Athletes With Previous Lateral Ankle Sprain(s) Clinical Trial
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)
NCT number | NCT03311490 |
Other study ID # | 4559 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | October 19, 2017 |
Est. completion date | October 5, 2018 |
Verified date | August 2019 |
Source | Spraino |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 510 |
Est. completion date | October 5, 2018 |
Est. primary completion date | October 5, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Physical Activity and Human Performance, Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, Denmark | Aalborg | |
Denmark | Physical Medicine and Rehabilitation Research—Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Spraino | Aalborg University, Copenhagen University Hospital, Hvidovre, Metropolitan University College, The Copenhagen Center for Health Technology (CACHET) |
Denmark,
Bandholm T, Christensen R, Thorborg K, Treweek S, Henriksen M. Preparing for what the reporting checklists will not tell you: the PREPARE Trial guide for planning clinical research to avoid research waste. Br J Sports Med. 2017 Oct;51(20):1494-1501. doi: 10.1136/bjsports-2017-097527. Epub 2017 Sep 7. — View Citation
Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse effects from using Spraino® | 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 | |
Other | Fear of re-injury | 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 | |
Other | Ankle pain | 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 | |
Primary | Lateral ankle sprains | 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 | |
Primary | First-time non-contact lateral ankle sprains | 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 | |
Primary | Time-loss due to first-time non-contact lateral ankle sprains | Time-loss (in number of weeks) due to first-time non-contact lateral ankle sprains per athlete (continuous) | 52 weeks | |
Primary | Severe first-time non-contact lateral ankle sprains | 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 | |
Primary | Recurrent non-contact lateral ankle sprains | 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 | |
Primary | Time-loss due to recurrent non-contact lateral ankle sprains | Time-loss (in number of weeks) due to recurrent non-contact lateral ankle sprains per athlete (continuous) | 52 weeks | |
Primary | Severe recurrent non-contact lateral ankle sprains | 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 | |
Primary | First-time lateral ankle sprains | 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 | |
Primary | Time-loss due to first-time lateral ankle sprains | Time-loss (in number of weeks) due to first-time lateral ankle sprains per athlete (continuous) | 52 weeks | |
Primary | Severe first-time lateral ankle sprains | 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 | |
Primary | Recurrent lateral ankle sprains | 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 | |
Primary | Time-loss due to recurrent lateral ankle sprains | Time-loss (in number of weeks) due to recurrent lateral ankle sprains per athlete (continuous) | 52 weeks | |
Primary | Severe recurrent lateral ankle sprains | 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 |