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

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ClinicalTrials.gov Identifier: NCT03573232
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Michele Tinazzi, MD, PhD, 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).

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 794 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Prevalence of Abnormal Postures in Parkinson's Disease: an Observational Multicenter Study
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : October 7, 2018
Estimated Study Completion Date : October 7, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Data of birth [ Time Frame: 1 day ]
    (day/month/year);

  2. Sex [ Time Frame: 1 day ]
    (male/female)

  3. Body Mass Index [ Time Frame: 1 day ]
    (score)

  4. SPECIFIC EVALUATION FOR PATIENTS WITH PARKINSON'S DISEASE • Age at PD onset [ Time Frame: 1 day ]
    (years)

  5. Disease duration of PD [ Time Frame: 1 day ]
    (years)

  6. Modified Hoehn and Yahr (H&Y); [ Time Frame: 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.

  7. Unified Parkinson's Disease Rating Scale (UPDRS); [ Time Frame: 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.

  8. PD phenotype [ Time Frame: 1 day ]
    (rigid acinetic; tremor; mixed type)

  9. Laterality of motor symptoms at PD onset [ Time Frame: 1 day ]
    (right, left, bilateral);

  10. Clinical asymmetry [ Time Frame: 1 day ]
    (number of patients)

  11. Quality of life by means of Parkinson's Disease Questionnaire-8; [ Time Frame: 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.

  12. Latency between PD onset and start of antiparkinsonian therapy [ Time Frame: 1 day ]
    (years)

  13. Pharmacologic treatment at disease onset of PD [ Time Frame: 1 day ]
    (levodopa; dopaminoagonists; L-Dopa + dopaminoagonist; other therapies)

  14. Ongoing pharmacological therapy [ Time Frame: 1 day ]
    (levodopa; dopaminoagonists; L-Dopa + dopaminoagonist; other therapies)

  15. Levodopa equivalent daily dose [ Time Frame: 1 day ]
    (mg)

  16. Number of falls and direction [ Time Frame: 1 day ]
    (number, anterior, posterior, right, left)

  17. Comorbilities [ Time Frame: 1 day ]
    (heart diseases, malignancies, diabetes, hypertension, mental disorders, obesity, metabolic disorders, cerebrovascular diseases, physical trauma)

  18. Associated medical conditions [ Time Frame: 1 day ]
    (osteoporosis, arthrosis, rheumatic diseases, otovestibular disorders)

  19. Visual Analogue Scale (VAS) [ Time Frame: 1 day ]
    Visual Analogue Scale evaluates pain intensity. Range= 0 to 10. Higher values represent higher pain intensity.

  20. SPECIFIC EVALUATION FOR PATIENTS WITH ABNORMAL POSTURES Type of deformity [ Time Frame: 1 day ]
    (Pisa syndrome, camptocormia, anterocollis, scoliosis, striatal deformities)

  21. Degrees [ Time Frame: 1 day ]
    (wall goniometer and pictures with software-based analysis)

  22. Latency to develop one or more postural deformity after PD onset [ Time Frame: 1 day ]
    (months)

  23. Postural deformity duration [ Time Frame: 1 day ]
    (years)

  24. The pattern of postural deformity onset [ Time Frame: 1 day ]
    (acute, subacute, chronic)

  25. Postural deformity after drug modification [ Time Frame: 1 day ]
    (yes/no)

  26. Postural deformity awareness [ Time Frame: 1 day ]
    (yes/no)

  27. Head compensation [ Time Frame: 1 day ]
    (in case of PS, CP, AC)

  28. Neck head on trunk angle [ Time Frame: 1 day ]
    (degrees)

  29. Neck tilt angle [ Time Frame: 1 day ]
    (degrees)

  30. Head tilt angle [ Time Frame: 1 day ]
    (degrees)

  31. Gaze angle (in case of AC) [ Time Frame: 1 day ]
    (degrees)

  32. Ankle and hip flexion (in case of CP) [ Time Frame: 1 day ]
    (degrees)

  33. Sensory trick [ Time Frame: 1 day ]
    (yes/no)

  34. Postural deformity direction only for PS [ Time Frame: 1 day ]
    (right/left)

  35. The presence of metronome sign (in case of PS) [ Time Frame: 1 day ]
    (yes, no)

  36. Side of PD symptoms at onset and PS inclination [ Time Frame: 1 day ]
    (ipsilateral, contralateral, bilateral)

  37. Side of PD symptoms at onset and hands/feet deformities [ Time Frame: 1 day ]
    (ipsilateral, contralateral, bilateral)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573232


Contacts
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Contact: Michele Tinazzi, MD, PhD, Professor 0458124287 michele.tinazzi@univr.it
Contact: Christian Geroin, PhD christian.geroin@univr.it

Locations
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Italy
Department of Experimental and Clinical Medicine - University "Politecnica delle Marche" Ancona -Italy. Neurorehabilitation Clinic - Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona. Recruiting
Ancona, Italy
Contact: Marianna Capecci, MD, PhD       m.capecci@univpm.it   
Sub-Investigator: Elisa Andrenelli, MD, PhD         
Department of Neuroscience, Imaging and Clinical Sciences, University G.d'Annunzio of Chieti-Pescara Recruiting
Pescara, Italy
Contact: Laura Bonanni, MD, PhD       l.bonanni@unich.it   
Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy Recruiting
Pisa, Italy
Contact: Roberto Ceravolo, MD, Professor       r.ceravolo@med.unipi.it   
IRCCS San Raffaele CTC Centro Parkinson Via della Pisana 235, 00163 Roma Recruiting
Roma, Italy
Contact: Fabrizio Stocchi, MD       fabrizio.stocchi@fastwebnet.it   
Dipartimento di Neuroscienze A.O. Città della Salute e della Scienza di Torino Recruiting
Torino, Italy
Contact: Maurizio Zibetti, MD       maurizio.zibetti@gmail.com   
Clinica Neurologica, Dipartimento di Scienze Neurologiche, Chirurgiche e della Salute, Azienda Ospedaliera Universitaria integrata, Universita' di Trieste Recruiting
Trieste, Italy
Contact: Paolo Manganotti, MD, PhD       pmanganotti@units.it   
Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona Recruiting
Verona, Italy, 37134
Contact: Michele Tinazzi, MD, PhD, Professor       michele.tinazzi@univr.it   
Sponsors and Collaborators
Universita di Verona
Investigators
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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:
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Responsible Party: Michele Tinazzi, MD, PhD, M.D., Ph.D. Full Professor, Universita di Verona
ClinicalTrials.gov Identifier: NCT03573232     History of Changes
Other Study ID Numbers: Università di Verona
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michele Tinazzi, MD, PhD, Universita di Verona:
Parkinson Disease
Pisa Syndrome
Camptocormia
Antecollis
Striatal deformities
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases