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| Name | Class |
|---|---|
| EFOR, France | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthosis group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ankleSOFT100 | Device | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Non-inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean HEE | Contact | XX XX XX XX XX | jean.hee@btwin.com |
| Name | Affiliation | Role |
|---|---|---|
| Valérie WIECZOREK | Centre Hospitalier Universitaire de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de rééducation et de balnéothérapie Kinés Faches | Active, not recruiting | Faches-Thumesnil | 59155 | France | ||
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| Centre Hospitalier Universitaire de Lille |
| Recruiting |
| Lille |
| 59000 |
| France |
|
| Cabinet de kinésithérapie du Belvédère | Not yet recruiting | Paris | 75019 | France |
|
| KOSS Paris 8 | Terminated | Paris | France |