Feasibility and Efficacy of a Home Exercise Program Using mHealth Technology in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Step Length of gait at preferred pace
研究概览
简要总结
The main objective of the study is to explore the feasibility and effectiveness of this type of mHalth technology in the treatment of motor symptoms in people with Parkinson's disease.
详细描述
Parkinson's disease (PD) is a neurological disease whose motor symptoms drastically affect the quality of life of those who suffer from it. There is currently high scientific evidence of the positive effect of physical exercise on the motor function of people with PD. This effect seems to be more relevant when this physical exercise is implemented with external sensory signals (eg visual, auditory). However, the health and socioeconomic context of the patient conditions their access to treatments and physical exercise programs, associationism being common as a low-cost strategy to cover the different therapies. The development of telemedicine, electronic devices and mobile health applications could be an interesting option for those patients who find themselves in the situations mentioned above. However, there are several limitations regarding the use of mobile health apps, such as that less than
1% of them are grounded in research evidence and the digital barrier. Therefore, the main objective of the study is to explore the feasibility and effectiveness of this type of mHalth technology in the treatment of motor symptoms in people with Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Absence of treatment with psychotropic drugs or stable dose of the same (without drug or dose modifications in the last four weeks).
- •In the case of subjects who are part of the intervention group, the following will also be inclusion criteria:
- •Caregiver or family member who presents the appropriate skills for collaboration in the implementation of the exercises and in the management of the mobile application.
- •Availability of the necessary time for the initial training in the handling of the devices, the development of the sessions and the communication with the researchers.
排除标准
- •Insufficient physical condition for participation.
- •Sensory deficits that make participation difficult.
- •Unstable clinical situation.
- •Unstable mental disorder or not adequately controlled with medication (depression, agitation, etc.).
- •Presence of associated pathology that involves treatment with drugs that alter cognitive abilities or interfere with the user's participation
结局指标
主要结局
Step Length of gait at preferred pace
时间窗: At week 8
Step Length (m)
Speed of gait at preferred pace
时间窗: at week 8
Speed (m/s)
Cadence of gait at preferred pace
时间窗: At week 8
cadence (steps/min)
次要结局
- Time up & go test(At week 8)
研究者
Miguel Fernández del Olmo
Proffessor
Universidad Rey Juan Carlos