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

NCT03706729 | Withdrawn DMC

• 1 other identifier: SprainoCohortStudy
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Ankle Instability

Keywords

Ankle injury; Joint instability; Prevention and control; Elite athletes; Indoor Sports; Ligamentous sprain; Fear of re-injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Y-balance test (Continuous)

  10 weeks

• The side-hop test (fastest time). (Continuous)

  10 weeks

• The Foot and Ankle Ability Measure (FAAM) sports scale

  10 weeks

• Tampa Scale of Kinesiophobia-11 (TSK-11)

  10 weeks

• Fear-Avoidance Beliefs Questionnaire (FABQ)

  10 weeks

Other Outcomes (1)

• Registration of adverse effects

  10 weeks

Study Arms (1)

Spraino intervention group

EXPERIMENTAL

Participants will use Spraino® as a measure to prevent future lateral ankle sprains during all training sessions and games.

Device: Spraino

Interventions

Spraino DEVICE

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.

Spraino intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Copenhagen University Hospital, Hvidovre: collaborator
• Aalborg University: collaborator
• Metropolitan University College: collaborator
• Spraino: collaborator

Study Sites (2)

Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University

Hvidovre, 2650, Denmark

Location

Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark

Odense, 5230, Denmark

Location

MeSH Terms

Conditions

Ankle Injuries; Joint Instability

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Behnam Liaghat, MSc

  Department of Sports Science & Clinical Biomechanics, University of Southern Denmark, Odense, Denmark

  PRINCIPAL INVESTIGATOR

• Kristian Thorborg, PhD

  Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: May 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

DK (2)