ElderlyBALAGENCT04344223
Effect of Stabilization Shoes on Balance in Elderly
A study testing Balance Shoe and Personal Shoe in people with Elderly, run by University of Burgundy at 1 site in France.
Trial summary
Movement during everyday activities most often requires stable posture. Postural control corresponds to a complex motor ability to maintain / re-establish balance and orient one's body in the environment. Postural stability and equilibrium deteriorate with age. More than 30% of people over 65 years old fall per year. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- Balance Shoe and Personal Shoe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 29 Feb 2020
- 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 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subjects from 65 to 75 years old
- Healthy subjects
- Having given their written informed consent
Who cannot join
- Subject who has fallen during the six months prior to the study.
- Subject who moves with walking aids.
- Subject with severe balance problems or unable to stand up without help
- Subject who takes sedatives or sleeping pills
- Subject with neurological disease (dizziness including turning dizziness, multiple sclerosis, Parkinson's, etc.)
- Subject with history of heart attack
Show all 9Show fewer
- Subject who is short of breath when inactive.
- Subject who has pains limiting walking and standing
- Subject who takes neuroleptics except Anti-depressors if the treatment is long-standing and well-balanced.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Expertise de la Performance - Université de Bourgogne
Dijon, Côte d'Or, 21078
About this study
Official title: Effects of Stabilization Shoes on Balance and Walking. A Cross-over, Controlled, Randomized Single Blind Study.
Movement during everyday activities most often requires stable posture. Postural control corresponds to a complex motor ability to maintain / re-establish balance and orient one's body in the environment. Postural stability and equilibrium deteriorate with age. More than 30% of people over 65 years old fall per year. Falls represent 90% of hip fractures and sometimes result in lasting psychological effects. Shoes are our direct link between the ground and our feet. Wearing shoes plays a major role in postural control. The characteristics of shoes usually worn by elderly people are identified with those of shoes known to be 'dangerous'. In order to improve stability and reduce the risk of falling for the elderly, Axis-Comfort Development® has developed "experimental balance shoes". Their shoes have technical characteristics presented in the scientific literature as beneficial for postural stability.
Therefore, the aim of this study was to investigate the effects of wearing experimental balance shoes on postural balance compared with the people's own shoes. We assumed that postural balance would be improved by experimental balance shoes in an acute way and improved by a familiarization phase.
Read more
This was a controlled, randomized, blind and cross-over study. three sessions were held in our center, each time interspersed with a phase of familiarization at home (7 to 10 days) during which the people had to wear either the experimental balance shoes or their own personal shoes. 21 volunteers in total participated in this study, all between 65 and 75 years old. Five tests were presented randomly for each session and all tests were carried out on a Huber 360 ® (LPG System, France) stabilometric platform. The mains criteria were static equilibrium on one foot and two feet (with eyes open and closed) and secondary criteria were stride frequency during the walk on the spot and stability limits.
An improvement of these multiple criteria during the different sessions would be proof of the positive effect of experimental balance shoes on postural balance in the elderly.
- Conditions
- Elderly
- Being tested
- Balance Shoe, Personal Shoe
- Keywords
- Postural Balance, Accidental Falls, Footwear, Stability, Force platform, Unipedal stance, Bipedal stance, Shoe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance ShoeDevice
Also called Axis Comfort Development® Experimental Balance shoes
Use of experimental balance shoes for carrying out the tests along the three sessions and one of the two familiarization phases
Personal ShoeDevice
Also called Own personal shoes of subjects
Use of Personal shoes (the same for each session) for carrying out the tests along the three sessions and one of the two familiarization phases
| Study group | Role | What they receive |
|---|---|---|
| Experimental balance shoes | Experimental | Tests and familiarization phases with experimental balance shoes (Axis Comfort Development®) Receives: Device: Balance Shoe |
| Personal shoes | Active comparator | Same tasks than the condition "Experimental balance shoes" but realized with personal shoes (own personal shoes of subjects) Receives: Device: Personal Shoe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on a foot with open eyes
Surface of the displacement of the centre of pressure (Value in square millimeters, mm²) during 30 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change of the length of the displacement of the centre of pressure between the three sessions during static balance on a foot with open eyes
Length of the displacement of the centre of pressure (Value in millimeters, mm) during 30 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change of the number of rebalancing gestures between the three sessions during static balance on a foot with open eyes
Number of rebalancing gestures (with the foot or with the hand during test) during 30 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on two feet open eyes
Surface of the displacement of the centre of pressure (Value in square millimeters, mm²) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change of the length of the displacement of the centre of pressure between the three sessions during static balance on two feet open eyes
Length of the displacement of the centre of pressure (Value in millimeters, mm) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change of the average speed of the displacement of the centre of pressure between the three sessions during static balance on two feet open eyes
Average speed of the displacement of the centre of pressure (Value in millimeters per second, mm/s) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change of the number of rebalancing gestures between the three sessions during static balance on two feet open eyes
Number of rebalancing gestures (with the foot or with the hand during test) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Secondary outcomes (17)
Assessing change in walking capacity between the three sessions
Walk at the pace following the change of the Left (on right foot and left leg detached) and Right (opposite) visuals on the platform screen for 50 seconds. Subjects were asked to lift their feet using enough hip flexion to bring the foot halfway up the support leg. The expected number of strides was around 96. Measured on a Huber 360 ® (LPG System, France) force platform (number of strides).
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 0°
Maximal displacement of the centre of pressure at 0°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 45°
Maximal displacement of the centre of pressure at 45°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 90°
Maximal displacement of the centre of pressure at 90°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 135°
Maximal displacement of the centre of pressure at 135°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 180°
Maximal displacement of the centre of pressure at 180°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 225°
Maximal displacement of the centre of pressure at 225°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 270°
Maximal displacement of the centre of pressure at 270°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 315°
Maximal displacement of the centre of pressure at 315°. 8 seconds to go as far as possible (Value in degrees, °). Measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Subjective assessment of the comfort linked to the wearing of the experimental balance shoes
The question was : "How do you feel in general wearing Balance Shoes?" with 4 predefined answers : (1) "Very comfortable" ; (2) "Comfortable" ; (3)"Normal" and (4) "Uncomfortable". Questionary was anonymous
Measured: Measured after wearing experimental balance shoes for a week (familiarization's period)
Subjective assessment of the aesthetics linked to wearing of the experimental balance shoes
The question was : "How do you find the aesthetics of Balance Shoes?" with 4 predefined answers : (1) "To my liking" ; (2) "Correct" ; (3)"Not to my liking" and (4) "No opinion". Questionary was anonymous
Measured: Measured after wearing experimental balance shoes for a week (familiarization's period)
Subjective assessment of the stability linked to wearing of the experimental balance shoes
The question was : "Did you feel more stable wearing Balance Shoes?" with 2 predefined answers : (1) "Yes" ; (2) "No". Questionary was anonymous
Measured: Measured after wearing experimental balance shoes for a week (familiarization's period)
Subjective assessment of the safety linked to wearing of the experimental balance shoes
The question was : "Did you feel safer wearing Balance Shoes?" with 2 predefined answers : (1)"Yes" ; (2) "No". Questionary was anonymous
Measured: Measured after wearing experimental balance shoes for a week (familiarization's period)
Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on two feet closed eyes
Surface of the displacement of the centre of pressure (Value in square millimeters, mm²) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change of the length of the displacement of the centre of pressure between the three sessions during static balance on two feet closed eyes
Length of the displacement of the centre of pressure (Value in millimeters, mm) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change of the average speed of the displacement of the centre of pressure between the three sessions during static balance on two feet open eyes
Average speed of the displacement of the centre of pressure (Value in millimeters per second, mm/s) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change of the number of rebalancing gestures between the three sessions during static balance on two feet open eyes
Number of rebalancing gestures (with the foot or with the hand during test) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Measured: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Jun 2019
- Primary completion15 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Burgundy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Babault, University of Burgundy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344223
- Sponsor's protocol ID
- CEP2001
- Acronym
- BALAGE
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stabilization Shoes on Balance and Walking. A Cross-over, Controlled, Randomized Single Blind Study.
- ClinicalTrials.gov ID
- NCT04344223
- Acronym / sponsor ID
- BALAGE / CEP2001
- Conditions
- Elderly
- Keywords
- Postural Balance, Accidental Falls, Footwear, Stability, Force platform, Unipedal stance, Bipedal stance, Shoe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of BurgundyUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 14 Apr 2020 (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.
Movement during everyday activities most often requires stable posture. Postural control corresponds to a complex motor ability to maintain / re-establish balance and orient one's body in the environment. Postural stability and equilibrium deteriorate with age. More than 30% of people over 65 years old fall per year. Falls represent 90% of hip fractures and sometimes result in lasting psychological effects. Shoes are our direct link between the ground and our feet. Wearing shoes plays a major role in postural control. The characteristics of shoes usually worn by elderly people are identified with those of shoes known to be 'dangerous'. In order to improve stability and reduce the risk of falling for the elderly, Axis-Comfort Development® has developed "experimental balance shoes". Their shoes have technical characteristics presented in the scientific literature as beneficial for postural stability.
Therefore, the aim of this study was to investigate the effects of wearing experimental balance shoes on postural balance compared with the people's own shoes. We assumed that postural balance would be improved by experimental balance shoes in an acute way and improved by a familiarization phase.
This was a controlled, randomized, blind and cross-over study. three sessions were held in our center, each time interspersed with a phase of familiarization at home (7 to 10 days) during which the people had to wear either the experimental balance shoes or their own personal shoes. 21 volunteers in total participated in this study, all between 65 and 75 years old. Five tests were presented randomly for each session and all tests were carried out on a Huber 360 ® (LPG System, France) stabilometric platform. The mains criteria were static equilibrium on one foot and two feet (with eyes open and closed) and secondary criteria were stride frequency during the walk on the spot and stability limits.
An improvement of these multiple criteria during the different sessions would be proof of the positive effect of experimental balance shoes on postural balance in the elderly.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental balance shoes | Experimental | Device: Balance ShoeTests and familiarization phases with experimental balance shoes (Axis Comfort Development®) |
| Personal shoes | Active comparator | Device: Personal ShoeSame tasks than the condition "Experimental balance shoes" but realized with personal shoes (own personal shoes of subjects) |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Subjects from 65 to 75 years old
- Healthy subjects
- Having given their written informed consent
Key exclusion criteria (9 listed)
- Subject who has fallen during the six months prior to the study.
- Subject who moves with walking aids.
- Subject with severe balance problems or unable to stand up without help
- Subject who takes sedatives or sleeping pills
- Subject with neurological disease (dizziness including turning dizziness, multiple sclerosis, Parkinson's, etc.)
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 |
|---|---|---|
| Balance ShoeAlso: Axis Comfort Development® Experimental Balance shoesUse of experimental balance shoes for carrying out the tests along the three sessions and one of the two familiarization phases | Device | Experimental balance shoes |
| Personal ShoeAlso: Own personal shoes of subjectsUse of Personal shoes (the same for each session) for carrying out the tests along the three sessions and one of the two familiarization phases | Device | Personal shoes |
Primary outcome
Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on a foot with open eyes
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Surface of the displacement of the centre of pressure (Value in square millimeters, mm²) during 30 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Assessing change of the length of the displacement of the centre of pressure between the three sessions during static balance on a foot with open eyes
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Length of the displacement of the centre of pressure (Value in millimeters, mm) during 30 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Assessing change of the number of rebalancing gestures between the three sessions during static balance on a foot with open eyes
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Number of rebalancing gestures (with the foot or with the hand during test) during 30 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on two feet open eyes
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Surface of the displacement of the centre of pressure (Value in square millimeters, mm²) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Assessing change of the length of the displacement of the centre of pressure between the three sessions during static balance on two feet open eyes
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Length of the displacement of the centre of pressure (Value in millimeters, mm) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Assessing change of the average speed of the displacement of the centre of pressure between the three sessions during static balance on two feet open eyes
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Average speed of the displacement of the centre of pressure (Value in millimeters per second, mm/s) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Assessing change of the number of rebalancing gestures between the three sessions during static balance on two feet open eyes
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Number of rebalancing gestures (with the foot or with the hand during test) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
17 secondary outcomes
Assessing change in walking capacity between the three sessions
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 0°
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 45°
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 90°
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 135°
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 180°
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 225°
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 270°
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change in stability limits between the three sessions at 315°
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Subjective assessment of the comfort linked to the wearing of the experimental balance shoes
Time frame: Measured after wearing experimental balance shoes for a week (familiarization's period)
Subjective assessment of the aesthetics linked to wearing of the experimental balance shoes
Time frame: Measured after wearing experimental balance shoes for a week (familiarization's period)
Subjective assessment of the stability linked to wearing of the experimental balance shoes
Time frame: Measured after wearing experimental balance shoes for a week (familiarization's period)
Subjective assessment of the safety linked to wearing of the experimental balance shoes
Time frame: Measured after wearing experimental balance shoes for a week (familiarization's period)
Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on two feet closed eyes
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change of the length of the displacement of the centre of pressure between the three sessions during static balance on two feet closed eyes
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change of the average speed of the displacement of the centre of pressure between the three sessions during static balance on two feet open eyes
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Assessing change of the number of rebalancing gestures between the three sessions during static balance on two feet open eyes
Time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
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 14 Apr 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Shoe and Personal Shoe in people with Elderly, run by University of Burgundy 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 3 inclusion and 9 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 14 Apr 2020. 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?
Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on a foot with open eyes (time frame: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2020.