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

NCT05716165 | Completed

• 1 other identifier: 2022-A02522-41
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

knee brace; soccer; aged; Exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  week 1

Secondary Outcomes (7)

• 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

Study Arms (1)

self-comparison

EXPERIMENTAL

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

Interventions

proprioceptive knee braces DEVICE

The patient will perform the tests with the knee braces.

self-comparison

No knee brace DEVICE

The patient will perform the tests without the knee brace.

self-comparison

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thuasne: lead

Study Sites (1)

Saint-Etienne Jean Monnet University

Saint-Etienne, 42270, France

Location

Related Publications (4)

• Baltaci G, Aktas G, Camci E, Oksuz S, Yildiz S, Kalaycioglu T. The effect of prophylactic knee bracing on performance: balance, proprioception, coordination, and muscular power. Knee Surg Sports Traumatol Arthrosc. 2011 Oct;19(10):1722-8. doi: 10.1007/s00167-011-1491-3. Epub 2011 Apr 6.

  PMID: 21468615 BACKGROUND

• Bean JF, Vora A, Frontera WR. Benefits of exercise for community-dwelling older adults. Arch Phys Med Rehabil. 2004 Jul;85(7 Suppl 3):S31-42; quiz S43-4. doi: 10.1016/j.apmr.2004.03.010.

  PMID: 15221722 BACKGROUND

• Buchner DM, Cress ME, de Lateur BJ, Esselman PC, Margherita AJ, Price R, Wagner EH. The effect of strength and endurance training on gait, balance, fall risk, and health services use in community-living older adults. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M218-24. doi: 10.1093/gerona/52a.4.m218.

  PMID: 9224433 BACKGROUND

• Osoba MY, Rao AK, Agrawal SK, Lalwani AK. Balance and gait in the elderly: A contemporary review. Laryngoscope Investig Otolaryngol. 2019 Feb 4;4(1):143-153. doi: 10.1002/lio2.252. eCollection 2019 Feb.

  PMID: 30828632 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Roger OULLION, MD

  Saint-Etienne Jean Monnet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: the clinical trial is carried out in open label
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, monocentric, randomized clinical investigation (order of tests with and without knee braces), carried out in open, over a period of 2 weeks (cohort 1) or 12 weeks (cohort 2), in a population of people aged 60 to 80 years practicing recreational soccer.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 8, 2023
• Study Start: February 14, 2023
• Primary Completion: April 12, 2024
• Study Completion: April 12, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

FR (1)