Clinical trial NCT03573232: Prevalence of Abnormal Postures in Parkinson's Disease
Official title: Prevalence of Abnormal Postures in Parkinson's Disease: an Observational Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Pisa Syndrome
Camptocormia
Antecollis
Striatal deformities
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 794
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_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.

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).

Detailed description: Postural abnormalities represent disabling and painful complications in patients with Parkinson's disease (PD). The first postural trunk deviation in PD was first described by James Parkinson himself and recognized as stooped simian appearance, with flexion of the hips and knees, and rounding of the shoulders. Although the stooped posture is a typical feature, more severe spinal misalignment (and deformities) can affect people with PD. These postural deformities include Pisa syndrome (PS), camptocormia (CP), antecollis (AC), scoliosis (S) and striatal deformities related to hand (striatal hand) and/or toes (striatal toes). The prevalence of these postural deformities is variable because several diagnostic criteria have been used to characterize each deformity. Recently, a consensus of diagnostic criteria has been reached in literature permitting us to better mapping the presence of these deformities in people with PD.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The prevalence of postural deformities
timeFrame: 1 day
Secondary outcomes:
measure: Data of birth
timeFrame: 1 day
measure: Sex
timeFrame: 1 day
measure: Body Mass Index
timeFrame: 1 day
measure: SPECIFIC EVALUATION FOR PATIENTS WITH PARKINSON'S DISEASE • Age at PD onset
timeFrame: 1 day
measure: Disease duration of PD
timeFrame: 1 day
measure: Modified Hoehn and Yahr (H&Y);
timeFrame: 1 day
measure: Unified Parkinson's Disease Rating Scale (UPDRS);
timeFrame: 1 day
measure: PD phenotype
timeFrame: 1 day
measure: Laterality of motor symptoms at PD onset
timeFrame: 1 day
measure: Clinical asymmetry
timeFrame: 1 day
measure: Quality of life by means of Parkinson's Disease Questionnaire-8;
timeFrame: 1 day
measure: Latency between PD onset and start of antiparkinsonian therapy
timeFrame: 1 day
measure: Pharmacologic treatment at disease onset of PD
timeFrame: 1 day
measure: Ongoing pharmacological therapy
timeFrame: 1 day
measure: Levodopa equivalent daily dose
timeFrame: 1 day
measure: Number of falls and direction
timeFrame: 1 day
measure: Comorbilities
timeFrame: 1 day
measure: Associated medical conditions
timeFrame: 1 day
measure: Visual Analogue Scale (VAS)
timeFrame: 1 day
measure: SPECIFIC EVALUATION FOR PATIENTS WITH ABNORMAL POSTURES Type of deformity
timeFrame: 1 day
measure: Degrees
timeFrame: 1 day
measure: Latency to develop one or more postural deformity after PD onset
timeFrame: 1 day
measure: Postural deformity duration
timeFrame: 1 day
measure: The pattern of postural deformity onset
timeFrame: 1 day
measure: Postural deformity after drug modification
timeFrame: 1 day
measure: Postural deformity awareness
timeFrame: 1 day
measure: Head compensation
timeFrame: 1 day
measure: Neck head on trunk angle
timeFrame: 1 day
measure: Neck tilt angle
timeFrame: 1 day
measure: Head tilt angle
timeFrame: 1 day
measure: Gaze angle (in case of AC)
timeFrame: 1 day
measure: Ankle and hip flexion (in case of CP)
timeFrame: 1 day
measure: Sensory trick
timeFrame: 1 day
measure: Postural deformity direction only for PS
timeFrame: 1 day
measure: The presence of metronome sign (in case of PS)
timeFrame: 1 day
measure: Side of PD symptoms at onset and PS inclination
timeFrame: 1 day
measure: Side of PD symptoms at onset and hands/feet deformities
timeFrame: 1 day
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Department of Experimental and Clinical Medicine - University "Politecnica delle Marche" Ancona -Italy. Neurorehabilitation Clinic - Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona.
city: Pescara
country: Italy
facility: Department of Neuroscience, Imaging and Clinical Sciences, University G.d'Annunzio of Chieti-Pescara
city: Pisa
country: Italy
facility: Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
city: Roma
country: Italy
facility: IRCCS San Raffaele CTC Centro Parkinson Via della Pisana 235, 00163 Roma
city: Torino
country: Italy
facility: Dipartimento di Neuroscienze A.O. Città della Salute e della Scienza di Torino
city: Trieste
country: Italy
facility: Clinica Neurologica, Dipartimento di Scienze Neurologiche, Chirurgiche e della Salute, Azienda Ospedaliera Universitaria integrata, Universita' di Trieste
city: Verona
country: Italy
facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona
Study officials:
affiliation: Universita di Verona
name: Michele Tinazzi, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Verona
name: Nicola Smania, MD, Professor
role: STUDY_CHAIR
affiliation: Universita di Verona
name: Marialuisa Gandolfi, MD, PhD
role: STUDY_CHAIR
affiliation: Universita di Verona
name: Christian Geroin, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.