Chronic Ankle InstabilityNCT03706729
Elite Athletes With Chronic Ankle Instability Using Spraino®: A Cohort Study
A study testing Spraino in people with Chronic Ankle Instability, run by University of Southern Denmark at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- Spraino
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2021to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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).
Who cannot join
- History of medial ankle sprain
- History of ankle surgery
- Participant who does not agree to sign the informed consent to participate in the study
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University
Hvidovre, 2650
Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark
Odense, 5230
About this study
Official title: Fear of Re-injury and Ankle Function in Elite Athletes With Chronic Ankle Instability Using the Spraino® Shoe Patch: A Cohort Study
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.
Read the detailed description
Acute lateral ankle sprains are frequently incurred by athletes, who participate in indoor sports such as volleyball, handball, and badminton; accounting for up to 30% of all injuries sustained in these sports. Despite established injury prevention strategies, the prevalence of recurrent lateral ankle sprain injuries and the concomitant development of CAI is high for athletes participating in indoor sports. CAI is characterized by athlete self-reported feelings of ankle joint instability, episodes of ankle joint "giving-way", and recurrent lateral ankle sprains. Additionally, athletes with CAI, who participate in indoor sports, may develop a heightened fear of re-injury, which may deter them from performing optimally in their sport. This study is designed as a prospective cohort study. The objective is to investigate fear of re-injury and ankle function in elite athletes with CAI (n = 25), both before and after a 10-week period during which they will use Spraino® during all training sessions and games. This study seeks to answer the following research questions: Does fear of re-injury improve in elite indoor sports athletes with established CAI when using Spraino® for 10 weeks? Does the use of Spraino® improve their ankle function?
The intervention time is scheduled for 10 weeks with the primary time point of interest being at the completion of week 10. The combined number of training sessions and games for each participant over the 10-week time-period is anticipated to exceed 32 exposures to ensure adequate exposure of participants to the use of Spraino®. All participants will receive a weekly text message using a Short Message Services-system (SMS-Track) throughout the 10-week time-period. This will be used to quantify training and game exposure and to register occurrences of new ankle injuries.
Embedded in this study is a qualitative method (semi-structured interview after week 10) to assess the participants´ experiences of using Spraino®. The content analysis will be a descriptive analysis of the data with some degree of interpretive analysis. The qualitative study will be reported in a secondary paper with a clear reference to this primary study registration.
The study purpose and methodology were evaluated by four identified stakeholders from the highest sports level including a physiotherapist, a head coach, a team doctor and an athlete. Their feedback ensured that the research is relevant to real-life circumstances and adds value to existing injury prevention strategies in elite indoor team sport.
The enrollment process will start in October 2018 and conclude when 25 participants have been enrolled in the study.
- Conditions
- Chronic Ankle Instability
- Being tested
- Spraino
- Keywords
- Ankle injury, Joint instability, Prevention and control, Elite athletes, Indoor Sports, Ligamentous sprain, Fear of re-injury
- Medical subject headings
- Ankle Injuries, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SprainoDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Spraino intervention group | Experimental | Participants will use Spraino® as a measure to prevent future lateral ankle sprains during all training sessions and games. Receives: Device: Spraino |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (7)
Y-balance test (Continuous)
The athletes must maintain single-leg balance on one leg while reaching as far as possible with the contralateral leg in three different directions, including anterior, posteromedial and posterolateral performed on each leg. The test measures a reaching distance (normalized to percentage of the leg length) on the M.A.T (Movement Assessment Technologies) system.
After completion of the test, three self-reported questions will be administered regarding pain, how confident and how stable the participants feel in their ankle. Score ranges from 0 (no pain/ fully confident/ fully stable) to 10 (worst possible pain/not at all confident/ not at all stable) on an 11-point NRS.
Measured: 10 weeks
The side-hop test (fastest time). (Continuous)
The athletes must hop on one leg laterally and back again over a 30-cm distance (counted as one repetition). The test measures the time (seconds) it takes to complete 10 repetitions.
After completion of the test, three self-reported questions will be administered regarding pain, how confident and how stable the participants feel in their ankle. Score ranges from 0 (no pain/ fully confident/ fully stable) to 10 (worst possible pain/not at all confident/ not at all stable) on an 11-point NRS.
Measured: 10 weeks
The Foot and Ankle Ability Measure (FAAM) sports scale
The Foot and Ankle Ability Measure (FAAM) sports scale is an 8-item questionnaire designed to assess the level of ankle function in sports. Each item is scored on a five-point Likert scale from 4 to 0. Total scores can vary from 0 to 32, with higher scores representing higher levels of physical function.
Measured: 10 weeks
Tampa Scale of Kinesiophobia-11 (TSK-11)
The Tampa Scale of Kinesiophobia-11 (TSK-11) is an 11-item questionnaire designed to assess fear of movement and re-injury. All items are based on a 4-point Likert scale in which athlete options range from strongly disagree to strongly agree. The TSK-11 scores range from 11 to 44, with higher scores indicating more kinesiophobia.
Measured: 10 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
The FABQ is a 16-item questionnaire designed to assess fear-avoidance beliefs. Each item is scored on a 7-point Likert scale from completely disagree to completely agree. The FABQ scores range from 0 to 66, with higher scores representing increased fear-avoidance beliefs.
Measured: 10 weeks
Time-loss due to an ankle sprain
Time-loss (in days) due to an ankle sprain per athlete (continuous)
Measured: 10 weeks
The athlete experience with Spraino® (qualitative)
Semi-structured interview regarding the participants´experiences from using Spraino® as preventative measure
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study startMay 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: Due to Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, Aalborg University, Metropolitan University College, Spraino
- Responsible party
- Principal investigator, Behnam Liaghat, University of Southern Denmark
- Investigators
- Behnam Liaghat, MSc, Principal investigator, Department of Sports Science & Clinical Biomechanics, University of Southern Denmark, Odense, DenmarkKristian Thorborg, PhD, Study director, Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, DenmarkThomas Q Bandholm, PhD, Study chair, Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, DenmarkEamonn Delahunt, PhD, Study chair, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706729
- Sponsor's protocol ID
- SprainoCohortStudy
- Status last verified
- May 2022
- First submitted
- 11 Oct 2018
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear of Re-injury and Ankle Function in Elite Athletes With Chronic Ankle Instability Using the Spraino® Shoe Patch: A Cohort Study
- ClinicalTrials.gov ID
- NCT03706729
- Acronym / sponsor ID
- SprainoCohortStudy
- Conditions
- Chronic Ankle Instability
- Keywords
- Ankle injury, Joint instability, Prevention and control, Elite athletes, Indoor Sports, Ligamentous sprain, Fear of re-injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to Covid-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, Aalborg University, Metropolitan University College, Spraino
- Study start
- May 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute lateral ankle sprains are frequently incurred by athletes, who participate in indoor sports such as volleyball, handball, and badminton; accounting for up to 30% of all injuries sustained in these sports. Despite established injury prevention strategies, the prevalence of recurrent lateral ankle sprain injuries and the concomitant development of CAI is high for athletes participating in indoor sports. CAI is characterized by athlete self-reported feelings of ankle joint instability, episodes of ankle joint "giving-way", and recurrent lateral ankle sprains. Additionally, athletes with CAI, who participate in indoor sports, may develop a heightened fear of re-injury, which may deter them from performing optimally in their sport. This study is designed as a prospective cohort study. The objective is to investigate fear of re-injury and ankle function in elite athletes with CAI (n = 25), both before and after a 10-week period during which they will use Spraino® during all training sessions and games. This study seeks to answer the following research questions: Does fear of re-injury improve in elite indoor sports athletes with established CAI when using Spraino® for 10 weeks? Does the use of Spraino® improve their ankle function?
The intervention time is scheduled for 10 weeks with the primary time point of interest being at the completion of week 10. The combined number of training sessions and games for each participant over the 10-week time-period is anticipated to exceed 32 exposures to ensure adequate exposure of participants to the use of Spraino®. All participants will receive a weekly text message using a Short Message Services-system (SMS-Track) throughout the 10-week time-period. This will be used to quantify training and game exposure and to register occurrences of new ankle injuries.
Embedded in this study is a qualitative method (semi-structured interview after week 10) to assess the participants´ experiences of using Spraino®. The content analysis will be a descriptive analysis of the data with some degree of interpretive analysis. The qualitative study will be reported in a secondary paper with a clear reference to this primary study registration.
The study purpose and methodology were evaluated by four identified stakeholders from the highest sports level including a physiotherapist, a head coach, a team doctor and an athlete. Their feedback ensured that the research is relevant to real-life circumstances and adds value to existing injury prevention strategies in elite indoor team sport.
The enrollment process will start in October 2018 and conclude when 25 participants have been enrolled in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spraino intervention group | Experimental | Device: SprainoParticipants will use Spraino® as a measure to prevent future lateral ankle sprains during all training sessions and games. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 can fully participate in training sessions and is eligible for game selection before enrollment in the study.
Key exclusion criteria (3 listed)
- History of medial ankle sprain
- History of ankle surgery
- Participant who does not agree to sign the informed consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SprainoSpraino® 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. | Device | Spraino intervention group |
Primary outcome
Fear of re-injury (Continuous)
Time frame: 10 weeks
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.
7 secondary outcomes
Y-balance test (Continuous)
Time frame: 10 weeks
The side-hop test (fastest time). (Continuous)
Time frame: 10 weeks
The Foot and Ankle Ability Measure (FAAM) sports scale
Time frame: 10 weeks
Tampa Scale of Kinesiophobia-11 (TSK-11)
Time frame: 10 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: 10 weeks
Time-loss due to an ankle sprain
Time frame: 10 weeks
The athlete experience with Spraino® (qualitative)
Time frame: 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Behnam Liaghat, MSc principal investigator
Department of Sports Science & Clinical Biomechanics, University of Southern Denmark, Odense, Denmark
Kristian Thorborg, PhD study director
Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark
Thomas Q Bandholm, PhD study chair
Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spraino in people with Chronic Ankle Instability, run by University of Southern Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of re-injury (Continuous) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.