- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03706729
Elite Athletes With Chronic Ankle Instability Using Spraino®: A Cohort Study
Fear of Re-injury and Ankle Function in Elite Athletes With Chronic Ankle Instability Using the Spraino® Shoe Patch: A Cohort Study
Study Overview
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hvidovre, Denmark, 2650
- Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University
-
Odense, Denmark, 5230
- Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
10 weeks
|
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. |
10 weeks
|
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.
|
10 weeks
|
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.
|
10 weeks
|
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.
|
10 weeks
|
Time-loss due to an ankle sprain
Time Frame: 10 weeks
|
Time-loss (in days) due to an ankle sprain per athlete (continuous)
|
10 weeks
|
The athlete experience with Spraino® (qualitative)
Time Frame: 10 weeks
|
Semi-structured interview regarding the participants´experiences from using Spraino® as preventative measure
|
10 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
- Principal Investigator: Behnam Liaghat, MSc, Department of Sports Science & Clinical Biomechanics, University of Southern Denmark, Odense, Denmark
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SprainoCohortStudy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Ankle Instability
-
Gwendolyn VuurbergZimmer Biomet; Albert Schweitzer Hospital; Centro Hospitalar do Porto; Amphia Hospital and other collaboratorsRecruitingChronic Ankle InstabilityNetherlands, Portugal, Switzerland
-
University of North Carolina, Chapel HillAcademy of Orthopaedic Physical TherapyCompletedChronic Ankle InstabilityUnited States
-
Linnaeus UniversityCompletedChronic Ankle InstabilitySweden
-
Yeditepe UniversityCompleted
-
Istanbul Gelisim UniversityCompleted
-
National Yang Ming UniversityCompletedChronic Ankle InstabilityTaiwan
-
Cairo UniversityCompletedChronic Ankle Instability
-
University of VirginiaCompleted
-
Chonbuk National University HospitalCompletedChronic Ankle InstabilityKorea, Republic of
-
University GhentCompletedChronic Ankle InstabilityBelgium
Clinical Trials on Spraino
-
SprainoAalborg University; Copenhagen University Hospital, Hvidovre; Metropolitan University... and other collaboratorsTerminated