Home-Based Telesurveillance and Rehabilitation Program in Parkinson's Disease: Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Percentage of participants in the PTE group who will concluded the home-based program.
研究概览
简要总结
Parkinson's disease (PD) is a chronic neurodegenerative disease due to the loss of dopaminergic neurons in the substantia nigra, leading to motor symptoms of tremor, rigidity, and bradykinesia, as well as an array of non-motor symptoms that affect cognition, sleep, behaviour, and the autonomic nervous system.
Lifelong rehabilitation measures, along with medication treatment, are the major components of patient management. Physical exercises positively affect patients' quality of life (QOL) and their functional capacities. Poor adherence to rehabilitation, limited patient education, and access to specialized care can be barriers to treatment. A number of papers in fact report that telemedicine is an acceptable means of care delivery reduces travel burdens and may improve patient outcomes. However, most of these studies were not randomized or controlled and did not include nursing home patients, who may benefit the most from specialty care.
Moreover, there is no evidence supporting the use of telerehabilitation for physical assessments of people with PD. For this reason investigators hypothesize that a home telerehabilitation system guiding patients in following their exercise program combined with a computerized decision-support tool monitoring patient performance, would be feasible for and acceptable to patients with PD and would improve functional status.
详细描述
Aim of the study:
- Demonstrate the feasibility of at home telesurveillance and rehabilitation program
- Demonstrate the effectiveness of the program in improving quality of life and functional aspects in patients affected by Parkinson's disease
30 patients affected by Parkinson's disease (PD), will be consecutively screened. The method of sequence generation relied on a computerized random number generator. The person who allocated patients to the two groups was not involved either in treatment or in evaluation of the patients.
The study was submitted for approval of the Central Ethics Review Board. Participants will be randomly assigned to two different groups of training using a random number table to receive either telemedicine care (PTE) or their usual care (PUC).
All the patients will receive in our Institute a comprehensive baseline evaluation conducted by both the neurologist and the physical therapist specialized in the treatment of PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •30 patients affected by Parkinson's disease (PD), according to the United Kingdom Parkinson's Disease Society Brain Bank Criteria (Hughes et al.,1992), will be consecutively screened. Participants should have a Hoehn & Yahr stage between 1,5 and
- •All subjects will be on stabilized treatment with L-dopa or dopamine agonists.
- •All participants will provide written informed consent to the study.
排除标准
- •inability to participate in the exercise programs, other neurological conditions in addition to PD, psychiatric complications or personality disorders, musculoskeletal or cardiopulmonary conditions affecting mobility, and non-consent to participate in the study A cognitive impairment scores measured with Mini Mental State Examination (MMSE) ≤ 26/30.
结局指标
主要结局
Percentage of participants in the PTE group who will concluded the home-based program.
时间窗: Through study completion, an average of 3 months
The program is feasible if at least 80% of participants in the PTE group complete the home program lasting 3 months. The participant completes the home program if carries out at least 50% of the prescribed physical activity.
次要结局
- Improvement of quality of life (QoL) measured by the "Parkinson's disease questionnaire" (PDQ-39)(Difference between two groups of PDQ-39 measured at baseline (T0) and after 3 months (T1))
- Improvement of exercise tolerance capacity measured in the meters walked, by the 6-min walk test (6MWT)(Difference between two groups of 6MWT measured at baseline (T0) and after 3 months (T1))
- Improvement of balance measured by Balance Evaluation Systems Test (Mini BesTest)(Difference between two groups of Mini BesTest measured at baseline (T0) and after 3 months (T1))
研究者
Fabrizio Pisano
Head of Neurological Rehabilitation Division
Fondazione Salvatore Maugeri