Management of Initial Parkinson's Disease: a Prospective, Mono-centric, no Profit Pilot Clinical Trial Comparing Conventional Face-to-face Physiotherapy and Home-based Telerehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Single arm recruitment potentials
研究概览
简要总结
The Parkinson TELEREHABilitation-NET pilot study (Parkinson TELEREHAB-NET) is designed to observe and monitor PD patients in their initial phase (which includes the period from the onset of motor symptoms until the onset of motor fluctuations) and to assess the feasibility of an integrated multidimensional approach in treating and managing PD patients in a local clinical setting (ASL CN1). Chiefly, through this pilot study, feasibility and acceptability of the general experimental plan, as well as the potential for positive effects of physiotherapy in early PD patients will be assessed.
So, this pilot study primarily aims at:
- validating the feasibility of the study protocol, assessing participants' inclusion and exclusion criteria, testing instruments/procedures used for home rehabilitation (both for the Telerehabilitation Exercise group - TrE arm and for the Home Self-Exercise group - HSE arm), testing the suitability of the method for data collection;
- obtaining the required preliminary data for the calculation of a sample size for the primary outcome, in both arms;
- evaluating appropriateness of the consent form, recruitment potentials, time needed to receive written consent, and the required number of researchers/medical specialists/physiotherapists needed to cover the whole study path;
- assessing patients' acceptability of the intervention, through the evaluation of the adherence to rehabilitation process (in both arms), the completeness of proposed measurements, and compliance at follow-up.
Secondary objectives are the monitoring of patients' perceived quality of life, and of motor performance and non-motor symptoms through specific rating scales, after completing the whole rehabilitation path (described below) compared to baseline level, and maintenance of results over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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, aged 18 or older;
- •medical diagnosis of idiopathic PD according the most recent Movement Disorder Society diagnostic criteria;
- •disease stage ≤ 2 on the Hoehn&Yahr scale;
- •Montreal Cognitive Assessment score >25;
- •ability to read, understand and provide a written informed consent, in accordance with good clinical practice and local regulations;
- •motivation and possibility to show up for planned controls and to comply with the requested study procedures.
- •Specific for TrE arm:
- •wireless internet access at home;
- •adequate room to place telerehabilitation device (about 2 meters in front of device monitor).
排除标准
- •<18 years of age;
- •Any atypical, iatrogenic, or secondary Parkinsonism;
- •Disease stage > 2 on the Hoehn&Yahr scale;
- •Any severe orthopaedic, vascular, respiratory, or cardiac problems or any other medical condition that, in the principal investigator's opinion, could limit participation in moderate exercise or the study protocol.
结局指标
主要结局
Single arm recruitment potentials
时间窗: baseline
arm-specific number of enrolled subjects / arm-specific number of eligible subjects
Compliance to interventions
时间窗: at end of outpatient intensive exercise program (4 weeks from baseline), after training at home (8 weeks from baseline), and for home-based training (follow-ups at 6 months and at 12 months from baseline)
number of fulfilled visits / number of scheduled visits
Study recruitment potentials
时间窗: baseline
total number of enrolled subjects / total number of eligible subjects
Adherence to study path
时间窗: at end of outpatient intensive exercise program (4 weeks from baseline), after training at home (8 weeks from baseline), and for home-based training (follow-ups at 6 months and at 12 months from baseline)
drop-out rate at each single step, total and by arm
次要结局
- Transition ability between sitting and standing(after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline))
- Manual dexterity(after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline))
- Transition ability between standing and prone position(after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline))
- Cognitive functions(from baseline to follow-ups (at 6 months and at 12 months from baseline))
- Freezing of gait(from baseline to follow-ups (at 6 months and at 12 months from baseline))
- Dynamic stability(after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline))
- Movement disorders(from baseline to follow-ups (at 6 months and at 12 months from baseline))
- Postural control(from baseline to follow-ups (at 6 months and at 12 months from baseline))
- Sensory orientation(from baseline to follow-ups (at 6 months and at 12 months from baseline))
- Backward walking ability(after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline))
- Quality of life perception(from baseline to follow-ups (at 6 months and at 12 months from baseline))
- Walking ability(after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline))
- Turning ability(after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline))