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Clinical Trials/NCT05716165
NCT05716165
Completed
Not Applicable

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

Thuasne1 site in 1 country43 target enrollmentFebruary 14, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Volunteers
Sponsor
Thuasne
Enrollment
43
Locations
1
Primary Endpoint
Evaluate the effect of bilateral proprioceptive knee braces on the endurance of subjects compared to without knee brace.
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 14, 2023
End Date
April 12, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Thuasne
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Evaluate the impact of knee braces on balance compared to without knee brace.(week 1)
  • Evaluate the impact of knee braces on lower limb strength compared to without knee brace.(week 1)
  • Evaluate the impact of knee braces on walking speed compared to without knee brace.(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(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(Day 0)
  • Evaluate the satisfaction of the volunteers with the device(Last visit)
  • Evaluate the tolerance of the knee braces(week 1, week 2)

Study Sites (1)

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