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临床试验/NCT03573232
NCT03573232Unknown不适用

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

Universita di Verona7 个研究点 分布在 1 个国家目标入组 794 人开始时间: 2018年3月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
794
试验地点
7
主要终点
The prevalence of postural deformities

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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;

结局指标

主要结局

The prevalence of postural deformities

时间窗: 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).

次要结局

  • 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)

研究者

发起方
Universita di Verona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele Tinazzi, MD, PhD

M.D., Ph.D. Full Professor

Universita di Verona

研究点 (7)

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