Use of Balance Detection Devices for Elderly People Under the Influence of Stress (DEPIE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pressures on the floor
研究概览
简要总结
The aging process involves physiological changes in organs and tissues that can evolve towards fragility and increased risk of falls. Falls, which can be one of the adverse results of frailty in older people, are the second leading cause of death worldwide. When an elderly person falls, it entails not only hospitalization, immobilization, and the consequent deterioration, but also usually causes fear of falling again, which can also lead to the onset of disability. The inherent aging process can be linked to the deterioration of postural control and balance, posing serious health problems. In falls in the elderly, both sensorimotor and cognitive functions are affected, the functioning of which is degraded to a greater extent by anxiety and stress. Nowadays, more extensive, and more precise research is needed in the study of the interactions between cognition, stress, and postural control in the context of postural instability and falls in older adults.
The purpose of the DEPIE Project is to detect whether neuromuscular changes that occur when exposed to stressful situations can affect the postural and motor control of the elderly.
To this end, all participants will undergo the same intervention. Firstly, they will all take a baseline cognitive and physical assessment. Afterwards, they will take the experimental session, which will consist of a baseline test and an experimental test. During the baseline test, participants will visualize International Affective Picture System (IAPS) images of low arousal and during the experimental test of high arousal. Finally, physical assessment tests will be repeated.
Young and older adults will be tested. Additionally, sub-analyses will be conducted within the elderly group differentiating the degree of cognitive impairment and functional dependence.
The primary outcome measures will be surface electromyography, pressures on the floor, activity on manipulation, and balance.
The secondary outcome measures will be heart rate variability, respiratory rate and the visual analogue scale on unease after visualisation of the images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
Although all participants will perform the same intervention, they will not know which intervention the other participants are performing. In addition, the entire experimental session (both baseline and experimental test) is computerized, so the researcher in charge of the experiment will only ensure that all systems are working properly. On the other hand, the outcome evaluator will analyze the baseline and experimental moments without knowing whether the data belong to one or the other moment.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young adults (ages 18-39).
- •Older adults (≥65).
- •Voluntarily participate in the study.
- •Not meeting the
排除标准
- •Exclusion Criteria:
- •Any disease, injury, or previous trauma that contraindicates muscular exertion, balance exercises, and/or walking.
- •Any physical or mental illness that contraindicates exposure to stimuli generating emotional stress, such as severe depression or severe psychosis
- •Difficulties in understanding study information and providing informed consent
结局指标
主要结局
Pressures on the floor
时间窗: It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test
They will be measured by a sensorised blanket that will give information on weight distribution and movement behaviour
Triaxial accelerometry: acceleration and deceleration in object handling
时间窗: It will be assessed while performing the bottle manipulation movement (during which liquid has to be transferred from one bottle to another), both during the baseline test and during the experimental test
The maximum acceleration value during the handling activity of two bottles shall be measured with sensors installed on the bottles.
RMS value of the EMG signal
时间窗: It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test
The root mean square (RMS) value of the EMG signal reflects the level of muscle activation during activity.
EMG: Synchronisation of activation between muscle groups
时间窗: It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test
It will assess in milliseconds the ability of the muscles to work in a synchronised manner.
EMG: Activation ratio between upper and lower body muscles
时间窗: It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test
RMS ratio between different muscles
EMG: Median Frequency (MDF)
时间窗: It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test
In the frequency domain, this median frequency of the EMG signal will be calculated.
Balance
时间窗: Before the baseline test and after the experimental test
It will be assessed by Timed Up and Go Test (TUG) and Functional Reach Test (FRT)
次要结局
- Heart Rate Variability(It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test)
- Respiratory Rate(It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test)
- Analog Visual Scale(Immediately after the baseline test and the experimental test respectively)
研究者
Susana Nunez Nagy
PhD. Associate Professor.
University of Alcala