Handwriting as an Objective Tool to Support the Identification of People With Alzheimer's Disease: Suitability of an Assessment Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Vertical/horizontal size
研究概览
简要总结
Alzheimer's disease (AD) is the most common of dementia, and has associated cognitive and motor disorders, with consequences on daily activities, including handwriting.
Handwriting has been used to study fine motor control or executive functioning in healthy and unhealthy populations. Changes in this skill are present at different stages of the clinical course of Alzheimer's Disease. The sensorimotor deterioration is observed in handwriting tasks (motion kinematics, such as movement time, speed, and profiles) and brain activity rhythms.
Handwriting has been used to study fine motor control or executive functioning in healthy and unhealthy populations, and changes in this skill are present at different stages of the clinical course of dementia. From a theoretical perspective, because sensorimotor deterioration observed in handwriting tasks (motion kinematics, such as movement time, speed, and profiles).
Due to the large number of brain areas related to handwriting performance, brain electrical activity analysis can be an early indicator of brain dysfunction. Although there is a lack of validation across healthy and non-healthy populations Electroencephalogram (EEG) measures have the potential for evaluating cognitive performance.
This research aims to analyze the suitability of the handwriting assessment protocol, which can contribute to a more in-depth knowledge of this subject and potentially support early identification and treatment.
详细描述
The minimum sample size for this pilot study is 75 participants, which is the minimum sample size calculated by G*power (90% power, significance level 0.05) to perform the planned between-group comparisons (ANOVA), correlations (Pearson), and nonlinear analyses. Participants who agree to participate in this study will be asked to provide demographic information, such as age, Portuguese as a native language, education level, motor/physical problems, and medical problems. By underlining the social relevance of the project, the investigators anticipate that at least 80% of the invited subjects will be interested in participating in this research.
In the first phase, the request for analysis of this project by the Ethics Committee and the Scientific Council of the University of Évora was made. After approval, the entities were contacted to present the project and start contact with the participants. Then, each participant (or their legal tutor) gave informed consent, where they were aware of the confidentiality of the data collected throughout the study and that they would not be disclosed, being only used for academic purposes.
Subjects were invited to participate in three organizations: Espírito Santo Hospital of Évora (HESE) and two Residential Centers for the Elderly. Two types of participants were recruited in these organizations. At HESE, participants with a diagnosis of dementia (validated by the medical team of the Neurology Service) and some of their healthy family members (without a diagnosis). At the Residential Centre for the Elderly, participants who did not have any medical diagnosis record were subject to a neuropsychological evaluation (lasting approximately 60 minutes) to differentiate the group of participants with and without dementia (and not to define which type of dementia). All participants will take a handwriting assessment (lasting approximately 60 minutes).
The data will be analyzed using the Statistical Package for the Social Sciences [SPSS] to conduct a cross-sectional study.
For the neuropsychological assessment, the following instruments will be used:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Vertical/horizontal size
时间窗: Baseline
Vertical vector difference between the start and end of a stroke (in cm).
Brain activity
时间窗: Baseline
Spectral density mean from the frequency of the three bands (theta, alpha, beta)
Stroke
时间窗: Baseline
A stroke is a series of lines or curves written in a single letter, i.e., the path traced by the pen on the paper. Traces are analyzed movements that unite a movement pattern. A movement pattern can be segmented using 2 segmentation methods: zero crossings of the velocity profile after the velocity peak or the minimum velocity after the velocity peak. This measure is obtained through the software Movalyzer, during the handwriting tasks.
Slant
时间窗: Baseline
Segment slope, which is estimated by the orientation of the line by minimizing/reducing the sum of the squares of the perpendicular distances of all pixels to the line through the gravity point (in radians).
Duration
时间窗: Baseline
Time interval between the first and last samples in a stroke/segment (in sec).
Vertical/horizontal start position
时间窗: Baseline
Initial vertical/horizontal position relative to the lower limit of the digitizer area (in cm).
Pen pressure
时间窗: Baseline
Average pen pressure values along a stroke (N/m2).
Reaction time
时间窗: Baseline
Is the time from the start of the recording to the start of the trace (in sec).
次要结局
- Handwriting legibility(Baseline)
- Handwriting speed(Baseline)
- Visuomotor integration(Baseline)
研究者
Ana Rita Matias
Researcher and Assistant Professor
University of Évora