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

NCT04742088 | Unknown

• 1 other identifier: ankleSOFT100
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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

Chronic Pain; Chronic Instability of Ankle Joint

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Orthosis group

EXPERIMENTAL

Device: ankleSOFT100

Interventions

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)

Orthosis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Decathlon SE: lead
• EFOR, France: collaborator

Study Sites (4)

Centre de rééducation et de balnéothérapie Kinés Faches

Faches-Thumesnil, 59155, France

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

RECRUITING

Cabinet de kinésithérapie du Belvédère

Paris, 75019, France

NOT YET RECRUITING

KOSS Paris 8

Paris, France

TERMINATED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valérie WIECZOREK

  Centre Hospitalier Universitaire de Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean HEE

CONTACT

XX XX XX XX XX; jean.hee@btwin.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: February 5, 2021
• Study Start: March 17, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)