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

Not Applicable
Completed
Conditions
Healthy Volunteers
Interventions
Device: proprioceptive knee braces
Device: No knee brace
Registration Number
NCT05716165
Lead Sponsor
Thuasne
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
43
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
self-comparisonproprioceptive knee bracesVolunteers 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.
self-comparisonNo knee braceVolunteers 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.
Primary Outcome Measures
NameTimeMethod
Evaluate the effect of bilateral proprioceptive knee braces on the endurance of subjects compared to without knee brace.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 Outcome Measures
NameTimeMethod
Evaluate the impact of knee braces on balance compared to without knee brace.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.

Evaluate the impact of knee braces on lower limb strength compared to without knee brace.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.

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

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 trainingweek 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

Evaluate the influence of the functional capacity of the knees of each volunteer at inclusion on the various performance parameters measuredDay 0

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

Evaluate the satisfaction of the volunteers with the deviceLast visit

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

Evaluate the tolerance of the knee bracesweek 1, week 2

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

Trial Locations

Locations (1)

Saint-Etienne Jean Monnet University

🇫🇷

Saint-Etienne, France

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