Chronic Instability of Ankle Joint, Chronic Pain
Conditions
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.
Interventions
DEVICEankleSOFT100
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)
Sponsors
EFOR, France
Decathlon SE
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Countries
France
Contacts
Primary ContactJean HEE
Outcome results
None listed