SMART-PD: Evaluating the Impact of Smartphone-Based Wearable Technology on Motor Symptoms and Quality of Life in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Recruitment rate
研究概览
简要总结
This study aims to evaluate whether wearable technology can improve the management of motor symptoms in people with Parkinson's disease (PD) who experience motor fluctuations throughout the day. The project will use a smartwatch and mobile app (KinesiaU) to continuously track movement, allowing for more responsive and personalized treatment compared to traditional monitoring methods.
In this pilot randomized controlled trial, 32 participants will be assigned to either:
A control group receiving standard care, or
A wearable device group receiving standard care plus using the smartwatch.
Outcomes will be assessed over a 4-week period, focusing on changes in motor function, quality of life, and self-management. The study will also examine feasibility, adherence, and data quality.
If successful, this trial will provide critical evidence for integrating wearable devices into routine clinical care for PD, paving the way for larger efficacy trials and more patient-centered care strategies.
详细描述
Parkinson's disease (PD) is a common brain disorder that affects movement. It usually develops later in life and gradually worsens over time. People with Parkinson's may experience symptoms such as shaking (tremor), slow movement (bradykinesia), muscle stiffness, and problems with walking or balance. What makes Parkinson's especially challenging is that these symptoms can change throughout the day - a person may feel relatively well one moment and struggle to move just hours later.
Why is this a problem? This daily fluctuation in symptoms - known as motor fluctuations - makes it difficult for both patients and doctors to manage the disease. Traditional ways of monitoring symptoms, like keeping a diary or waiting until the next doctor's visit, don't always capture the full picture of what's happening. This can lead to treatment plans that don't match a person's actual needs.
What is the study about? We are exploring whether using wearable technology - in this case, a smartwatch and mobile app called KinesiaU - can help people with Parkinson's and their doctors better track and manage symptoms. The smartwatch measures movement throughout the day and sends data to a mobile app. This gives a more accurate and detailed view of how symptoms change over time, outside of the doctor's office.
Who is involved in the study?
The study will include 32 people living with Parkinson's disease who are experiencing motor fluctuations. They will be randomly divided into two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
video based assessment without knowledge of arm
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet criteria for Parkinson's disease using MDS Clinical Diagnostic Criteria for Parkinson's Disease
- •Presence of Motor fluctuations based on movement disorder neurologist assessment.
- •Motor ability to use the wearable device and access the wearable device application.
- •Cognitively ability to do ADL's and use the wearable device and access the wearable device application based on clinician's judgment.
- •Knowledge of English to enter medication details in the wearable device application.
排除标准
- •Physical barriers in using the wearable device.
- •Atypical Parkinsonian disorder or other causes of Parkinsonism
- •Inability to read or write English.
结局指标
主要结局
Recruitment rate
时间窗: Through study completion, an average of 1 year".
Recruitment rate, defined as the number of participants recruited divided by the number of participants eligible, multiplied by 100. This will indicate how effectively the study was able to enroll suitable participants.
Retention Rate
时间窗: Through study completion, around 1year
Retention rate calculated as the number of participants who complete the study divided by those recruited, and the dropout rate as the number of participan
Completion of Intervention:
时间窗: Through study completion, around 1year
The proportion of participants adhering to the full intervention will be calculated
次要结局
- MDS Unified Parkinson's Disease Rating Scale Part 3(4 weeks)
研究者
Deepa Dash
Assistant Professor
Western University