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Trial record 45 of 345 for:    sprains and strains

The Spraino Pilot Trial

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ClinicalTrials.gov Identifier: NCT03311490
Recruitment Status : Terminated (The decision to halt the trial in October was made in June, as the anticipated no. of events(ankle sprains) required for the analyses was almost reached in June)
First Posted : October 17, 2017
Last Update Posted : October 9, 2018
Sponsor:
Collaborators:
Copenhagen University Hospital, Hvidovre
Aalborg University
Metropolitan University College
The Copenhagen Center for Health Technology (CACHET)
Information provided by (Responsible Party):
Spraino

Brief 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.


Condition or disease Intervention/treatment Phase
Athletes With Previous Lateral Ankle Sprain(s) Device: Spraino Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : October 19, 2017
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : October 5, 2018

Arm Intervention/treatment
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®.



Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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)

  4. 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.


  5. 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.


  6. 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)

  7. 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.


  8. 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.


  9. 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)

  10. 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.


  11. 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.


  12. 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)

  13. 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.



Other Outcome Measures:
  1. 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.


  2. 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)


  3. 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)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311490


Locations
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Denmark
Physical Activity and Human Performance, Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, Denmark
Aalborg, Denmark, 9220
Physical Medicine and Rehabilitation Research—Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Spraino
Copenhagen University Hospital, Hvidovre
Aalborg University
Metropolitan University College
The Copenhagen Center for Health Technology (CACHET)
Investigators
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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

Additional Information:
Publications:
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Responsible Party: Spraino
ClinicalTrials.gov Identifier: NCT03311490     History of Changes
Other Study ID Numbers: 4559
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Spraino:
Ankle Sprain
Prophylaxis
Indoor Sports
Ligamentous sprain
Prevention

Additional relevant MeSH terms:
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Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries