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

N/AUnknownNCT04742088

Decathlon SE30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Chronic Pain Chronic Instability of Ankle Joint

Interventions

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Centre de rééducation et de balnéothérapie Kinés Faches

Faches-Thumesnil, France

ACTIVE_NOT_RECRUITING

Centre Hospitalier Universitaire de Lille

Lille, France

RECRUITING

Cabinet de kinésithérapie du Belvédère

Paris, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Functional score

Change from baseline functional result (Cumberland Ankle Instability Tool: 0-30 points) at 6 weeks

Time frame: At baseline and 6 weeks of follow-up

Secondary Outcomes

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

Time frame: 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)

Time frame: 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)

Time frame: At 2 weeks and 6 weeks of follow-up

Safety (adverse events)

Rate of adverse events occurred during the study

Time frame: 6 weeks of follow-up

Central Contacts

Jean HEE

CONTACT

XX XX XX XX XX jean.hee@btwin.com

Data from ClinicalTrials.gov

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