POSTUREinPD: Prevalence of Abnormal Postures in Parkinson's Disease

Sponsor
Universita di Verona (Other)
Overall Status
Unknown status
CT.gov ID
NCT03573232
Collaborator
(none)
794
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Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated 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 :
    Mar 7, 2018
    Anticipated Primary Completion Date :
    Oct 7, 2018
    Anticipated Study Completion Date :
    Oct 7, 2018

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Data of birth [1 day]

      (day/month/year);

    2. Sex [1 day]

      (male/female)

    3. Body Mass Index [1 day]

      (score)

    4. SPECIFIC EVALUATION FOR PATIENTS WITH PARKINSON'S DISEASE • Age at PD onset [1 day]

      (years)

    5. Disease duration of PD [1 day]

      (years)

    6. 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.

    7. 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.

    8. PD phenotype [1 day]

      (rigid acinetic; tremor; mixed type)

    9. Laterality of motor symptoms at PD onset [1 day]

      (right, left, bilateral);

    10. Clinical asymmetry [1 day]

      (number of patients)

    11. 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.

    12. Latency between PD onset and start of antiparkinsonian therapy [1 day]

      (years)

    13. Pharmacologic treatment at disease onset of PD [1 day]

      (levodopa; dopaminoagonists; L-Dopa + dopaminoagonist; other therapies)

    14. Ongoing pharmacological therapy [1 day]

      (levodopa; dopaminoagonists; L-Dopa + dopaminoagonist; other therapies)

    15. Levodopa equivalent daily dose [1 day]

      (mg)

    16. Number of falls and direction [1 day]

      (number, anterior, posterior, right, left)

    17. Comorbilities [1 day]

      (heart diseases, malignancies, diabetes, hypertension, mental disorders, obesity, metabolic disorders, cerebrovascular diseases, physical trauma)

    18. Associated medical conditions [1 day]

      (osteoporosis, arthrosis, rheumatic diseases, otovestibular disorders)

    19. Visual Analogue Scale (VAS) [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 [1 day]

      (Pisa syndrome, camptocormia, anterocollis, scoliosis, striatal deformities)

    21. Degrees [1 day]

      (wall goniometer and pictures with software-based analysis)

    22. Latency to develop one or more postural deformity after PD onset [1 day]

      (months)

    23. Postural deformity duration [1 day]

      (years)

    24. The pattern of postural deformity onset [1 day]

      (acute, subacute, chronic)

    25. Postural deformity after drug modification [1 day]

      (yes/no)

    26. Postural deformity awareness [1 day]

      (yes/no)

    27. Head compensation [1 day]

      (in case of PS, CP, AC)

    28. Neck head on trunk angle [1 day]

      (degrees)

    29. Neck tilt angle [1 day]

      (degrees)

    30. Head tilt angle [1 day]

      (degrees)

    31. Gaze angle (in case of AC) [1 day]

      (degrees)

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

      (degrees)

    33. Sensory trick [1 day]

      (yes/no)

    34. Postural deformity direction only for PS [1 day]

      (right/left)

    35. The presence of metronome sign (in case of PS) [1 day]

      (yes, no)

    36. Side of PD symptoms at onset and PS inclination [1 day]

      (ipsilateral, contralateral, bilateral)

    37. Side of PD symptoms at onset and hands/feet deformities [1 day]

      (ipsilateral, contralateral, bilateral)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Experimental and Clinical Medicine - University "Politecnica delle Marche" Ancona -Italy. Neurorehabilitation Clinic - Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona. Ancona Italy
    2 Department of Neuroscience, Imaging and Clinical Sciences, University G.d'Annunzio of Chieti-Pescara Pescara Italy
    3 Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy Pisa Italy
    4 IRCCS San Raffaele CTC Centro Parkinson Via della Pisana 235, 00163 Roma Roma Italy
    5 Dipartimento di Neuroscienze A.O. Città della Salute e della Scienza di Torino Torino Italy
    6 Clinica Neurologica, Dipartimento di Scienze Neurologiche, Chirurgiche e della Salute, Azienda Ospedaliera Universitaria integrata, Universita' di Trieste Trieste Italy
    7 Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona Verona Italy 37134

    Sponsors and Collaborators

    • Universita di Verona

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Michele Tinazzi, MD, PhD, M.D., Ph.D. Full Professor, Universita di Verona
    ClinicalTrials.gov Identifier:
    NCT03573232
    Other Study ID Numbers:
    • Università di Verona
    First Posted:
    Jun 29, 2018
    Last Update Posted:
    Jul 17, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, M.D., Ph.D. Full Professor, Universita di Verona
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 17, 2018