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Clinical Trials/NCT03573232
NCT03573232
Unknown
Not Applicable

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

Universita di Verona7 sites in 1 country794 target enrollmentMarch 7, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Universita di Verona
Enrollment
794
Locations
7
Primary Endpoint
The prevalence of postural deformities
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 7, 2018
End Date
October 7, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Universita di Verona
Responsible Party
Principal Investigator
Principal Investigator

Michele Tinazzi, MD, PhD

M.D., Ph.D. Full Professor

Universita di Verona

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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;

Outcomes

Primary Outcomes

The prevalence of postural deformities

Time Frame: 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 Outcomes

  • Head tilt angle(1 day)
  • Gaze angle (in case of AC)(1 day)
  • The presence of metronome sign (in case of PS)(1 day)
  • Body Mass Index(1 day)
  • PD phenotype(1 day)
  • Ongoing pharmacological therapy(1 day)
  • Number of falls and direction(1 day)
  • Pharmacologic treatment at disease onset of PD(1 day)
  • Sensory trick(1 day)
  • Postural deformity duration(1 day)
  • Sex(1 day)
  • SPECIFIC EVALUATION FOR PATIENTS WITH PARKINSON'S DISEASE • Age at PD onset(1 day)
  • Disease duration of PD(1 day)
  • Clinical asymmetry(1 day)
  • Associated medical conditions(1 day)
  • SPECIFIC EVALUATION FOR PATIENTS WITH ABNORMAL POSTURES Type of deformity(1 day)
  • Latency to develop one or more postural deformity after PD onset(1 day)
  • The pattern of postural deformity onset(1 day)
  • Postural deformity after drug modification(1 day)
  • Data of birth(1 day)
  • Levodopa equivalent daily dose(1 day)
  • Comorbilities(1 day)
  • Postural deformity direction only for PS(1 day)
  • Visual Analogue Scale (VAS)(1 day)
  • Neck head on trunk angle(1 day)
  • Modified Hoehn and Yahr (H&Y);(1 day)
  • Unified Parkinson's Disease Rating Scale (UPDRS);(1 day)
  • Laterality of motor symptoms at PD onset(1 day)
  • Degrees(1 day)
  • Head compensation(1 day)
  • Ankle and hip flexion (in case of CP)(1 day)
  • Postural deformity awareness(1 day)
  • Quality of life by means of Parkinson's Disease Questionnaire-8;(1 day)
  • Latency between PD onset and start of antiparkinsonian therapy(1 day)
  • Neck tilt angle(1 day)
  • Side of PD symptoms at onset and PS inclination(1 day)
  • Side of PD symptoms at onset and hands/feet deformities(1 day)

Study Sites (7)

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