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

Primary Purpose

Chronic Pain, Chronic Instability of Ankle Joint

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

ankleSOFT100

About this trial

This is an interventional supportive care trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre de rééducation et de balnéothérapie Kinés Faches
Centre Hospitalier Universitaire de LilleRecruiting
Cabinet de kinésithérapie du Belvédère
KOSS Paris 8

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Orthosis group

Arm Description

Outcomes

Primary Outcome Measures

Functional score

Change from baseline functional result (Cumberland Ankle Instability Tool: 0-30 points) at 6 weeks

Secondary Outcome Measures

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

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)

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)

Safety (adverse events)

Rate of adverse events occurred during the study

Full Information

NCT ID

NCT04742088

First Posted

September 4, 2020

Last Updated

September 12, 2022

Sponsor

Decathlon SE

Collaborators

EFOR, France

1. Study Identification

Unique Protocol Identification Number

NCT04742088

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 17, 2021 (Actual)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Decathlon SE

Collaborators

EFOR, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Chronic Instability of Ankle Joint

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Orthosis group

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

ankleSOFT100

Intervention Description

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)

Primary Outcome Measure Information:

Title

Functional score

Description

Change from baseline functional result (Cumberland Ankle Instability Tool: 0-30 points) at 6 weeks

Time Frame

At baseline and 6 weeks of follow-up

Secondary Outcome Measure Information:

Title

Confidence level

Description

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

Time Frame

At baseline and 6 weeks of follow-up

Title

Ankle instability

Description

Time Frame

At 2 weeks and 6 weeks of follow-up

Title

Ankle pain

Description

Time Frame

At 2 weeks and 6 weeks of follow-up

Title

Safety (adverse events)

Description

Rate of adverse events occurred during the study

Time Frame

6 weeks of follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean HEE

Phone

XX XX XX XX XX

jean.hee@btwin.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Valérie WIECZOREK

Organizational Affiliation

Centre Hospitalier Universitaire de Lille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre de rééducation et de balnéothérapie Kinés Faches

City

Faches-Thumesnil

ZIP/Postal Code

59155

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Centre Hospitalier Universitaire de Lille

City

Lille

ZIP/Postal Code

59000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Valérie WIECZOREK

First Name & Middle Initial & Last Name & Degree

Valérie WIECZOREK

Facility Name

Cabinet de kinésithérapie du Belvédère

City

Paris

ZIP/Postal Code

75019

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charlotte QUATRHOMME

First Name & Middle Initial & Last Name & Degree

Charlotte QUATRHOMME

Facility Name

KOSS Paris 8

City

Paris

Country

France

Individual Site Status

Terminated

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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