Impact of Intensive Outpatient Rehabilitation on Non-Motor Patient-Reported Outcomes in Parkinson's Disease: The INTENSO Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Changes in Non-motor Symptoms
研究概览
简要总结
This historical cohort study aims to evaluate the impact of different intensity rehabilitation protocols on the short and medium-term severity of non-motor symptoms in patients with Parkinson's Disease. One of the principal strengths of this study is that it is a real-life study, so it has a high external validity necessary to test the clinical effectiveness of these two types of training, which could have significant practical implications for rehabilitation in Parkinson's disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults diagnosed with Idiopathic PD, Hoehn & Yahr stage ≥ 1 < 5, consecutive referral to the rehabilitation facility between 1 January 2014 and 31 December 2019 to receive outpatient physiotherapy treatment for the management of motor disability, specifically targeting gait, balance, or posture disorders;
- •completion of the course of rehabilitation treatment;
- •availability of Non-Motor Symptom Scale and Unified Parkinson's Disease Rating Scale, recorded before and after treatment and 6 plus or minus 1 months later
排除标准
- •diagnosis of any primary or secondary parkinsonism rather than PD
- •symptom onset since less than three years
- •any concomitant neurological disease (e.g. polyneuropathy, stroke, etc)
- •any other chronically disabling disease (e.g. severe heart, liver or kidney failure, cancer, psychiatric disorders, limb amputation, severe musculoskeletal or neuropathic pain)
- •changes in antiparkinsonian drug therapy during the whole study period
- •exposure to a course of physiotherapy during the 6 months preceding the study
结局指标
主要结局
Changes in Non-motor Symptoms
时间窗: before treatment, immediately after treatment, and six months following the end of the treatment
The changes in non-motor symptoms mesaured by the Unified Parkinson's Disease Rating Scale part I ( UPDRS part I; score range 0-52; higher scores mean a worse outcome)
次要结局
- Changes in Parkinson's Disease related disability(before treatment, immediately after treatment, and six months following the end of the treatment)
- Changes in motor symptoms severity(before treatment, immediately after treatment, and six months following the end of the treatment)
- Changes in the severity of the Freezing of Gait(before treatment, immediately after treatment, and six months following the end of the treatment)
研究者
Marianna Capecci, PhD
Professor
Università Politecnica delle Marche