Chronic Pain Clinical Trial
Official title:
Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports Practice
NCT number | NCT04742088 |
Other study ID # | ankleSOFT100 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 17, 2021 |
Est. completion date | May 2023 |
Verified date | September 2022 |
Source | Decathlon SE |
Contact | Jean HEE |
Phone | XX XX XX XX XX |
jean.hee[@]btwin.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | May 2023 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre de rééducation et de balnéothérapie Kinés Faches | Faches-Thumesnil | |
France | Centre Hospitalier Universitaire de Lille | Lille | |
France | Cabinet de kinésithérapie du Belvédère | Paris | |
France | KOSS Paris 8 | Paris |
Lead Sponsor | Collaborator |
---|---|
Decathlon SE | EFOR, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional score | Change from baseline functional result (Cumberland Ankle Instability Tool: 0-30 points) at 6 weeks | At baseline and 6 weeks of follow-up | |
Secondary | 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 | At baseline and 6 weeks of follow-up | |
Secondary | 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) | At 2 weeks and 6 weeks of follow-up | |
Secondary | 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) | At 2 weeks and 6 weeks of follow-up | |
Secondary | Safety (adverse events) | Rate of adverse events occurred during the study | 6 weeks of follow-up |
Status | Clinical Trial | Phase | |
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