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Completed

NCT Number: NCT05716165

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

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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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint-Etienne Jean Monnet University

Saint-Etienne, 42270, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

proprioceptive knee braces

Device

The patient will perform the tests with the knee braces.

No knee brace

Device

The patient will perform the tests without the knee brace.

Primary outcomes

  1. Evaluate the effect of bilateral proprioceptive knee braces on the endurance of subjects compared to without knee brace.

    Time frame: week 1

    The evaluation of the subjects' endurance corresponds to the difference in results obtained during the 6-minutes walk test in the absence and presence of knee braces.

Secondary outcomes

  1. Evaluate the impact of knee braces on balance compared to without knee brace.

    Time frame: week 1

    Balance will be evaluated via 2 tests:

    • An unipodal balance test performed on flat ground, eyes open and eyes closed, and the result of the test compared in the absence and presence of knee braces.
    • A bipodal test to objectively measure balance, performed on a force platform with eyes open and eyes closed, to determine the projection of the subject's centre of pressure for 30 seconds. The results of the test will be compared in the absence and presence of knee pads.
  2. Evaluate the impact of knee braces on lower limb strength compared to without knee brace.

    Time frame: week 1

    The strength of the lower limbs will be evaluated via the 30s chair stand test and the result of the test compared in the absence and presence of knee braces.

  3. Evaluate the impact of knee braces on walking speed compared to without knee brace.

    Time frame: week 1

    Walking speed and agility will be evaluated during the 2.5m up and go test and the test result compared in the absence and presence of knee braces.

  4. Evaluate the impact of knee braces on the volunteer's feelings about the stability of his knees, their range of motion, his confidence when walking and his fear of falling after the tests and after the training

    Time frame: week 1, week 2

    The feeling of the volunteer will be evaluated via a questionnaire on the stability of the knee, the amplitude of movement, the confidence during the walk and the fear of falling felt after the tests and after the training

  5. Evaluate the influence of the functional capacity of the knees of each volunteer at inclusion on the various performance parameters measured

    Time frame: Day 0

    The functional capacity of the knees at inclusion will be assessed via the Lysholm questionnaire

  6. Evaluate the satisfaction of the volunteers with the device

    Time frame: Last visit

    The volunteers' satisfaction with the system will be evaluated via a specific satisfaction questionnaire.

  7. Evaluate the tolerance of the knee braces

    Time frame: week 1, week 2

    Tolerance will be evaluated through the collection of adverse events following the wearing of knee braces

Sponsors and collaborators

Lead sponsor

Thuasne

Industry

Registry information

Acronym: FOOTEX60-80

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2023
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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