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

July 14, 2018 updated by: Michele Tinazzi, MD, PhD, Universita di Verona

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
794

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Ancona, Italy
        • Recruiting
        • Department of Experimental and Clinical Medicine - University "Politecnica delle Marche" Ancona -Italy. Neurorehabilitation Clinic - Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona.
        • Contact:
        • Sub-Investigator:
          • Elisa Andrenelli, MD, PhD
      • Pescara, Italy
        • Recruiting
        • Department of Neuroscience, Imaging and Clinical Sciences, University G.d'Annunzio of Chieti-Pescara
        • Contact:
      • Pisa, Italy
        • Recruiting
        • Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
        • Contact:
      • Roma, Italy
        • Recruiting
        • IRCCS San Raffaele CTC Centro Parkinson Via della Pisana 235, 00163 Roma
        • Contact:
      • Torino, Italy
        • Recruiting
        • Dipartimento di Neuroscienze A.O. Città della Salute e della Scienza di Torino
        • Contact:
      • Trieste, Italy
        • Recruiting
        • Clinica Neurologica, Dipartimento di Scienze Neurologiche, Chirurgiche e della Salute, Azienda Ospedaliera Universitaria integrata, Universita' di Trieste
        • Contact:
      • Verona, Italy, 37134
        • Recruiting
        • Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Data of birth
Time Frame: 1 day
(day/month/year);
1 day
Sex
Time Frame: 1 day
(male/female)
1 day
Body Mass Index
Time Frame: 1 day
(score)
1 day
SPECIFIC EVALUATION FOR PATIENTS WITH PARKINSON'S DISEASE • Age at PD onset
Time Frame: 1 day
(years)
1 day
Disease duration of PD
Time Frame: 1 day
(years)
1 day
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.
1 day
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.
1 day
PD phenotype
Time Frame: 1 day
(rigid acinetic; tremor; mixed type)
1 day
Laterality of motor symptoms at PD onset
Time Frame: 1 day
(right, left, bilateral);
1 day
Clinical asymmetry
Time Frame: 1 day
(number of patients)
1 day
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.
1 day
Latency between PD onset and start of antiparkinsonian therapy
Time Frame: 1 day
(years)
1 day
Pharmacologic treatment at disease onset of PD
Time Frame: 1 day
(levodopa; dopaminoagonists; L-Dopa + dopaminoagonist; other therapies)
1 day
Ongoing pharmacological therapy
Time Frame: 1 day
(levodopa; dopaminoagonists; L-Dopa + dopaminoagonist; other therapies)
1 day
Levodopa equivalent daily dose
Time Frame: 1 day
(mg)
1 day
Number of falls and direction
Time Frame: 1 day
(number, anterior, posterior, right, left)
1 day
Comorbilities
Time Frame: 1 day
(heart diseases, malignancies, diabetes, hypertension, mental disorders, obesity, metabolic disorders, cerebrovascular diseases, physical trauma)
1 day
Associated medical conditions
Time Frame: 1 day
(osteoporosis, arthrosis, rheumatic diseases, otovestibular disorders)
1 day
Visual Analogue Scale (VAS)
Time Frame: 1 day
Visual Analogue Scale evaluates pain intensity. Range= 0 to 10. Higher values represent higher pain intensity.
1 day
SPECIFIC EVALUATION FOR PATIENTS WITH ABNORMAL POSTURES Type of deformity
Time Frame: 1 day
(Pisa syndrome, camptocormia, anterocollis, scoliosis, striatal deformities)
1 day
Degrees
Time Frame: 1 day
(wall goniometer and pictures with software-based analysis)
1 day
Latency to develop one or more postural deformity after PD onset
Time Frame: 1 day
(months)
1 day
Postural deformity duration
Time Frame: 1 day
(years)
1 day
The pattern of postural deformity onset
Time Frame: 1 day
(acute, subacute, chronic)
1 day
Postural deformity after drug modification
Time Frame: 1 day
(yes/no)
1 day
Postural deformity awareness
Time Frame: 1 day
(yes/no)
1 day
Head compensation
Time Frame: 1 day
(in case of PS, CP, AC)
1 day
Neck head on trunk angle
Time Frame: 1 day
(degrees)
1 day
Neck tilt angle
Time Frame: 1 day
(degrees)
1 day
Head tilt angle
Time Frame: 1 day
(degrees)
1 day
Gaze angle (in case of AC)
Time Frame: 1 day
(degrees)
1 day
Ankle and hip flexion (in case of CP)
Time Frame: 1 day
(degrees)
1 day
Sensory trick
Time Frame: 1 day
(yes/no)
1 day
Postural deformity direction only for PS
Time Frame: 1 day
(right/left)
1 day
The presence of metronome sign (in case of PS)
Time Frame: 1 day
(yes, no)
1 day
Side of PD symptoms at onset and PS inclination
Time Frame: 1 day
(ipsilateral, contralateral, bilateral)
1 day
Side of PD symptoms at onset and hands/feet deformities
Time Frame: 1 day
(ipsilateral, contralateral, bilateral)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universita di Verona

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 7, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Università di Verona

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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