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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain, Chronic Instability of Ankle Joint

Intervention / Treatment
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* Device: ankleSOFT100


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orthosis group<br> | Device: ankleSOFT100<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Safety (adverse events) | Rate of adverse events occurred during the study | 6 weeks of follow-up |