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

the Elderly Clinical Trial

— EVAMARAGEX  

Official title:

The Elderly 's Parkinsonian March : Risk Estimation Multiple Drops From an Evaluation Grid Covering the March, Executive Functions, Vision and Anxiety.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885493
• Other study ID #: 5955
• Status: Completed
• Start date: March 20, 2015
• Est. completion date: September 2019

Study information

• Verified date: September 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• the Elderly

Intervention

Behavioral:
• tests

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	falls risks	Assess Falls development risk in the presence of parkinsonian walking	number of falls during follow-up of 24 months
Secondary	number of confusional states		follow-up of 24 months
Secondary	number of hospitalizations		follow-up of 24 months
Secondary	mortality		follow-up of 24 months