Clinical trial NCT02885493: Evaluation of Dysfunction of the Basal Ganglia Before a Parkinsonian Walking in the Elderly: Risk of Falling and Confusional State
Official title: The Elderly 's Parkinsonian March : Risk Estimation Multiple Drops From an Evaluation Grid Covering the March, Executive Functions, Vision and Anxiety.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: the Elderly
Keywords: Parkinson march
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the eldery

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.


Eligibility 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

Primary outcomes:
measure: falls risks
timeFrame: number of falls during follow-up of 24 months
Secondary outcomes:
measure: number of confusional states
timeFrame: follow-up of 24 months
measure: number of hospitalizations
timeFrame: follow-up of 24 months
measure: mortality
timeFrame: follow-up of 24 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Michèle KIESMANN, MD
role: PRINCIPAL_INVESTIGATOR
References: