Effect of Proprioceptive Knee Braces on the Performance and Endurance of Recreational Soccer Players Aged 60-80 Years

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-14

Study Completion Date

2024-04-12

Brief Summary

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The objective of the study is to evaluate the effect of wearing bilateral proprioceptive knee braces on the endurance of subjects aged 60 to 80 years.

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Detailed Description

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Sporting activity has proven health benefits, particularly for older adults, whose balance and neuromuscular functions decline with age.

On the other hand, physical activity in the elderly population may be hampered by inadequate physical condition, muscle or proprioceptive deficits, or fear of falling or injuring. A proprioceptive knee brace could therefore make physical activity safer and thus improve performance, balance, and ultimately the quality of life of the participants.

The objective of the study is to evaluate the effect of wearing bilateral proprioceptive knee braces on the endurance of subjects aged 60 to 80 years.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a prospective, monocentric, randomized clinical investigation (order of tests with and without knee braces), carried out in open, over a period of 2 weeks (cohort 1) or 12 weeks (cohort 2), in a population of people aged 60 to 80 years practicing recreational soccer.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

the clinical trial is carried out in open label

Study Groups

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self-comparison

Volunteers will be asked to wear a knee brace on each limb during one of the training sessions. At the end of this training session, a questionnaire will be given to the volunteer to evaluate knee stability, range of motion, confidence when walking, and fear of falling.

The volunteers will then have to participate in 2 test sessions: one with and one without knee braces.

The patient will perform tests (Unipodal balance on flat ground, 30s chair stand test, 2,5m up and go test, 6 min-walk) with and without the proprioceptive knee brace in a randomized order.

At the end of the tests with and without knee brace, a questionnaire will be given to the volunteer to evaluate the stability of the knee, the range of motion, the confidence when walking, the fear of falling, as well as a satisfaction questionnaire about the device.

There is also a satisfaction questionnaire regarding the proprioceptive knee brace to be completed at the end of the study.

Group Type EXPERIMENTAL

proprioceptive knee braces

Intervention Type DEVICE

The patient will perform the tests with the knee braces.

No knee brace

Intervention Type DEVICE

The patient will perform the tests without the knee brace.

Interventions

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proprioceptive knee braces

The patient will perform the tests with the knee braces.

Intervention Type DEVICE

No knee brace

The patient will perform the tests without the knee brace.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject practicing recreational soccer
* Subject included in the LIBM (inter-university laboratory of motor biology) study: "Effect of recreational soccer practice in persons aged 60 to 80 years"
* Patient whose knee measurements are compatible with the knee brace sizes
* Patient who has signed a free and informed consent form
* Patient affiliated or entitled to a social security plan

Exclusion Criteria

* Patients with any of the contraindications to the use of the knee brace, as indicated in the instructions for use
* Patient with a major cognitive impairment incompatible with participation in a clinical trial
* Patient participating in another clinical investigation conducted to establish the conformity of a device impacting the judgment criteria
* Vulnerable patient according to article L1121-6 of the public health code, person subject to a legal protection measure or unable to consent freely

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes