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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04742088
• Other study ID #: ankleSOFT100
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Instability of Ankle Joint
• Chronic Pain

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