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

Chronic Ankle Instability Clinical Trial

Official title:

Fear of Re-injury and Ankle Function in Elite Athletes With Chronic Ankle Instability Using the Spraino® Shoe Patch: A Cohort Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03706729
• Other study ID #: SprainoCohortStudy
• Status: Withdrawn
• Phase: N/A
• Start date: May 2021
• Est. completion date: September 2021

Study information

• Verified date: May 2022
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Ankle Instability
• Joint Instability

Intervention

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.

Locations

Country	Name	City	State
Denmark	Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University	Hvidovre
Denmark	Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark	Odense

Sponsors (5)

Lead Sponsor	Collaborator
University of Southern Denmark	Aalborg University, Copenhagen University Hospital, Hvidovre, Metropolitan University College, Spraino

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Registration of adverse effects	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
Primary	Fear of re-injury (Continuous)	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	Y-balance test (Continuous)	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
Secondary	The side-hop test (fastest time). (Continuous)	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
Secondary	The Foot and Ankle Ability Measure (FAAM) sports scale	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
Secondary	Tampa Scale of Kinesiophobia-11 (TSK-11)	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
Secondary	Fear-Avoidance Beliefs Questionnaire (FABQ)	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
Secondary	Time-loss due to an ankle sprain	Time-loss (in days) due to an ankle sprain per athlete (continuous)	10 weeks
Secondary	The athlete experience with Spraino® (qualitative)	Semi-structured interview regarding the participants´experiences from using Spraino® as preventative measure	10 weeks