Rehabilitation of Postural Abnormalities in Parkinson's Disease: a Single-blind, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in the degrees of trunk deviation in the sagittal and coronal plane.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will be blinded. Patients will be specifically asked not to discuss their treatment during assessments. Examiner will be requested to inform the research coordinator if he will discover to which group a patient belonged, and they will periodically be questioned by the coordinator about this.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Experimental group (Procedure)
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).
干预措施: Control group (Procedure)
结局指标
主要结局
Changes in the degrees of trunk deviation in the sagittal and coronal plane.
时间窗: 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.
次要结局
- Changes in Gait speed (cm/sec)(Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up)
- Changes in the Percentage Difference of Sway (PDS)(Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up)
- Changes in the Parkinson's Disease Questionnaire (PDQ-8)(Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up)
- The number of falls(Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up)
- Changes in the Numeric Pain Rating Scale (NPRS)(Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up)
- Changes in the Unified Parkinson's Disease Rating Scale (UPDRS)(Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up)
- Changes in the Mini Balance Evaluation System test (Mini BESTest)(Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up)
研究者
Nicola Smania, MD, Clinical Professor
Head of UOC Neurorehabilitation
Universita di Verona