HealthyACCELERIXNCT01522690
Assessment of Accelerometric Measurement Devices for Gait Analysis
A study testing Different walk tests with an accelerometer device in people with Healthy, run by Institut de Myologie, France at 1 site in France.
Trial summary
The objective of this study is to obtain normative accelerometry data during the six minute walk test and a 30 second walk test on healthy subjects in order to determine the accelerometric variables that are the most relevant to describe gait disorders in patient populations. Read more about this study
- Who is it for?
- Ages 5 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Different walk tests with an accelerometer device
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Dec 2015
- 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 5 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy ambulant subject
- subject affiliated to a social security system
- subject who signed an informed consent
Who cannot join
- surgery or recent trauma to the lower limbs (under 6 months)
- high performance sport
- chronic treatment alters the strength in the month before inclusion
- pregnant or nursing woman
- person under guardianship or curatorship
- orthopedic, neuromuscular or neurological disease having an impact on the quality of walking
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to obtain normative accelerometry data during the six minute walk test and a 30 second walk test on healthy subjects in order to determine the accelerometric variables that are the most relevant to describe gait disorders in patient populations. Secondary objectives of this study are to investigate the impact of walking speed and muscle strength on the accelerometric parameters, to assess the reproducibility of the method and to compare accelerometric data obtained with two different devices.
- Conditions
- Healthy
- Being tested
- Different walk tests with an accelerometer device
- Keywords
- Accelerometer, gait analysis, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different walk tests with an accelerometer deviceOther
Subjects will performed three walk tests of 50 meter at different speeds, a six minute walk test, a walking test of 30 seconds then a test to measure the maximum force of extension and knee flexion on each leg. The walk tests will be performed with the accelerometer device (Locometrix) worn in a belt
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometric variables measured for each walk test
Measured: At baseline
Accelerometric variables measured for each walk test
Measured: 1 hour after baseline
Secondary outcomes (3)
Gait speed measured for each walk test
Measured: At baseline
Knee flexion and extension strength
Measured: At baseline
Gait speed measured for each walk test
Measured: 1 hour after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Myologie, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522690
- Sponsor's protocol ID
- ACCELERIX
- Acronym
- ACCELERIX
- Status last verified
- Apr 2016
- First submitted
- 4 Jan 2012
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Accelerometric Measurement Devices for Gait Analysis
- ClinicalTrials.gov ID
- NCT01522690
- Acronym / sponsor ID
- ACCELERIX / ACCELERIX
- Conditions
- Healthy
- Keywords
- Accelerometer, gait analysis, Healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institut de Myologie, FranceUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Feb 2012 (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 objective of this study is to obtain normative accelerometry data during the six minute walk test and a 30 second walk test on healthy subjects in order to determine the accelerometric variables that are the most relevant to describe gait disorders in patient populations. Secondary objectives of this study are to investigate the impact of walking speed and muscle strength on the accelerometric parameters, to assess the reproducibility of the method and to compare accelerometric data obtained with two different devices.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- healthy ambulant subject
- subject affiliated to a social security system
- subject who signed an informed consent
Key exclusion criteria (6 listed)
- surgery or recent trauma to the lower limbs (under 6 months)
- high performance sport
- chronic treatment alters the strength in the month before inclusion
- pregnant or nursing woman
- person under guardianship or curatorship
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 |
|---|---|---|
| Different walk tests with an accelerometer deviceSubjects will performed three walk tests of 50 meter at different speeds, a six minute walk test, a walking test of 30 seconds then a test to measure the maximum force of extension and knee flexion on each leg. The walk tests will be performed with the accelerometer device (Locometrix) worn in a belt | Other | – |
Primary outcome
Accelerometric variables measured for each walk test
Time frame: At baseline
Accelerometric variables measured for each walk test
Time frame: 1 hour after baseline
3 secondary outcomes
Gait speed measured for each walk test
Time frame: At baseline
Knee flexion and extension strength
Time frame: At baseline
Gait speed measured for each walk test
Time frame: 1 hour after baseline
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 15 Apr 2016.
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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 Different walk tests with an accelerometer device in people with Healthy, run by Institut de Myologie, France 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 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 15 Apr 2016. 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?
Accelerometric variables measured for each walk test (time frame: At baseline). The study lists 2 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 15 Apr 2016.