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

NCT04742088 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-09-14

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • EFOR, France

    collaborator INDUSTRY

  • Decathlon SE

    lead INDUSTRY

Principal Investigators

  • Valérie WIECZOREK · Centre Hospitalier Universitaire de Lille

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-17
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742088 on ClinicalTrials.gov