Healthy VolunteersFOOTEX60-80NCT05716165
Effect of Proprioceptive Knee Braces on the Performance and Endurance of Recreational Soccer Players Aged 60-80 Years
A study testing proprioceptive knee braces and No knee brace in people with Healthy Volunteers, run by Thuasne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- proprioceptive knee braces and No knee brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2023to 12 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- proprioceptive knee braces, No knee brace
- Keywords
- knee brace, soccer, aged, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proprioceptive knee bracesDevice
The patient will perform the tests with the knee braces.
No knee braceDevice
The patient will perform the tests without the knee brace.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: proprioceptive knee braces; Device: No knee brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 1
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: week 1, week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start14 Feb 2023
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger OULLION, MD, Principal investigator, Saint-Etienne Jean Monnet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716165
- Sponsor's protocol ID
- 2022-A02522-41
- Acronym
- FOOTEX60-80
- Status last verified
- Feb 2025
- First submitted
- 25 Jan 2023
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21468615Bean 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.
PubMed 15221722Buchner 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.
PubMed 9224433Osoba 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.
PubMed 30828632
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proprioceptive Knee Braces on the Performance and Endurance of Recreational Soccer Players Aged 60-80 Years
- ClinicalTrials.gov ID
- NCT05716165
- Acronym / sponsor ID
- FOOTEX60-80 / 2022-A02522-41
- Conditions
- Healthy Volunteers
- Keywords
- knee brace, soccer, aged, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| self-comparison | Experimental | Device: proprioceptive knee braces, Device: No knee braceVolunteers 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proprioceptive knee bracesThe patient will perform the tests with the knee braces. | Device | self-comparison |
| No knee braceThe patient will perform the tests without the knee brace. | Device | self-comparison |
Primary outcome
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.
7 secondary outcomes
Evaluate the impact of knee braces on balance compared to without knee brace.
Time frame: week 1
Evaluate the impact of knee braces on lower limb strength compared to without knee brace.
Time frame: week 1
Evaluate the impact of knee braces on walking speed compared to without knee brace.
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
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
Time frame: Day 0
Evaluate the satisfaction of the volunteers with the device
Time frame: Last visit
Evaluate the tolerance of the knee braces
Time frame: week 1, week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Background: PubMed 21468615Baltaci 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.
- Background: PubMed 15221722Bean 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.
- Background: PubMed 9224433Buchner 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.
- Background: PubMed 30828632Osoba 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.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger OULLION, MD principal investigator
Saint-Etienne Jean Monnet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proprioceptive knee braces and No knee brace in people with Healthy Volunteers, run by Thuasne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of bilateral proprioceptive knee braces on the endurance of subjects compared to without knee brace. (time frame: week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05716165, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.