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

Healthy Volunteers Clinical Trial

— FOOTEX60-80  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716165
• Other study ID #: 2022-A02522-41
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: May 2023

Study information

• Verified date: April 2023
• Source: Thuasne
• Contact: Roger OULLION, MD
• Phone: (0)477281047
• Email: rogeroullion[@]sfr.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• proprioceptive knee braces
The patient will perform the tests with the knee braces.
• No knee brace
The patient will perform the tests without the knee brace.

Locations

Country	Name	City	State
France	Saint-Etienne Jean Monnet University	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Thuasne

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the impact of knee braces on balance compared to without knee brace.	Balance will be evaluated via a 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.	week 1
Secondary	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.	week 1
Secondary	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.	week 1
Secondary	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	week 1, week 2
Secondary	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	Day 0
Secondary	Evaluate the satisfaction of the volunteers with the device	The volunteers' satisfaction with the system will be evaluated via a specific satisfaction questionnaire.	Last visit
Secondary	Evaluate the tolerance of the knee braces	Tolerance will be evaluated through the collection of adverse events following the wearing of knee braces	week 1, week 2