NCT02885493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

4.5 years

First QC Date

August 26, 2016

Last Update Submit

September 17, 2019

Conditions

the Elderly

Keywords

Parkinson march

Outcome Measures

Primary Outcomes (1)

  • falls risks

    Assess Falls development risk in the presence of parkinsonian walking

    number of falls during follow-up of 24 months

Secondary Outcomes (3)

  • number of confusional states

    follow-up of 24 months

  • number of hospitalizations

    follow-up of 24 months

  • mortality

    follow-up of 24 months

Study Arms (2)

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

Interventions

testsBEHAVIORAL
Falls is <or = 1 yearfalls is> 1 year

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the eldery

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (2)

  • Kiesmann M, Martin RE, Sauleau E, Bulubas I, Fleury MC, Perisse J, Kaltenbach G, Schmitt E. Diagnosis of vascular parkinsonism: A new tool for gait hypokinesia occurring in older persons. Parkinsonism Relat Disord. 2023 Apr;109:105360. doi: 10.1016/j.parkreldis.2023.105360. Epub 2023 Mar 8.

    PMID: 36921515DERIVED

  • Kiesmann M, Sauleau E, Ewald Martin R, Danan J, Sauer A, Konrad S, Blanc F, Vogel T, Kaltenbach G, Schmitt E. Older Persons Displaying Parkinsonian Gait: Prediction and Explanation of the Recurrent Falling Phenomenon and Its Related Poor Prognosis. Gerontology. 2022;68(12):1402-1414. doi: 10.1159/000521503. Epub 2022 Feb 11.

    PMID: 35152218DERIVED

Study Officials

  • Michèle KIESMANN, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

August 31, 2016

Study Start

March 20, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 18, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)