Parkinson Disease Clinical Trial
Official title:
Rehabilitation of Postural Abnormalities in Parkinson's Disease: a Single-blind, Randomised Controlled Trial
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.
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).
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