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Completed

NCT Number: NCT02885493

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

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.

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Key information

Conditions

the Elderly

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tests

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: EVAMARAGEX

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2016
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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