Status:
UNKNOWN
Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports Practice
Lead Sponsor:
Decathlon SE
Collaborating Sponsors:
EFOR, France
Conditions:
Chronic Pain
Chronic Instability of Ankle Joint
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04742088
Start Date
March 17 2021
End Date
May 1 2023
Last Update
September 14 2022
Active Locations (4)
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1
Centre de rééducation et de balnéothérapie Kinés Faches
Faches-Thumesnil, France, 59155
2
Centre Hospitalier Universitaire de Lille
Lille, France, 59000
3
Cabinet de kinésithérapie du Belvédère
Paris, France, 75019
4
KOSS Paris 8
Paris, France