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

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.

Study Overview

• Status: Completed
• Conditions: the Elderly
• Intervention / Treatment: Behavioral: tests

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Hopitaux universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

the eldery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
falls risks	Assess Falls development risk in the presence of parkinsonian walking	number of falls during follow-up of 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
number of confusional states	follow-up of 24 months
number of hospitalizations	follow-up of 24 months
mortality	follow-up of 24 months

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Michèle KIESMANN, MD, Hopitaux universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2015
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimate): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Parkinson march
• Other Study ID Numbers: 5955

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No