Clinical trial NCT03741959: Rehabilitation of Postural Abnormalities in Parkinson's Disease
Official title: Rehabilitation of Postural Abnormalities in Parkinson's Disease: a Single-blind, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: postural defect
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment. Single-blind RCT with two parallel group
Primary purpose: TREATMENT

Brief summary: Postural abnormalities (PA) are drug refractory complications in patients with Parkinson's disease (PD) leading to pain, imbalance, gait disorders and fall-related injuries. It ultimately affects the quality of life and the hospitalisation risk. the literature on treatment outcomes is scant. Rehabilitation is the cornerstone in the management of PD patients, especially for drug-refractory complications. However, the current efforts are only partially able to resolve PA in PD. Despite differences in methodologies, the few rehabilitative studies support the benefits of trunk rehabilitation in PD with PA. Priorities for future research include well-design rehabilitation studies on a large population. The early detection and early rehabilitation of PA might avoid fixed irreversible deformities and reduce the complications that can accompany them. It ultimately might improve the quality of life, reduce the risk of fall-related injuries and hospitalisation rate. A single-blind single-blind Randomised Controlled Trial (RCT) will evaluate the effects of trunk rehabilitation on PA severity, function and disability in outpatients with Parkinson Disease and postural abnormalities.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the degrees of trunk deviation in the sagittal and coronal plane.
timeFrame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
Secondary outcomes:
measure: Changes in Gait speed (cm/sec)
timeFrame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
measure: Changes in the Percentage Difference of Sway (PDS)
timeFrame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
measure: Changes in the Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
measure: Changes in the Parkinson's Disease Questionnaire (PDQ-8)
timeFrame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
measure: The number of falls
timeFrame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
measure: Changes in the Mini Balance Evaluation System test (Mini BESTest)
timeFrame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
measure: Changes in the Numeric Pain Rating Scale (NPRS)
timeFrame: Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AOUI Verona
Study officials:
affiliation: Universita di Verona
name: Michele Tinazzi, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.