跳至主要内容
临床试验/NCT02756676
NCT02756676已完成不适用

Impact of an Intensive Multi-Disciplinary Rehabilitation Treatment on Quality Of Life in Subjects With Parkinson's Disease

Ospedale Generale Di Zona Moriggia-Pelascini2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2015年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
试验地点
2
主要终点
Parkinson Disease Questionnaire (PDQ39)

研究概览

简要总结

This study is aimed to evaluate the impact of an intensive, multidisciplinary rehabilitative program on quality of life in patients with Parkinson's Disease.

详细描述

Parkinson's Disease (PD) is a progressive neurodegenerative disease clinically characterized by rigidity, bradykinesia and resting tremor. Beyond these symptoms the principal feature of this condition is the lost of habitual automatic movements and the disruption of different cognitive-motivational processes. These features are related to a pathological dopaminergic tone that alters the cortico-striatal pathways with several consequences on motor and emotional behaviours. Given its complexity PD impact very seriously on patients' quality of life (QoL).

Dopamine replacement therapy (DRT) is the standard treatment for the motor symptom of PD and previous studies have demonstrated its positive effect on QoL. However DRT does not reduce axial PD symptoms such as freezing of gait, postural instability and balance disturbances. Further, long-term DRT could negatively impact on cognitive and motivational functions and leads to different motor and behavioural side effects.

In the last years, rehabilitation has been proposed as an effective and complementary treatment for the management of PD and several evidences highlighted the need of a multidisciplinary and intensive approach to achieve good results.

To evaluate the impact of an intensive, multidisciplinary rehabilitation treatment (MIRT), on QoL of subjects with PD. Literature data showed that this type of treatment determine a positive effect on both motor and non-motor symptoms. Starting from these evidences, in this study the investigators have examined whether MIRT act positively on QoL and for how long this potential positive effect is maintained.

250 PD patients with Parkinson's Disease hospitalized for a 4-weeks MIRT were enrolled. PDQ39 was administered at enrolment, and at three points after discharge: at 1, 3 and 6 months. The investigators decided to evaluate QoL after homecoming in order to avoid an inpatient state bias. Other outcome measures were considered and assessed at the enrolment and at discharge: Unified Parkinson's Disease Scale (UPDRS), Parkinson Disease Disability Scale (PDDS), Berg Balance Scale (BBS), FOG (Freezing of Gait Questionnaire), 6MWT (6 minutes walking Test), Time Up and Go test (TUG). Cognitive and psychopathological status of patients was also assessed using Mini Mental State Examination (MMSE), Frontal Assessment Battery (FAB), State Trait Anxiety Inventory (STAY I-II), Beck Depression Inventory (BDI).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Parkinson Disease
  • MMSE ≥ 24

排除标准

  • Co-morbidity with other neurological disease
  • Visual and auditory dysfunctions

结局指标

主要结局

Parkinson Disease Questionnaire (PDQ39)

时间窗: 6 month

The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better QoL

次要结局

  • Unified Parkinson's disease Rating Scale (UPDRS)(6 month)
  • six minute walking test (6MWT)(6 month)
  • Freezing of Gait Questionnaire (FoG)(6 month)
  • Parkinson Disease Disability Scale(6 month)
  • Berg Balance Scale (BBS)(6 month)

研究者

发起方
Ospedale Generale Di Zona Moriggia-Pelascini
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilaria Zivi

MD

Ospedale Generale Di Zona Moriggia-Pelascini

研究点 (2)

Loading locations...

相似试验

Impact of Rehabilitation in Quality of Life in PD | 临床试验