NCT00139321

Brief Summary

Gait disorders and falls are frequent in patients with parkinsonian syndromes. In patients with Parkinson's disease (PD), these signs occurred later during the course of the disease in comparison to patients with other degenerative parkinsonian disorders. The pathophysiology of these symptoms are still not fully understood. Gait initiation challenges the balance control system as the body moves from an upright stable static posture to a continuously unstable gait. The aim of this study is to analyse the gait initiation process in patients with parkinsonian disorders.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

3.1 years

First QC Date

August 30, 2005

Last Update Submit

January 7, 2013

Conditions

Keywords

Gait disordersPostural instabilityparkinsonian syndromeGait initiationParkinson's diseaseAdults

Outcome Measures

Primary Outcomes (1)

  • Biomechanical gait initiation parameters

Interventions

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients able to walk without assistance
  • Patients with Parkinson's disease or other degenerative parkinsonian syndromes (progressive supranuclear palsy \[PSP\], multiple system atrophy \[MSA\], corticobasal degeneration \[CBD\], etc.)

You may not qualify if:

  • Other parkinsonian syndromes
  • Dementia
  • Neuroleptic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere

Paris, 75013, France

Location

MeSH Terms

Conditions

Gait Disorders, NeurologicMobility LimitationParkinsonian DisordersParkinson Disease

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Officials

  • Yves Agid, MD, PhD

    CIC-Pitié-Salpêtrière

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 30, 2005

First Posted

August 31, 2005

Study Start

June 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations