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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04742088
Other study ID # ankleSOFT100
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 17, 2021
Est. completion date May 2023

Study information

Verified date September 2022
Source Decathlon SE
Contact Jean HEE
Phone XX XX XX XX XX
Email jean.hee@btwin.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 2023
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ankleSOFT100
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)

Locations

Country Name City State
France 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

Sponsors (2)

Lead Sponsor Collaborator
Decathlon SE EFOR, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary Safety (adverse events) Rate of adverse events occurred during the study 6 weeks of follow-up
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