Chronic PainNCT04742088
Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports Practice
A study testing ankleSOFT100 in people with Chronic Pain and Chronic Instability of Ankle Joint, run by Decathlon SE at 4 sites in France.
Trial summary
Decathlon has developed ankleSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon ankleSOFT100 product to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Chronic Instability of Ankle Joint
- What is being tested?
- ankleSOFT100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesFrance
- Study dates
- 17 Mar 2021to May 2023
- 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
- Subject is aged ≥18 years old
- Subject has chronic pain AND / OR chronic ankle instability
- The current condition of his/her ankle allows the subject to pursue a usual physical activity
- Subject has been informed and is willing to sign an informed consent form
- Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
- Subject is affiliated to the French social security regime
Show all 12Show fewer
- Non-inclusion Criteria:
- Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
- Subject has worn a support (ankle brace or articulated orthosis) during sports sessions during the last month
- Subject has any medical condition that could impact the study at investigator's discretion
- Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, elastane, polyester, synthetic rubber)
- Adult subject to a legal protection measure
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
France4 sites, 2 recruiting
- Active, not recruiting
Centre de rééducation et de balnéothérapie Kinés Faches
Faches-Thumesnil, 59155
- Recruiting
Centre Hospitalier Universitaire de Lille
Lille, 59000
Valérie WIECZOREK
Valérie WIECZOREK
- Not yet recruiting
Cabinet de kinésithérapie du Belvédère
Paris, 75019
Charlotte QUATRHOMME
Charlotte QUATRHOMME
- Terminated
KOSS Paris 8
Paris
About this study
Decathlon has developed ankleSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon ankleSOFT100 product to demonstrate safety and performance of this device in a real-world setting.
- Conditions
- Chronic Pain, Chronic Instability of Ankle Joint
- Being tested
- ankleSOFT100
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ankleSOFT100Device
During the first two weeks of follow-up, the subject shall not use the device during the sports sessions. The subject shall use the device during the sports sessions for the next 4 weeks (6 weeks of follow-up)
| Study group | Role | What they receive |
|---|---|---|
| Orthosis group | Experimental | Not described Receives: Device: ankleSOFT100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional score
Change from baseline functional result (Cumberland Ankle Instability Tool: 0-30 points) at 6 weeks
Measured: At baseline and 6 weeks of follow-up
Secondary outcomes (4)
Confidence level
Gap in the confidence level (patient rated outcome with 6 questions, ranging from 0 to 100) related to physical activity, between the baseline and last follow-up visit
Measured: At baseline and 6 weeks of follow-up
Ankle instability
Comparison of ankle instability between the first two weeks of follow-up (without use of the device during sports sessions) and the following four weeks (with use of the device during sports sessions), measured through a Numerical Rating Scale (NRS, ranging from 0 to 10)
Measured: At 2 weeks and 6 weeks of follow-up
Ankle pain
Comparison of ankle pain between the first two weeks of follow-up (without use of the device during sports sessions) and the following four weeks (with use of the device during sports sessions), measured through a NRS (ranging from 0 to 10)
Measured: At 2 weeks and 6 weeks of follow-up
Safety (adverse events)
Rate of adverse events occurred during the study
Measured: 6 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start17 Mar 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Decathlon SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EFOR, France
- Responsible party
- Sponsor
- Investigators
- Valérie WIECZOREK, Principal investigator, Centre Hospitalier Universitaire de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742088
- Sponsor's protocol ID
- ankleSOFT100
- Status last verified
- Sep 2022
- First submitted
- 4 Sep 2020
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports Practice
- ClinicalTrials.gov ID
- NCT04742088
- Acronym / sponsor ID
- ankleSOFT100
- Conditions
- Chronic Pain, Chronic Instability of Ankle Joint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Decathlon SEIndustry (pharma, biotech, devices)
- Collaborators
- EFOR, France
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 5 Feb 2021 (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.
Decathlon has developed ankleSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon ankleSOFT100 product to demonstrate safety and performance of this device in a real-world setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthosis group | Experimental | Device: ankleSOFT100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is aged ≥18 years old
- Subject has chronic pain AND / OR chronic ankle instability
- The current condition of his/her ankle allows the subject to pursue a usual physical activity
- Subject has been informed and is willing to sign an informed consent form
- Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ankleSOFT100During the first two weeks of follow-up, the subject shall not use the device during the sports sessions. The subject shall use the device during the sports sessions for the next 4 weeks (6 weeks of follow-up) | Device | Orthosis group |
Primary outcome
Functional score
Time frame: At baseline and 6 weeks of follow-up
Change from baseline functional result (Cumberland Ankle Instability Tool: 0-30 points) at 6 weeks
4 secondary outcomes
Confidence level
Time frame: At baseline and 6 weeks of follow-up
Ankle instability
Time frame: At 2 weeks and 6 weeks of follow-up
Ankle pain
Time frame: At 2 weeks and 6 weeks of follow-up
Safety (adverse events)
Time frame: 6 weeks of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Valérie WIECZOREK principal investigator
Centre Hospitalier Universitaire de Lille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ankleSOFT100 in people with Chronic Pain and Chronic Instability of Ankle Joint, run by Decathlon SE at 4 sites in France.
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 12 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean HEE (XX XX XX XX XX, jean.hee@btwin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional score (time frame: At baseline and 6 weeks of follow-up). 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 14 Sep 2022.