Gait Disorders, NeurologicNCT03399591
Gait Disorders in Patients With Cognitive Decline
An observational study of Gait Disorders, Neurologic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The prevalence of neurodegenerative diseases will increase over the next decades driven by ageing population. It seems important to develop reliable, replicable and accessible diagnostic tools. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Gait Disorders, Neurologic
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2017to Mar 2019
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patient over the age of 50 with a gait disorder
Who may be able to join
- Patient over 50
- Hospitalized patient in day hospital
- Patient with an etiological diagnosis of his cognitive disorder
- Patient having a neuropsychological assessment
- Patient able to walk without technical help
- Patient having agreed to participate in the study
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Gériatrie Hôpital de la Robertsau
Strasbourg, 67000
Jérémie PERISSE, MD, 33 3 88 11 55 11, jeremie.perisse@chru-strasbourg.fr
Candice Muller, MD, 33 3 88 11 55 11, candice.muller@chru-strasbourg.fr
About this study
Official title: Correlation Between Gait Disorders and Neuropsychological Profile in Patients With Alzheimer's Disease and Lewy Body Disease
The prevalence of neurodegenerative diseases will increase over the next decades driven by ageing population. It seems important to develop reliable, replicable and accessible diagnostic tools.
This is a prospective study whose objective is to study the spatio-temporal parameters of gait in patients with Alzheimer's and Lewy body diseases. 64 patients were included in this study. A comparison of the two pathologies was conducted, followed by an analysis based on four groups (mild, severe Alzheimer's disease, mild, severe Lewy body disease) and a study of the severity of the diseases. To study these parameters, we used the Gaitrite treadmill.
Read more
The analysis of spatio-temporal parameters of walking in Alzheimer's disease and Lewy body disease enables to identify discriminating variables between the two pathologies. The probability of suffering from an Alzheimer's disease decreases with the pace increase but increases with variations in length of the step, and with the rotation of the foot. While the probability of suffering from Lewy body disease increases with the pace, variations in the step duration, and the duration of double support.
These results are interesting but do not allow to establish a diagnostic score for these two diseases. The monitoring of the variations of these parameters at individual level would probably be more relevant and would enable to detect dual pathologies.
- Conditions
- Gait Disorders, Neurologic
- Keywords
- Gait Disorders, Spatio-temporal parameters of walking, Alzheimer's disease, Lewy body disease
- Medical subject headings
- Gait Disorders, Neurologic, Mobility Limitation, Alzheimer Disease, Lewy Body Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
walking test
Measured: 1 hour after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start2 May 2017
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorders, NeurologicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérémie PERISSE, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399591
- Sponsor's protocol ID
- 6963
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 6 Jul 2018
- 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 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Gait Disorders and Neuropsychological Profile in Patients With Alzheimer's Disease and Lewy Body Disease
- ClinicalTrials.gov ID
- NCT03399591
- Acronym / sponsor ID
- 6963
- Conditions
- Gait Disorders, Neurologic
- Keywords
- Gait Disorders, Spatio-temporal parameters of walking, Alzheimer's disease, Lewy body disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 16 Jan 2018 (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 prevalence of neurodegenerative diseases will increase over the next decades driven by ageing population. It seems important to develop reliable, replicable and accessible diagnostic tools.
This is a prospective study whose objective is to study the spatio-temporal parameters of gait in patients with Alzheimer's and Lewy body diseases. 64 patients were included in this study. A comparison of the two pathologies was conducted, followed by an analysis based on four groups (mild, severe Alzheimer's disease, mild, severe Lewy body disease) and a study of the severity of the diseases. To study these parameters, we used the Gaitrite treadmill.
The analysis of spatio-temporal parameters of walking in Alzheimer's disease and Lewy body disease enables to identify discriminating variables between the two pathologies. The probability of suffering from an Alzheimer's disease decreases with the pace increase but increases with variations in length of the step, and with the rotation of the foot. While the probability of suffering from Lewy body disease increases with the pace, variations in the step duration, and the duration of double support.
These results are interesting but do not allow to establish a diagnostic score for these two diseases. The monitoring of the variations of these parameters at individual level would probably be more relevant and would enable to detect dual pathologies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient over the age of 50 with a gait disorder
Key inclusion criteria (6 listed)
- Patient over 50
- Hospitalized patient in day hospital
- Patient with an etiological diagnosis of his cognitive disorder
- Patient having a neuropsychological assessment
- Patient able to walk without technical help
Key exclusion criteria (1 listed)
- Refusal to participate in the study
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
walking test
Time frame: 1 hour after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- 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.
Jérémie PERISSE, MD principal investigator
University Hospital, Strasbourg, France
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 Gait Disorders, Neurologic, run by University Hospital, Strasbourg, 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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jérémie PERISSE, MD (33 3 88 11 55 11, jeremie.perisse@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
walking test (time frame: 1 hour after inclusion). 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 6 Jul 2018.