Effect of Proprioceptive Knee Braces on the Performance and Endurance of Recreational Soccer Players Aged 60-80 Years (FOOTEX60-80)

THUASNE

Status: Completed

Conditions: Healthy Volunteers

Treatments: Device: No knee brace; Device: proprioceptive knee braces

Study type: Interventional

Funder types: Industry

Identifiers

NCT05716165

2022-A02522-41

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

43 participants in 1 patient group

self-comparison

Experimental group

Description:

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.

Treatment:

Device: proprioceptive knee braces

Device: No knee brace