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

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.

Conditions

• Chronic Ankle Instability

Interventions

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.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre

  collaborator OTHER

• Aalborg University

  collaborator OTHER

• Metropolitan University College

  collaborator OTHER

• Spraino

  collaborator INDUSTRY

• University of Southern Denmark

  lead OTHER

Principal Investigators

• Behnam Liaghat, MSc · Department of Sports Science & Clinical Biomechanics, University of Southern Denmark, Odense, Denmark

• Kristian Thorborg, PhD · Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark

• Thomas Q Bandholm, PhD · Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark

• Eamonn Delahunt, PhD · School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-31

Primary Completion

2021-09-30

Completion

2021-09-30

Countries

• Denmark

Study Locations