Prevalence of Abnormal Postures in Parkinson's Disease

Parkinson Disease Clinical Trial

— POSTUREinPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03573232
• Other study ID #: Università di Verona
• Status: Recruiting
• Start date: March 7, 2018
• Est. completion date: October 7, 2018

Study information

• Verified date: July 2018
• Source: Universita di Verona
• Contact: Michele Tinazzi, MD, PhD, Professor
• Phone: 0458124287
• Email: michele.tinazzi[@]univr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 794
• Est. completion date: October 7, 2018
• Est. primary completion date: October 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Italy	Department of Experimental and Clinical Medicine - University "Politecnica delle Marche" Ancona -Italy. Neurorehabilitation Clinic - Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona.	Ancona
Italy	Department of Neuroscience, Imaging and Clinical Sciences, University G.d'Annunzio of Chieti-Pescara	Pescara
Italy	Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy	Pisa
Italy	IRCCS San Raffaele CTC Centro Parkinson Via della Pisana 235, 00163 Roma	Roma
Italy	Dipartimento di Neuroscienze A.O. Città della Salute e della Scienza di Torino	Torino
Italy	Clinica Neurologica, Dipartimento di Scienze Neurologiche, Chirurgiche e della Salute, Azienda Ospedaliera Universitaria integrata, Universita' di Trieste	Trieste
Italy	Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & 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. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

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