The Spraino Pilot Trial

Summary

This pilot study will establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level, with a one-year follow-up.

All recruited participants will have a history of lateral ankle sprain in the preceding 24 months prior to the initiation of the trial. Half of the included participants will receive Spraino® to prevent lateral ankle sprains (intervention group). The other half will receive no intervention ("do-as-usual" control group). Both groups will be permitted to continue or initiate any usual care of their choice, except Spraino® in the control group. Short Message Services (SMS) will be used for registration of injury and exposure.

Conditions

• Athletes With Previous Lateral Ankle Sprain(s)

Interventions

DEVICE

Spraino

Participants allocated to the intervention group will use Spraino® as a measure to prevent future lateral ankle sprains during all on-court practice sessions and matches. Spraino® is an adhesive polytetrafluoroethylene (PTFE or "Teflon") patch. It is developed with the intent 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 trial sponsor, Spraino® ApS. The participants allocated to the intervention group will receive four pairs of the Spraino® patches via postal service or by hand delivery on a monthly basis, or upon request if material is worn out prematurely during the 52-week trial period.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre

  collaborator OTHER

• Aalborg University

  collaborator OTHER

• Metropolitan University College

  collaborator OTHER

• The Copenhagen Center for Health Technology (CACHET)

  collaborator UNKNOWN

• Spraino

  lead INDUSTRY

Principal Investigators

• Filip G Lysdal, MSc · Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, 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

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-10-19

Primary Completion

2018-10-05

Completion

2018-10-05

Countries

• Denmark

Study Locations