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Evaluation of Dysfunction of the Basal Ganglia Before a Parkinsonian Walking in the Elderly: Risk of Falling and Confusional State (EVAMARAGEX)

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ClinicalTrials.gov Identifier: NCT02885493
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief 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. 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.

Condition or disease Intervention/treatment
the Elderly Behavioral: tests

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Elderly 's Parkinsonian March : Risk Estimation Multiple Drops From an Evaluation Grid Covering the March, Executive Functions, Vision and Anxiety.
Study Start Date : March 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Falls

Group/Cohort Intervention/treatment
Falls is <or = 1 year
Patients whose number of falls is <or = 1 year
Behavioral: tests
falls is> 1 year
Patients whose numbers falls is> 1 year
Behavioral: tests



Primary Outcome Measures :
  1. falls risks [ Time Frame: number of falls during follow-up of 24 months ]
    Assess Falls development risk in the presence of parkinsonian walking


Secondary Outcome Measures :
  1. number of confusional states [ Time Frame: follow-up of 24 months ]
  2. number of hospitalizations [ Time Frame: follow-up of 24 months ]
  3. mortality [ Time Frame: follow-up of 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
the eldery
Criteria

Inclusion Criteria:

  • 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,
  • Trample,
  • piece U-turn,
  • kyphotic Attitude,
  • Tolerance screw physiotherapy screws

Exclusion Criteria:

  • 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,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885493


Contacts
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Contact: Michèle KIESMANN, MD 03.88.11.55.52 Michele.Kiesmann@chru-strasbourg.fr
Contact: Jeremy PERISSE, MD jeremie.perisse@chru-strasbourg.fr

Locations
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France
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Michèle KIESMANN, MD    03.88.11.55.52    Michele.Kiesmann@chru-strasbourg.fr   
Principal Investigator: Michèle KIESMANN, MD         
Sub-Investigator: Jeremy PERISSE, MD         
Sub-Investigator: Georges KALTENBACH, MD         
Sub-Investigator: Thomas VOGEL, MD         
Sub-Investigator: Delphine GALLO IMPERIALE, MD         
Sub-Investigator: Arnaud SAUER, MD         
Sub-Investigator: Marie-Céline FLEURY, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Michèle KIESMANN, MD Hôpitaux Universitaires de Strasbourg

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02885493     History of Changes
Other Study ID Numbers: 5955
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Strasbourg, France:
Parkinson march