AzTrials
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Parkinson DiseasePOSTUREinPDNCT03573232

Prevalence of Abnormal Postures in Parkinson's Disease

An observational study of Parkinson Disease, run by Universita di Verona at 7 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
How many people
794 participants
Where
7 sitesItaly
Study dates
7 Mar 2018to 7 Oct 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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;

Trial locations and contacts

7 sites in 1 country.

Michele Tinazzi, MD, PhD, Professor contact

0458124287

michele.tinazzi@univr.it

Christian Geroin, PhD contact

christian.geroin@univr.it

7 sites in 1 country

Italy7 sites, 7 recruiting

  • Department of Experimental and Clinical Medicine - University "Politecnica delle Marche" Ancona -Italy. Neurorehabilitation Clinic - Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona.

    Ancona

    Marianna Capecci, MD, PhD, m.capecci@univpm.it

    Elisa Andrenelli, MD, PhD

    Recruiting

  • Department of Neuroscience, Imaging and Clinical Sciences, University G.d'Annunzio of Chieti-Pescara

    Pescara

    Laura Bonanni, MD, PhD, l.bonanni@unich.it

    Recruiting

  • Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy

    Pisa

    Roberto Ceravolo, MD, Professor, r.ceravolo@med.unipi.it

    Recruiting

  • IRCCS San Raffaele CTC Centro Parkinson Via della Pisana 235, 00163 Roma

    Roma

    Fabrizio Stocchi, MD, fabrizio.stocchi@fastwebnet.it

    Recruiting

  • Dipartimento di Neuroscienze A.O. Città della Salute e della Scienza di Torino

    Torino

    Maurizio Zibetti, MD, maurizio.zibetti@gmail.com

    Recruiting

  • Clinica Neurologica, Dipartimento di Scienze Neurologiche, Chirurgiche e della Salute, Azienda Ospedaliera Universitaria integrata, Universita' di Trieste

    Trieste

    Paolo Manganotti, MD, PhD, pmanganotti@units.it

    Recruiting

  • Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona

    Verona, 37134

    Michele Tinazzi, MD, PhD, Professor, michele.tinazzi@univr.it

    Recruiting

Other trials in Italy

About this study

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

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).

Read the 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.

Keywords
Parkinson Disease, Pisa Syndrome, Camptocormia, Antecollis, Striatal deformities
Medical subject headings
Parkinson Disease, Camptocormia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The prevalence of postural deformities

    % of people with Parkinson's disease reporting Pisa syndrome, camptocormia, antecollis, scoliosis and striatal deformities related to hand (striatal hand) and toes (striatal toes).

    Measured: 1 day

Secondary outcomes (37)

  1. Data of birth

    (day/month/year);

    Measured: 1 day

  2. Sex

    (male/female)

    Measured: 1 day

  3. Body Mass Index

    (score)

    Measured: 1 day

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

    (years)

    Measured: 1 day

  5. Disease duration of PD

    (years)

    Measured: 1 day

  6. Modified Hoehn and Yahr (H&Y);

    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.

    Measured: 1 day

  7. Unified Parkinson's Disease Rating Scale (UPDRS);

    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.

    Measured: 1 day

  8. PD phenotype

    (rigid acinetic; tremor; mixed type)

    Measured: 1 day

  9. Laterality of motor symptoms at PD onset

    (right, left, bilateral);

    Measured: 1 day

  10. Clinical asymmetry

    (number of patients)

    Measured: 1 day

  11. Quality of life by means of Parkinson's Disease Questionnaire-8;

    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.

    Measured: 1 day

  12. Latency between PD onset and start of antiparkinsonian therapy

    (years)

    Measured: 1 day

  13. Pharmacologic treatment at disease onset of PD

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

    Measured: 1 day

  14. Ongoing pharmacological therapy

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

    Measured: 1 day

  15. Levodopa equivalent daily dose

    (mg)

    Measured: 1 day

  16. Number of falls and direction

    (number, anterior, posterior, right, left)

    Measured: 1 day

  17. Comorbilities

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

    Measured: 1 day

  18. Associated medical conditions

    (osteoporosis, arthrosis, rheumatic diseases, otovestibular disorders)

    Measured: 1 day

  19. Visual Analogue Scale (VAS)

    Visual Analogue Scale evaluates pain intensity. Range= 0 to 10. Higher values represent higher pain intensity.

    Measured: 1 day

  20. SPECIFIC EVALUATION FOR PATIENTS WITH ABNORMAL POSTURES Type of deformity

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

    Measured: 1 day

  21. Degrees

    (wall goniometer and pictures with software-based analysis)

    Measured: 1 day

  22. Latency to develop one or more postural deformity after PD onset

    (months)

    Measured: 1 day

  23. Postural deformity duration

    (years)

    Measured: 1 day

  24. The pattern of postural deformity onset

    (acute, subacute, chronic)

    Measured: 1 day

  25. Postural deformity after drug modification

    (yes/no)

    Measured: 1 day

  26. Postural deformity awareness

    (yes/no)

    Measured: 1 day

  27. Head compensation

    (in case of PS, CP, AC)

    Measured: 1 day

  28. Neck head on trunk angle

    (degrees)

    Measured: 1 day

  29. Neck tilt angle

    (degrees)

    Measured: 1 day

  30. Head tilt angle

    (degrees)

    Measured: 1 day

  31. Gaze angle (in case of AC)

    (degrees)

    Measured: 1 day

  32. Ankle and hip flexion (in case of CP)

    (degrees)

    Measured: 1 day

  33. Sensory trick

    (yes/no)

    Measured: 1 day

  34. Postural deformity direction only for PS

    (right/left)

    Measured: 1 day

  35. The presence of metronome sign (in case of PS)

    (yes, no)

    Measured: 1 day

  36. Side of PD symptoms at onset and PS inclination

    (ipsilateral, contralateral, bilateral)

    Measured: 1 day

  37. Side of PD symptoms at onset and hands/feet deformities

    (ipsilateral, contralateral, bilateral)

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2018
  2. Study start7 Mar 2018
  3. Primary completion7 Oct 2018 (estimated)
  4. Study completion7 Oct 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
794 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03573232
Sponsor's protocol ID
Università di Verona
Acronym
POSTUREinPD
Status last verified
Jul 2018
First submitted
7 May 2018
Last updated
17 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Doherty KM, van de Warrenburg BP, Peralta MC, Silveira-Moriyama L, Azulay JP, Gershanik OS, Bloem BR. Postural deformities in Parkinson's disease. Lancet Neurol. 2011 Jun;10(6):538-49. doi: 10.1016/S1474-4422(11)70067-9. Epub 2011 Apr 22.

    PubMed 21514890

  • Tinazzi M, Geroin C, Gandolfi M, Smania N, Tamburin S, Morgante F, Fasano A. Pisa syndrome in Parkinson's disease: An integrated approach from pathophysiology to management. Mov Disord. 2016 Dec;31(12):1785-1795. doi: 10.1002/mds.26829. Epub 2016 Oct 25.

    PubMed 27779784

  • Srivanitchapoom P, Hallett M. Camptocormia in Parkinson's disease: definition, epidemiology, pathogenesis and treatment modalities. J Neurol Neurosurg Psychiatry. 2016 Jan;87(1):75-85. doi: 10.1136/jnnp-2014-310049. Epub 2015 Apr 20.

    PubMed 25896683

  • Pandey S, Garg H. Postural & striatal deformities in Parkinson;s disease: Are these rare? Indian J Med Res. 2016 Jan;143(1):11-7. doi: 10.4103/0971-5916.178577.

    PubMed 26997007

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Universita di Verona at 7 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michele Tinazzi, MD, PhD, Professor (0458124287, michele.tinazzi@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The prevalence of postural deformities (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03573232, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.

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