An interventional study of proprioceptive knee braces and No knee brace in Healthy Volunteers, sponsored by Thuasne. Completed at 1 site in France. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Thuasne · Not applicable, Interventional, and Other
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.
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.
Thuasne is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: proprioceptive knee braces · Device: No knee brace
The patient will perform the tests with the knee braces.
The patient will perform the tests without the knee brace.
Evaluate the effect of bilateral proprioceptive knee braces on the endurance of subjects compared to without knee brace.
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.
Time frame: week 1
Evaluate the impact of knee braces on balance compared to without knee brace.
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.
Time frame: week 1
Evaluate the impact of knee braces on lower limb strength compared to without knee brace.
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.
Time frame: week 1
Evaluate the impact of knee braces on walking speed compared to without knee brace.
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.
Time frame: week 1
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
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
Time frame: week 1, week 2
Evaluate the influence of the functional capacity of the knees of each volunteer at inclusion on the various performance parameters measured
The functional capacity of the knees at inclusion will be assessed via the Lysholm questionnaire
Time frame: Day 0
Evaluate the satisfaction of the volunteers with the device
The volunteers' satisfaction with the system will be evaluated via a specific satisfaction questionnaire.
Time frame: Last visit
Evaluate the tolerance of the knee braces
Tolerance will be evaluated through the collection of adverse events following the wearing of knee braces
Time frame: week 1, week 2
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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