- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03741959
Rehabilitation of Postural Abnormalities in Parkinson's Disease
Rehabilitation of Postural Abnormalities in Parkinson's Disease: a Single-blind, Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This RCT with two parallel group will be conducted according to the tenets of the Declaration of Helsinki, the guidelines for Good Clinical Practice, and the Consolidated Standards of Reporting Trials (CONSORT).
The target population will be patients with Parkinson Disease who attend to the Neurorehabilitation Unit (AOUI Verona) and the Unità Operativa Complessa (UOC) Neurology ward (AOUI Verona) where they will be assessed for eligibility.
Who satisfied inclusion and exclusion criteria were randomly allocated in one of two groups, the experimental group and control group. Each patient will undergo rehabilitation.
Before the start of the study authors designed the experimental and the control group protocols. Two physiotherapists, one for each group, carried out the rehabilitation procedures. Patients of both groups received 10 individual sessions (60 min/session, 2 sessions/week, five consecutive weeks). Treatments will be performed in the rehabilitative gym of the G.B. Rossi University Hospital Neurological Rehabilitation Unit.
For the statistical analysis, an intention to treat analysis will be used. Descriptive statistics included means, standard deviation and graphs. The Shapiro-Wilk test will be used to test data distribution. Parametric or non-parametric tests will be used for inferential statistics, accordingly. The T-Test for unpaired data (or the Mann-Whitney test) will be used for testing between-group differences at T0 and T1. For this purpose, the changes of the score (Δ) between T0-T1 will be computed. The T-Test for paired data (or Wilcoxon signed rank tests) will be used to compare within-group changes over time. The level of significance was set p<0.05. Software statistics SPSS 20.0 (IBM Statistical Package for Social Science (SPSS) Statistics for Windows, Version 20.0, Armonk, NY, USA).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Verona, Italy, 37134
- AOUI Verona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age higher than 18 years old:
- A medical diagnosis of PD confirmed according to the Movement disorders criteria;
- PS defined as at least 10 degrees of lateral trunk flexion that can be reduced by passive mobilization or supine positioning (PS≥10) (Doherty et. al., 2011);
- Camptocormia defined as a flexion (at least 5°) in the sagittal plane originating in the thoracolumbar spine, (classified as upper and lower), manifesting during standing and walking and completely subside in recumbent position (Pandey et. al., 2016);
- Hoehn & Yahr (H&Y) stage <4 in "ON" medication phase.
- Informed consent to participate in the study
Exclusion Criteria:
- Severe dyskinesia or "on-off" fluctuations;
- PD medication modification in the 3 months preceding enrollment into the study;
- Need for assistive devices to rise from a chair or bed; somatic sensation deficits involving the legs;
- Vestibular disorders or paroxysmal vertigo; other neurological, orthopaedic or cardiovascular co-morbidities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
The experimental group will undergo three groups of exercises: 1) active self-correction exercises (20 minutes) defined as the best possible trunk alignment the patient can achieved in the three-dimensional planes; 2) passive and active trunk stabilization exercises (20 minutes) to improve trunk biomechanical constraint and to counteract the evolution of the misalignment; 3) functional tasks (20 minutes) defined as functional exercises to train the automatic response to maintain the best alignment through the broadest possible range of challenging activities (Romano2015).Training will consist of individualized treatment 60 mins/day, 2 days/week, for 5 consecutive weeks.
|
Active self-correction exercises (20 minutes) to achieve the best possible trunk alignment the patient can achieve in the three-dimensional planes using visual, proprioceptive and EMG feedbacks. Passive and active trunk stabilization exercises (20 minutes) to improve trunk biomechanical constraint Functional tasks (20 minutes) defined as functional exercises to train the automatic response to maintain the best alignment through the broadest possible range of challenging activities (Romano2015). |
Active Comparator: Control
The control group will undergo strengthening exercises and gait training as the usual practice in Parkinson Disease.
Training will consist of individualized treatment 60 mins/day, 2 days/week, for 5 consecutive weeks (Bartolo et.
al., 2010).
|
Training consisted of passive and active trunk mobilization (10 minutes) followed by muscle stretching, and strengthening exercises, and gait training (50 minutes)(Bartolo et.
al., 2010).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the degrees of trunk deviation in the sagittal and coronal plane.
Time Frame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
|
Changes in the degree of trunk deviation in the sagittal and coronal plane will be assessed using a wall goniometer in standing position.
|
Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Gait speed (cm/sec)
Time Frame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
|
Changes in gait speed will be assessed using the Gait Rite System.
It is a computerized walkway providing temporal spatial gait analysis.
|
Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
|
Changes in the Percentage Difference of Sway (PDS)
Time Frame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
|
The PDS computed for sway velocity in the eyes open (eo) and eyes closed (ec) conditions.
A ratio close to zero or negative indicates that the magnitude of body sway is similar or smaller in the ec than in the eo condition .
On the contrary, positive values reflect a larger sway in the ec than in the eo condition.
|
Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
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Changes in the Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
|
It is a comprehensive assessment designed to monitor the burden and the extent of Parkinson Disease across the longitudinal disease course and provides a clinical end-point in clinical trials. It consists of four sections with a total summed score. Each item have 5 response options (0=normal; 4=severe symptoms/signs). The higher= greater impact of PD symptoms. The Unified Parkinson's Disease Rating Scale - part III (UPDRS III) subscale will be used to measure changes in the motor disability (score range, 0-33; the higher=worse symptoms). |
Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
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Changes in the Parkinson's Disease Questionnaire (PDQ-8)
Time Frame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
|
The PDQ-8 contains eight of the original 39 items of the PDQ-39; one item selected from each of the 8 scales (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communications and bodily discomfort).
It provides a reliable measure of overall health status and is ideal for studies in which a shorter questionnaire is preferred.
Each question is scored from 0-4 points and the scores are summed.
the summed scores are then divided by total possible score and given as a percentage score out of 100 (Score range, 32-100; the higher worse health status)
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Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
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The number of falls
Time Frame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
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Number of falls occured in the previous month.
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Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
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Changes in the Mini Balance Evaluation System test (Mini BESTest)
Time Frame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
|
It is a clinical balance assessment tool to target and identify 4 different balance control systems (anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait) so that specific rehabilitation approaches can be designed.
It is a 14-item test scored on a 3-level ordinal scale (0-2).
Total score range 0-32; the higher= better performance.
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Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
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Changes in the Numeric Pain Rating Scale (NPRS)
Time Frame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
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A numeric rating scale to measure the amount of pain that a patient feels ranges across a continuum from none (0) to an extreme amount of pain (10).
Total score range 0-10; the higher= worse performance.
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Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Michele Tinazzi, PhD, Universita di Verona
Publications and helpful links
General Publications
- Bartolo M, Serrao M, Tassorelli C, Don R, Ranavolo A, Draicchio F, Pacchetti C, Buscone S, Perrotta A, Furnari A, Bramanti P, Padua L, Pierelli F, Sandrini G. Four-week trunk-specific rehabilitation treatment improves lateral trunk flexion in Parkinson's disease. Mov Disord. 2010 Feb 15;25(3):325-31. doi: 10.1002/mds.23007.
- 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.
- Gandolfi M, Tinazzi M, Magrinelli F, Busselli G, Dimitrova E, Polo N, Manganotti P, Fasano A, Smania N, Geroin C. Four-week trunk-specific exercise program decreases forward trunk flexion in Parkinson's disease: A single-blinded, randomized controlled trial. Parkinsonism Relat Disord. 2019 Jul;64:268-274. doi: 10.1016/j.parkreldis.2019.05.006. Epub 2019 May 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REMoVE Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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