Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports Practice

Not Applicable

Recruiting

• Conditions: Chronic Pain; Chronic Instability of Ankle Joint

• Registration Number: NCT04742088
• Lead Sponsor: Decathlon SE

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-05
• Study Start: 2021-03-17
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-14
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Functional score	At baseline and 6 weeks of follow-up	Change from baseline functional result (Cumberland Ankle Instability Tool: 0-30 points) at 6 weeks

Secondary Outcome Measures

Name	Time	Method
Ankle pain	At 2 weeks and 6 weeks of follow-up	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)
Safety (adverse events)	6 weeks of follow-up	Rate of adverse events occurred during the study
Confidence level	At baseline and 6 weeks of follow-up	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
Ankle instability	At 2 weeks and 6 weeks of follow-up	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)

Trial Locations

Locations (4)

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, France