Prevalence of Abnormal Postures in Parkinson's Disease (POSTUREinPD)

Prevalence of Abnormal Postures in Parkinson's Disease: an Observational Multicenter Study

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).

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease

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.

• Study Type: Observational
• Enrollment (Anticipated): 794

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy
    • Recruiting
    • Department of Experimental and Clinical Medicine - University "Politecnica delle Marche" Ancona -Italy. Neurorehabilitation Clinic - Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona.
    • Contact: Marianna Capecci, MD, PhD; Email: m.capecci@univpm.it
    • Sub-Investigator: Elisa Andrenelli, MD, PhD
  • Pescara, Italy
    • Recruiting
    • Department of Neuroscience, Imaging and Clinical Sciences, University G.d'Annunzio of Chieti-Pescara
    • Contact: Laura Bonanni, MD, PhD; Email: l.bonanni@unich.it
  • Pisa, Italy
    • Recruiting
    • Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
    • Contact: Roberto Ceravolo, MD, Professor; Email: r.ceravolo@med.unipi.it
  • Roma, Italy
    • Recruiting
    • IRCCS San Raffaele CTC Centro Parkinson Via della Pisana 235, 00163 Roma
    • Contact: Fabrizio Stocchi, MD; Email: fabrizio.stocchi@fastwebnet.it
  • Torino, Italy
    • Recruiting
    • Dipartimento di Neuroscienze A.O. Città della Salute e della Scienza di Torino
    • Contact: Maurizio Zibetti, MD; Email: maurizio.zibetti@gmail.com
  • Trieste, Italy
    • Recruiting
    • Clinica Neurologica, Dipartimento di Scienze Neurologiche, Chirurgiche e della Salute, Azienda Ospedaliera Universitaria integrata, Universita' di Trieste
    • Contact: Paolo Manganotti, MD, PhD; Email: pmanganotti@units.it
  • Verona, Italy, 37134
    • Recruiting
    • Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona
    • Contact: Michele Tinazzi, MD, PhD, Professor; Email: michele.tinazzi@univr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data of birth	(day/month/year);	1 day
Sex	(male/female)	1 day
Body Mass Index	(score)	1 day
SPECIFIC EVALUATION FOR PATIENTS WITH PARKINSON'S DISEASE • Age at PD onset	(years)	1 day
Disease duration of PD	(years)	1 day
Modified Hoehn and Yahr (H&Y);	Total score of Modified Hoehn and Yahr staging scale. It evaluates the stage of Parkinson's disease. Range= 1 to 5. Higher values represent worse stages of disease.	1 day
Unified Parkinson's Disease Rating Scale (UPDRS);	The Unified Parkinson's Disease Rating Scale evaluates the motor and non-motor symptoms of Parkinson's disease. Range= 0 to 260. Higher values represent worse symptoms of disease.	1 day
PD phenotype	(rigid acinetic; tremor; mixed type)	1 day
Laterality of motor symptoms at PD onset	(right, left, bilateral);	1 day
Clinical asymmetry	(number of patients)	1 day
Quality of life by means of Parkinson's Disease Questionnaire-8;	Parkinson's Disease Questionnaire-8 evaluates quality of life in patients with Parkinson's disease. Range= 0 to 100. Higher values represent worse quality of life.	1 day
Latency between PD onset and start of antiparkinsonian therapy	(years)	1 day
Pharmacologic treatment at disease onset of PD	(levodopa; dopaminoagonists; L-Dopa + dopaminoagonist; other therapies)	1 day
Ongoing pharmacological therapy	(levodopa; dopaminoagonists; L-Dopa + dopaminoagonist; other therapies)	1 day
Levodopa equivalent daily dose	(mg)	1 day
Number of falls and direction	(number, anterior, posterior, right, left)	1 day
Comorbilities	(heart diseases, malignancies, diabetes, hypertension, mental disorders, obesity, metabolic disorders, cerebrovascular diseases, physical trauma)	1 day
Associated medical conditions	(osteoporosis, arthrosis, rheumatic diseases, otovestibular disorders)	1 day
Visual Analogue Scale (VAS)	Visual Analogue Scale evaluates pain intensity. Range= 0 to 10. Higher values represent higher pain intensity.	1 day
SPECIFIC EVALUATION FOR PATIENTS WITH ABNORMAL POSTURES Type of deformity	(Pisa syndrome, camptocormia, anterocollis, scoliosis, striatal deformities)	1 day
Degrees	(wall goniometer and pictures with software-based analysis)	1 day
Latency to develop one or more postural deformity after PD onset	(months)	1 day
Postural deformity duration	(years)	1 day
The pattern of postural deformity onset	(acute, subacute, chronic)	1 day
Postural deformity after drug modification	(yes/no)	1 day
Postural deformity awareness	(yes/no)	1 day
Head compensation	(in case of PS, CP, AC)	1 day
Neck head on trunk angle	(degrees)	1 day
Neck tilt angle	(degrees)	1 day
Head tilt angle	(degrees)	1 day
Gaze angle (in case of AC)	(degrees)	1 day
Ankle and hip flexion (in case of CP)	(degrees)	1 day
Sensory trick	(yes/no)	1 day
Postural deformity direction only for PS	(right/left)	1 day
The presence of metronome sign (in case of PS)	(yes, no)	1 day
Side of PD symptoms at onset and PS inclination	(ipsilateral, contralateral, bilateral)	1 day
Side of PD symptoms at onset and hands/feet deformities	(ipsilateral, contralateral, bilateral)	1 day

Collaborators and Investigators

• Sponsor: Universita di Verona
• Investigators: Principal Investigator: Michele Tinazzi, MD, PhD, Professor, Universita di Verona; Study Chair: Nicola Smania, MD, Professor, Universita di Verona; Study Chair: Marialuisa Gandolfi, MD, PhD, Universita di Verona; Study Chair: Christian Geroin, PhD, Universita di Verona

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Anticipated): October 7, 2018
• Study Completion (Anticipated): October 7, 2018

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 14, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Parkinson Disease; Pisa Syndrome; Camptocormia; Antecollis; Striatal deformities
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Università di Verona

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No