The Spraino Pilot Trial

August 29, 2019 updated by: Spraino

A Randomized Pilot Trial to Evaluate the Preliminary Effect and Safety of Using Spraino® to Prevent Lateral Ankle Sprains in Indoor Sports (The Spraino Pilot Trial)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this exploratory trial (named "The Spraino Pilot Trial") is to establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level (handball, basketball, floorball and badminton) when compared to a "do-as-usual" control group.

It is a randomized controlled pilot trial (Pilot-RCT) with a two-group parallel design and blinded outcome assessment. The trial will include prospective injury and exposure registration using a Short Message Services-system (SMS-Track) throughout a 52-week follow-up period (one calendar year).

It is anticipated that 500 participants, which approximates to 250 in each group, will be enrolled in the trial. The enrollment process will cease when at least 250 participants have been allocated to the intervention group. Only athletes participating in indoor sports with a history of a lateral ankle sprain in the preceding 24 months are eligible for inclusion in the trial. The participants will be randomized (1:1 allocation ratio) using numbered lots. The randomization process will ensure stratification for gender, sports discipline and level of play.

A full trial protocol, based on the "SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials" (Chan et al., 2013) and the "PREPARE Trial guide" (Bandholm et al., 2017), will be published and made publicly available. The trial report will adhere to the CONSORT 2010 statement, using the extension for randomized pilot and feasibility trials.

Being an exploratory pilot trial, the study is designed with a flat outcome structure with multiple evenly valued outcome measures. Thus, no primary and secondary outcome measure hierarchy exists.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
510

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9220
        • Physical Activity and Human Performance, Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, Denmark
      • Hvidovre, Denmark, 2650
        • Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant is ≥ 18 years old at commencement of trial.
  • Participant can read, speak and understand Danish.
  • Participant can receive and reply to texts on a cell phone using Short Message Services (SMS).
  • Participant performs indoor sports (Handball, basketball, floorball orbadminton) in a sub-elite level team with ≥ 2 weekly practice sessions.
  • Participant has incurred ≥ 1 lateral ankle sprain injury in the preceding 24 months.
  • Participant has returned to play at commencement of the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Participants allocated to the intervention group will use Spraino® as a measure to prevent lateral ankle sprains.
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.
No Intervention: Control
Participants allocated to the control group will be a "do-as-usual" comparator. This implies, that the participants can treat and prevent lateral ankle sprains in any way they wish, except using Spraino®.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lateral ankle sprains
Time Frame: 52 weeks

Rate of lateral ankle sprains (continuous)

The incidence rate is defined as the number of lateral ankle sprains per 1000 hours of exposure.
52 weeks
First-time non-contact lateral ankle sprains
Time Frame: 52 weeks

Rate of first-time non-contact lateral ankle sprains (continuous)

The incidence rate is defined as the number of first-time non-contact lateral ankle sprains per 1000 hours of exposure.
52 weeks
Time-loss due to first-time non-contact lateral ankle sprains
Time Frame: 52 weeks
Time-loss (in number of weeks) due to first-time non-contact lateral ankle sprains per athlete (continuous)
52 weeks
Severe first-time non-contact lateral ankle sprains
Time Frame: 52 weeks

Rate of severe first-time non-contact lateral ankle sprains (continuous)

The incidence rate is defined as the number of severe first-time non-contact lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
52 weeks
Recurrent non-contact lateral ankle sprains
Time Frame: 52 weeks

Rate of recurrent non-contact lateral ankle sprains (continuous)

The incidence rate is defined as the number of recurrent non-contact lateral ankle sprains per 1000 hours of exposure.
52 weeks
Time-loss due to recurrent non-contact lateral ankle sprains
Time Frame: 52 weeks
Time-loss (in number of weeks) due to recurrent non-contact lateral ankle sprains per athlete (continuous)
52 weeks
Severe recurrent non-contact lateral ankle sprains
Time Frame: 52 weeks

Rate of severe recurrent non-contact lateral ankle sprains (continuous)

The incidence rate is defined as the number of severe recurrent non-contact lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
52 weeks
First-time lateral ankle sprains
Time Frame: 52 weeks

Rate of first-time lateral ankle sprains (continuous)

The incidence rate is defined as the summation of both contact and non-contact first-time lateral ankle sprains per 1000 hours of exposure.
52 weeks
Time-loss due to first-time lateral ankle sprains
Time Frame: 52 weeks
Time-loss (in number of weeks) due to first-time lateral ankle sprains per athlete (continuous)
52 weeks
Severe first-time lateral ankle sprains
Time Frame: 52 weeks

Rate of severe first-time lateral ankle sprains (continuous)

The incidence rate is defined as the number of severe first-time lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
52 weeks
Recurrent lateral ankle sprains
Time Frame: 52 weeks

Rate of recurrent lateral ankle sprains (continuous)

The incidence rate is defined as the summation of both contact and non-contact recurrent lateral ankle sprains per 1000 hours of exposure.
52 weeks
Time-loss due to recurrent lateral ankle sprains
Time Frame: 52 weeks
Time-loss (in number of weeks) due to recurrent lateral ankle sprains per athlete (continuous)
52 weeks
Severe recurrent lateral ankle sprains
Time Frame: 52 weeks

Rate of severe recurrent lateral ankle sprains (continuous)

The incidence rate is defined as the number of severe recurrent lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
52 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse effects from using Spraino®
Time Frame: 52 weeks

Reports of adverse events in the intervention group (binary)

All adverse events will be registered while the participants are enrolled in the trial. Adverse events will be reported as type and number of events. The included participants will be encouraged to report any adverse events related to the use of Spraino® to the trial hotline.
52 weeks
Fear of re-injury
Time Frame: 52 weeks

Fear of lateral ankle sprain re-injury (continuous)

Change in fear of re-injury from pre- to post-trial intervention period. Fear of re-injury is scored on a numeric rating scale from 0 - 100 (0 = Extremely fear full, 100 = No fear at all)
52 weeks
Ankle pain
Time Frame: 52 weeks

Ankle pain (continuous)

Change in ankle pain from pre- to post-trial intervention period. Ankle pain is scored on a numeric rating scale from 0 - 10 (0 = No pain at all, 10 = Extremely painful)
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spraino

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aalborg University
Copenhagen University Hospital, Hvidovre
Metropolitan University College
The Copenhagen Center for Health Technology (CACHET)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Filip G Lysdal, MSc, Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, Denmark
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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