function at least 12 months prior to study enrollment.
    • Participant has a history of multiple episodes of the ankle ''giving-way'', and/or recurrent sprain and/or "feelings of instability" in the past six months
    • Participant has a Cumberland Ankle Instability Tool (CAIT) score <24
  • Participant can fully participate in training sessions and is eligible for game selection before enrollment in the study.
  • Participant can receive and reply to text messages on a cell phone using Short Message Services (SMS).

Exclusion Criteria:

  • History of medial ankle sprain
  • History of ankle surgery
  • Participant who does not agree to sign the informed consent to participate in the study

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): NCT03706729


Contacts
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Contact: Behnam Liaghat, MSc +4526826801 bliaghat@health.sdu.dk
Contact: Kristian Thorborg, PhD +4526271506 kristian.thorborg@regionh.dk

Locations
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Denmark
Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University Recruiting
Hvidovre, Denmark, 2650
Contact: Kristian Thorborg    +4526271506    kristian.thorborg@regionh.dk   
Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark Recruiting
Odense, Denmark, 5230
Contact: Behnam Liaghat    +4526826801    bliaghat@health.sdu.dk   
Sponsors and Collaborators
University of Southern Denmark
Copenhagen University Hospital, Hvidovre
Aalborg University
Metropolitan University College
Spraino
Investigators
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Principal Investigator: Behnam Liaghat, MSc Department of Sports Science & Clinical Biomechanics, University of Southern Denmark, Odense, Denmark
Study Director: Kristian Thorborg, PhD Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark
Study Chair: Thomas Q Bandholm, PhD Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark
Study Chair: Eamonn Delahunt, PhD School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland
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Responsible Party: Behnam Liaghat, Principal Investigator, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03706729    
Other Study ID Numbers: SprainoCohortStudy
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
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 Behnam Liaghat, University of Southern Denmark:
Ankle injury
Joint instability
Prevention and control
Elite athletes
Indoor Sports
Ligamentous sprain
Fear of re-injury
Additional relevant MeSH terms:
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Joint Instability
Joint Diseases
Musculoskeletal Diseases