Sponsor study identifier
interventional
30
1 country
4
Study Start
March 17, 2021
Actual (reported)Primary Completion
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 4, 2020
Actual (reported)February 5, 2021
Actual (reported)March 17, 2021
Actual (reported)May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Confidence level
At baseline and 6 weeks of follow-up
Ankle instability
At 2 weeks and 6 weeks of follow-up
Ankle pain
At 2 weeks and 6 weeks of follow-up
Safety (adverse events)
6 weeks of follow-up
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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centre de rééducation et de balnéothérapie Kinés Faches
Faches-Thumesnil, 59155, France
Centre Hospitalier Universitaire de Lille
Lille, 59000, France
Cabinet de kinésithérapie du Belvédère
Paris, 75019, France
Valérie WIECZOREK
Centre Hospitalier Universitaire de Lille
First Submitted
September 4, 2020
First Posted
February 5, 2021
Study Start
March 17, 2021
Actual (reported)Primary Completion
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
KOSS Paris 8
Paris, France
Study Completion
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 14, 2022
Record last verified: 2022-09
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Source: ClinicalTrials.gov.
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