Destination Sequence Effect Modifications After a 4-week Rehabilitation Program in Parkinson's Diseases Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Destination sequence effect (dSE) modifications
研究概览
简要总结
The sequence effect (SE), defined as a reduction in amplitude of repetitive movements, is a common clinical feature of Parkinson's disease (PD), being a major contributor to freezing of gait (FOG). During walking, SE manifests as a step-by-step reduction in step length when approaching a turn or gait destination (dSE). The investigators studied the effect of a 4-week rehabilitation program on the destination sequence effect in patients affected by Parkinson's disease with and without Freezing of Gait. All subjects were evaluated with inertial gait analysis for dSE recording.
详细描述
Gait impairment and freezing of gait (FOG) represent common and disabling symptoms of Parkinson's disease (PD). The antiparkinsonian therapy positively modulates a subset of gait parameters, such as speed of gait and stride length, while its impact on FOG is limited. Growing evidence supports the efficacy of neurorehabilitation in the treatment of PD across all phases of the disease. In the last years, the advent of reliable wearable devices has prompted the widespread study of several parameters of the parkinsonian gait in both clinical and research settings.
The sequence effect (SE), defined as a reduction in amplitude of repetitive movements, is a common clinical feature of several tasks of patients affected by PD, being identifiable in early as well as advanced stages of the disease. During walking, SE manifests as a step-by-step reduction in step length when approaching a turn or gait destination (destination sequence effect - dSE). SE is specifically pronounced in PD patients affected by FOG, and it arises immediately before a FOG episode induced by a turning or a dual-task.
SE may be acutely modulated by several rehabilitative strategies such as split-belt treadmill and reinforcement of visual cues, but not by repetitive transcranial magnetic stimulation (rTMS), antiparkinsonian drugs administration, and attention strategies did not influence the SE, the evidence on the role of neurorehabilitation on gait SE improvement and retention is extremely scarce.
The investigators plan to enroll 43 subjects according to sample size calculation. Patients will be divided into two groups: patients with freezing of gait (FOG) and without FOG. The subjects will be divided into two groups: 1) patients with freezing of gait (PD+FOG), or 2) patients without freezing of gait (PD-FOG). FOG phenotype is defined as: a score between 1 and 4 at either item "2.13 Freezing" or item "3.11 Freezing of gait" of the Unified Parkinson Disease Rating Scale (UPDRS).
All patients will be treated with a standardized 4-week rehabilitation in-hospital program. At hospital admission (T0), patients who fulfill inclusion/exclusion criteria will be tested with instrumental gait analysis and administration of a set of the following clinical scales: rating of PD related motor disability with the Unified Parkinson's Disease Rating Scale - part III (UPDRS-III); rating of functional independence as measured through the Functional Independence Measure (FIM); and rating of dependence in activity of daily living according to Barthel Index.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Idiopathic Parkinson's disease
- •Hoehn and Yahr stage between I and IV
- •Mini-Mental State Examination score above 24.
排除标准
- •Major psychiatric or other neurological conditions,
- •Rheumatological diseases
- •Ophthalmic diseases
- •Orthopedic diseases
- •Ongoing or previous treatment with neuroleptic drugs
- •Patients with deep brain stimulation
- •Any change in dose or regimen of the anti-parkinsonian therapy in the last month before enrolment.
结局指标
主要结局
Destination sequence effect (dSE) modifications
时间窗: Change from baseline (T0) to four weeks (T1)
Using an inertial gait analysis we will explore the modifications of destination sequence effect in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
次要结局
- Gait hypokinesia modifications(Change from baseline (T0) to four weeks (T1))
- Double support modifications(Change from baseline (T0) to four weeks (T1))
- Between-group comparison of dSE(Baseline (T0))
- Cadence modifications(Change from baseline (T0) to four weeks (T1))
- Stance modifications(Change from baseline (T0) to four weeks (T1))
- Swing modifications(Change from baseline (T0) to four weeks (T1))
- Motor disability improvement(Change from baseline (T0) to four weeks (T1))
- Stride duration modifications(Change from baseline (T0) to four weeks (T1))
- Speed modifications(Change from baseline (T0) to four weeks (T1))
- Stride lenght modifications(Change from baseline (T0) to four weeks (T1))
- Single support modifications(Change from baseline (T0) to four weeks (T1))
- Dependence in activity of daily living improvement(Change from baseline (T0) to four weeks (T1))
- Functional Independence improvement(Change from baseline (T0) to four weeks (T1))