Elderly PeopleNCT02547285
Analysis of the Biomechanics of Walking
An observational study of Elderly People and Falls, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The proportion of people aged 60 and over in the French population has increased from 18% in 1970 to over 22% in 2010. One major problem in the elderly is falling. About half of these falls cause a minor injury and between 5% and 25% will cause a more serious injury such as a fracture or a sprain (Alexander et al.… Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly People, Falls
- What is being tested?
- Shoes characteristics
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Jan 2014
- Phase
- Observational
- 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 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elderly people
Who may be able to join
- Topic of footwear for women 37-38-39 and 41-42-43 for men
Who cannot join
- Presence major pathology, fracture or surgery, at the musculoskeletal system, under 3 years
- Presence of prosthesis in the lower limb (hip, knee, ankle)
- Presence of hallux valgus or pronounced toe claw,
- Diabetes,
- Presence of osteoarthritis in the lower limbs
- Presence of medication or other problems affecting the balance of subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Biomechanics of Walking in the Senior Under the Terms of Footwear
The proportion of people aged 60 and over in the French population has increased from 18% in 1970 to over 22% in 2010.
One major problem in the elderly is falling. About half of these falls cause a minor injury and between 5% and 25% will cause a more serious injury such as a fracture or a sprain (Alexander et al., 1992; Nevitt et al., 1991).
Read more
It therefore seems essential to study the locomotion of seniors to limit the maximum risk of falling into a public health measure.
Two factors may be involved:
- The first corresponds to factors related to natural aging topics
- The second is the environment that is a real problem for seniors (Rolling showers, presence of works ....) And especially the port of inappropriate footwear.
Indeed, most of the elderly, institutionalized or not, do not wear proper shoes. It is this parameter that will be highlighted in our study.
Read the detailed description
The subjects will test different characteristics on the same shoe. A single parameter vary for each condition (Different insole, heel height, stem length ...) For each condition, analysis of locomotion on treadmill ADAL be performed as well as tests on postural balance platform. Kinematic measurements, accelerometer and postural will be performed for each subject.
- Conditions
- Elderly People, Falls
- Being tested
- Shoes characteristics
- Keywords
- biomechanics of walking, footwear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoes characteristicsOther
A single parameter of shoe vary for each test (Different insole, heel height, stem length ...)
| Study group | Role | What they receive |
|---|---|---|
| Shoes characteristics in elderly people | The subjects will test different characteristics on the same shoe. A single parameter vary for each test (Different insole, heel height, stem length ...) Receives: Other: Shoes characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best stability shoe
The pair of shoe that will provide the best comfort and driving stability defined by (composite measure) :
- the largest step
- and the small time single support
- and the lowest medial-lateral force to ADAL carpet
- and the smallest ellipse surface
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startFeb 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PeopleStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger OUILLON, MD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547285
- Sponsor's protocol ID
- 1208136
- Other IDs
- 2012-A01193-40
- Status last verified
- Sep 2015
- First submitted
- 9 Sep 2015
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Biomechanics of Walking in the Senior Under the Terms of Footwear
- ClinicalTrials.gov ID
- NCT02547285
- Acronym / sponsor ID
- 1208136
- Conditions
- Elderly People, Falls
- Keywords
- biomechanics of walking, footwear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Sep 2015 (estimated)
- 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 proportion of people aged 60 and over in the French population has increased from 18% in 1970 to over 22% in 2010.
One major problem in the elderly is falling. About half of these falls cause a minor injury and between 5% and 25% will cause a more serious injury such as a fracture or a sprain (Alexander et al., 1992; Nevitt et al., 1991).
It therefore seems essential to study the locomotion of seniors to limit the maximum risk of falling into a public health measure.
Two factors may be involved:
- The first corresponds to factors related to natural aging topics
- The second is the environment that is a real problem for seniors (Rolling showers, presence of works ....) And especially the port of inappropriate footwear.
Indeed, most of the elderly, institutionalized or not, do not wear proper shoes. It is this parameter that will be highlighted in our study.
Detailed description
The subjects will test different characteristics on the same shoe. A single parameter vary for each condition (Different insole, heel height, stem length ...) For each condition, analysis of locomotion on treadmill ADAL be performed as well as tests on postural balance platform. Kinematic measurements, accelerometer and postural will be performed for each subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoes characteristics in elderly people | – | Other: Shoes characteristicsThe subjects will test different characteristics on the same shoe. A single parameter vary for each test (Different insole, heel height, stem length ...) |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly people
Key inclusion criteria (1 listed)
- Topic of footwear for women 37-38-39 and 41-42-43 for men
Key exclusion criteria (6 listed)
- Presence major pathology, fracture or surgery, at the musculoskeletal system, under 3 years
- Presence of prosthesis in the lower limb (hip, knee, ankle)
- Presence of hallux valgus or pronounced toe claw,
- Diabetes,
- Presence of osteoarthritis in the lower limbs
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 |
|---|---|---|
| Shoes characteristicsA single parameter of shoe vary for each test (Different insole, heel height, stem length ...) | Other | Shoes characteristics in elderly people |
Primary outcome
Best stability shoe
Time frame: 1 year
The pair of shoe that will provide the best comfort and driving stability defined by (composite measure) : * the largest step * and the small time single support * and the lowest medial-lateral force to ADAL carpet * and the smallest ellipse surface
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 11 Sep 2015.
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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.
Roger OUILLON, MD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly People and Falls, run by Centre Hospitalier Universitaire de Saint Etienne 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 1 inclusion and 6 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 11 Sep 2015. 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?
Best stability shoe (time frame: 1 year). 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 11 Sep 2015; AzTrials last refreshed its copy on 7 Nov 2026.