Prevalence of Abnormal Postures in Parkinson's Disease

• Conditions: Parkinson Disease

• Registration Number: NCT03573232
• Lead Sponsor: Universita di Verona

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.

Study Timeline

• Study Start: 2018-03-07
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-29
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-14
• Last Update Posted: 2018-07-17
• Primary Completion: 2018-10-07
• Study Completion: 2018-10-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 794

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of postural deformities	1 day	% of people with Parkinson's disease reporting Pisa syndrome, camptocormia, antecollis, scoliosis and striatal deformities related to hand (striatal hand) and toes (striatal toes).

Secondary Outcome Measures

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

Trial Locations

Locations (7)

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

Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona; 🇮🇹 Verona, Italy

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

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