the ElderlyEVAMARAGEXNCT02885493
Evaluation of Dysfunction of the Basal Ganglia Before a Parkinsonian Walking in the Elderly: Risk of Falling and Confusional State
An observational study of the Elderly, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The strong relationship between falling and severity of cognitive impairment in the elderly is well established. The association premorbid gait and executive disorders suggests that they are under tension by the same mechanisms. The gait fortiori neurological are fall risk factors. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- the Elderly
- What is being tested?
- tests
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2015to Sep 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: the eldery
Who may be able to join
- Age: 75 years,
- man or woman,
- Diagnostic Criteria for Parkinson walking: at least 3 of the following symptoms:
- Loss of swinging arms,
- Decrease in stride walking slowly,
- feet as glued to the ground,
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- Trample,
- piece U-turn,
- kyphotic Attitude,
- Tolerance screw physiotherapy screws
Who cannot join
- Unrecovered delirium,
- Unable to walk for a distance of 6 meters in length without technical assistance,
- Traumatic fall phase of rehabilitation,
- Acute pathology,
- Unstabilized psychiatric pathology,
- Symptomatic orthostatic hypotension,
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- Severe depressive syndrome untreated
- Subjects with a sufficient gap to explain the falls:
- cerebellar syndrome,
- a pyramidal syndrome with sequelae pyramidal deficit and cortical stroke
- peripheral pathology,
- rheumatic disease,
- orthopedic pathology,
- Mini Metam State Examination <18,
- Parkinsonism induced by neuroleptics,
- Not cured cancer,
- Psychotropic drugs (benzodiazepines and antipsychotics) with significant sedative effect inducing excessive daytime sleepiness namely psychotropic half long life, and high dose over 2 psychotropic
- Severe heart failure
- Severe respiratory failure,
- Associated diseases and treatments interfering
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Elderly 's Parkinsonian March : Risk Estimation Multiple Drops From an Evaluation Grid Covering the March, Executive Functions, Vision and Anxiety.
The strong relationship between falling and severity of cognitive impairment in the elderly is well established. The association premorbid gait and executive disorders suggests that they are under tension by the same mechanisms. The gait fortiori neurological are fall risk factors. Dysfunctions underlying disorders as Parkinson called march executive disorders are subcortical origin involving so the basal ganglia. This study is indeed based on the assumption that the dysfunction of the basal ganglia as observed in parkinsonian syndromes resulting in disorders of posture and walking, by dysexecutive syndrome, anxiety and the contrast vision disorders. These gait exposed to falls and dysexecutive these disorders with cognitive impairment and greater susceptibility to confusional states. The executive disorders, gait disorders, anxiety, disturbances of vision and especially saccadic eye movements, impaired vision contrasts are well established in the degenerative parkinsonian syndromes. This study proposes a new approach to assessing gait disorders to define a high risk of falling in the presence of parkinsonian walking in the elderly over 75 years.
- Conditions
- the Elderly
- Being tested
- tests
- Keywords
- Parkinson march
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Falls is <or = 1 year | Patients whose number of falls is <or = 1 year Receives: Behavioral: tests | |
| falls is> 1 year | Patients whose numbers falls is> 1 year Receives: Behavioral: tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
falls risks
Assess Falls development risk in the presence of parkinsonian walking
Measured: number of falls during follow-up of 24 months
Secondary outcomes (3)
number of confusional states
Measured: follow-up of 24 months
number of hospitalizations
Measured: follow-up of 24 months
mortality
Measured: follow-up of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start20 Mar 2015
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for the ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michèle KIESMANN, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885493
- Sponsor's protocol ID
- 5955
- Acronym
- EVAMARAGEX
- Status last verified
- Sep 2019
- First submitted
- 26 Aug 2016
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kiesmann M, Martin RE, Sauleau E, Bulubas I, Fleury MC, Perisse J, Kaltenbach G, Schmitt E. Diagnosis of vascular parkinsonism: A new tool for gait hypokinesia occurring in older persons. Parkinsonism Relat Disord. 2023 Apr;109:105360. doi: 10.1016/j.parkreldis.2023.105360. Epub 2023 Mar 8.
PubMed 36921515Kiesmann M, Sauleau E, Ewald Martin R, Danan J, Sauer A, Konrad S, Blanc F, Vogel T, Kaltenbach G, Schmitt E. Older Persons Displaying Parkinsonian Gait: Prediction and Explanation of the Recurrent Falling Phenomenon and Its Related Poor Prognosis. Gerontology. 2022;68(12):1402-1414. doi: 10.1159/000521503. Epub 2022 Feb 11.
PubMed 35152218
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Elderly 's Parkinsonian March : Risk Estimation Multiple Drops From an Evaluation Grid Covering the March, Executive Functions, Vision and Anxiety.
- ClinicalTrials.gov ID
- NCT02885493
- Acronym / sponsor ID
- EVAMARAGEX / 5955
- Conditions
- the Elderly
- Keywords
- Parkinson march
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Mar 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 31 Aug 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.
The strong relationship between falling and severity of cognitive impairment in the elderly is well established. The association premorbid gait and executive disorders suggests that they are under tension by the same mechanisms. The gait fortiori neurological are fall risk factors. Dysfunctions underlying disorders as Parkinson called march executive disorders are subcortical origin involving so the basal ganglia. This study is indeed based on the assumption that the dysfunction of the basal ganglia as observed in parkinsonian syndromes resulting in disorders of posture and walking, by dysexecutive syndrome, anxiety and the contrast vision disorders. These gait exposed to falls and dysexecutive these disorders with cognitive impairment and greater susceptibility to confusional states. The executive disorders, gait disorders, anxiety, disturbances of vision and especially saccadic eye movements, impaired vision contrasts are well established in the degenerative parkinsonian syndromes. This study proposes a new approach to assessing gait disorders to define a high risk of falling in the presence of parkinsonian walking in the elderly over 75 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Falls is <or = 1 year | – | Behavioral: testsPatients whose number of falls is <or = 1 year |
| falls is> 1 year | – | Behavioral: testsPatients whose numbers falls is> 1 year |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- the eldery
Key inclusion criteria (10 listed)
- Age: 75 years,
- man or woman,
- Diagnostic Criteria for Parkinson walking: at least 3 of the following symptoms:
- Loss of swinging arms,
- Decrease in stride walking slowly,
Key exclusion criteria (20 listed)
- Unrecovered delirium,
- Unable to walk for a distance of 6 meters in length without technical assistance,
- Traumatic fall phase of rehabilitation,
- Acute pathology,
- Unstabilized psychiatric pathology,
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 |
|---|---|---|
| tests | Behavioural | Falls is <or = 1 year, falls is> 1 year |
Primary outcome
falls risks
Time frame: number of falls during follow-up of 24 months
Assess Falls development risk in the presence of parkinsonian walking
3 secondary outcomes
number of confusional states
Time frame: follow-up of 24 months
number of hospitalizations
Time frame: follow-up of 24 months
mortality
Time frame: follow-up of 24 months
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 18 Sep 2019.
- Derived from this study: PubMed 36921515Kiesmann M, Martin RE, Sauleau E, Bulubas I, Fleury MC, Perisse J, Kaltenbach G, Schmitt E. Diagnosis of vascular parkinsonism: A new tool for gait hypokinesia occurring in older persons. Parkinsonism Relat Disord. 2023 Apr;109:105360. doi: 10.1016/j.parkreldis.2023.105360. Epub 2023 Mar 8.
- Derived from this study: PubMed 35152218Kiesmann M, Sauleau E, Ewald Martin R, Danan J, Sauer A, Konrad S, Blanc F, Vogel T, Kaltenbach G, Schmitt E. Older Persons Displaying Parkinsonian Gait: Prediction and Explanation of the Recurrent Falling Phenomenon and Its Related Poor Prognosis. Gerontology. 2022;68(12):1402-1414. doi: 10.1159/000521503. Epub 2022 Feb 11.
- 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.
Michèle KIESMANN, MD principal investigator
Hôpitaux Universitaires de Strasbourg
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 the Elderly, 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 10 inclusion and 20 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 18 Sep 2019. 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?
falls risks (time frame: number of falls during follow-up of 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02885493, which also lists 2 linked publications.
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 18 Sep 2019.