Multiple SclerosisMARCHENCT02896933
Electrophysiological Study of Spatiotemporal Gait Parameters in Patients in Early Stage of Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
35 patients with multiple sclerosis have been enrolled in a previous study to record and analyze gait parameters. This study aims to enroll gender and and matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jan 2015
- 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 18 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 35 patients with multiple sclerosis progressing for less than 5 years, age 18 to 54 years old, and handicap score (EDSS) < 2 in all the subscores concerning gait, have been enrolled in a previous observational study recording and analyzing gait parameters. This study aims to enroll gender and aed matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'. The 35 patients have given their consent for this new data analysis.
Who may be able to join
- subjects without any gait trouble
- age ≥ 18 and < 55 years old
- gender and age (+/- 5 years) matched
Who cannot join
- pathology with potential gait impairment
- pregnant or breast feeding patient
- patient under legal protection
- no health insurance coverage
- absence of written informed consent
About this study
35 patients with multiple sclerosis have been enrolled in a previous study to record and analyze gait parameters.
This study aims to enroll gender and and matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with multiple sclerosis | recruited in a former study | |
| healthy control subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation coefficient of gait cadence
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Primary completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Raphaël DEPAZ, MD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896933
- Sponsor's protocol ID
- RDZ_2014_17
- Acronym
- MARCHE
- Status last verified
- Sep 2016
- First submitted
- 7 Sep 2016
- Last updated
- 12 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Study of Spatiotemporal Gait Parameters in Patients in Early Stage of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02896933
- Acronym / sponsor ID
- MARCHE / RDZ_2014_17
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Primary completion
- Jan 2015 (actual)
- First posted
- 12 Sep 2016 (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.
35 patients with multiple sclerosis have been enrolled in a previous study to record and analyze gait parameters.
This study aims to enroll gender and and matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with multiple sclerosis | – | –recruited in a former study |
| healthy control subjects | – | – |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 35 patients with multiple sclerosis progressing for less than 5 years, age 18 to 54 years old, and handicap score (EDSS) < 2 in all the subscores concerning gait, have been enrolled in a previous observational study recording and analyzing gait parameters. This study aims to enroll gender and aed matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'. The 35 patients have given their consent for this new data analysis.
Key inclusion criteria (3 listed)
- subjects without any gait trouble
- age ≥ 18 and < 55 years old
- gender and age (+/- 5 years) matched
Key exclusion criteria (5 listed)
- pathology with potential gait impairment
- pregnant or breast feeding patient
- patient under legal protection
- no health insurance coverage
- absence of written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variation coefficient of gait cadence
Time frame: 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 12 Sep 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.
Raphaël DEPAZ, MD principal investigator
Fondation OPH A de Rothschild
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 5 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 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Variation coefficient of gait cadence (time frame: baseline). 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 12 Sep 2016.