NCT03573232

Brief Summary

Postural abnormalities represent disabling and painful complications in patients with Parkinson's disease (PD). The stooped posture is a typical feature of PD but with advancing of disease more severe body abnormalities can affect people with PD. These deformities include Pisa syndrome, camptocormia, antecollis, scoliosis and striatal deformities related to hand (striatal hand) and/or toes (striatal toes).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
794

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
unknown

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 7, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

7 months

First QC Date

May 7, 2018

Last Update Submit

July 14, 2018

Conditions

Keywords

Parkinson DiseasePisa SyndromeCamptocormiaAntecollisStriatal deformities

Outcome Measures

Primary Outcomes (1)

  • The prevalence of postural deformities

    % of people with Parkinson's disease reporting Pisa syndrome, camptocormia, antecollis, scoliosis and striatal deformities related to hand (striatal hand) and toes (striatal toes).

    1 day

Secondary Outcomes (37)

  • Data of birth

    1 day

  • Sex

    1 day

  • Body Mass Index

    1 day

  • SPECIFIC EVALUATION FOR PATIENTS WITH PARKINSON'S DISEASE • Age at PD onset

    1 day

  • Disease duration of PD

    1 day

  • +32 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In the present multicenter study, consecutive outpatients with PD attending 7 movement disorders Italian tertiary centers (Verona, Ancona, Chieti, Pisa, Torino, Trieste, Roma) will be invited to participate. Participants will be considered enrolled after signing the consent form.

You may qualify if:

  • Participants will be considered enrolled after signing the consent form;
  • Diagnosis of Parkinson's disease;

You may not qualify if:

  • Concomitant neurologic diseases known to negatively affect posture;
  • A history of major spinal surgery or muscle and/or skeletal diseases;
  • Treatment with drugs potentially able to induce abnormal postures;
  • Clinical features consistent with a diagnosis of atypical parkinsonism;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Department of Experimental and Clinical Medicine - University "Politecnica delle Marche" Ancona -Italy. Neurorehabilitation Clinic - Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona.

Ancona, Italy

RECRUITING

Department of Neuroscience, Imaging and Clinical Sciences, University G.d'Annunzio of Chieti-Pescara

Pescara, Italy

RECRUITING

Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy

Pisa, Italy

RECRUITING

IRCCS San Raffaele CTC Centro Parkinson Via della Pisana 235, 00163 Roma

Roma, Italy

RECRUITING

Dipartimento di Neuroscienze A.O. Città della Salute e della Scienza di Torino

Torino, Italy

RECRUITING

Clinica Neurologica, Dipartimento di Scienze Neurologiche, Chirurgiche e della Salute, Azienda Ospedaliera Universitaria integrata, Universita' di Trieste

Trieste, Italy

RECRUITING

Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona

Verona, 37134, Italy

RECRUITING

Related Publications (4)

  • Doherty KM, van de Warrenburg BP, Peralta MC, Silveira-Moriyama L, Azulay JP, Gershanik OS, Bloem BR. Postural deformities in Parkinson's disease. Lancet Neurol. 2011 Jun;10(6):538-49. doi: 10.1016/S1474-4422(11)70067-9. Epub 2011 Apr 22.

    PMID: 21514890BACKGROUND
  • Tinazzi M, Geroin C, Gandolfi M, Smania N, Tamburin S, Morgante F, Fasano A. Pisa syndrome in Parkinson's disease: An integrated approach from pathophysiology to management. Mov Disord. 2016 Dec;31(12):1785-1795. doi: 10.1002/mds.26829. Epub 2016 Oct 25.

    PMID: 27779784BACKGROUND
  • Srivanitchapoom P, Hallett M. Camptocormia in Parkinson's disease: definition, epidemiology, pathogenesis and treatment modalities. J Neurol Neurosurg Psychiatry. 2016 Jan;87(1):75-85. doi: 10.1136/jnnp-2014-310049. Epub 2015 Apr 20.

    PMID: 25896683BACKGROUND
  • Pandey S, Garg H. Postural & striatal deformities in Parkinson;s disease: Are these rare? Indian J Med Res. 2016 Jan;143(1):11-7. doi: 10.4103/0971-5916.178577.

    PMID: 26997007BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseCamptocormia

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Michele Tinazzi, MD, PhD, Professor

    Universita di Verona

    PRINCIPAL INVESTIGATOR
  • Nicola Smania, MD, Professor

    Universita di Verona

    STUDY CHAIR
  • Marialuisa Gandolfi, MD, PhD

    Universita di Verona

    STUDY CHAIR
  • Christian Geroin, PhD

    Universita di Verona

    STUDY CHAIR

Central Study Contacts

Michele Tinazzi, MD, PhD, Professor

CONTACT

Christian Geroin, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D. Full Professor

Study Record Dates

First Submitted

May 7, 2018

First Posted

June 29, 2018

Study Start

March 7, 2018

Primary Completion

October 7, 2018

Study Completion

October 7, 2018

Last Updated

July 17, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations