Arousal Response Tool for Neurological Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Galvanic Skin Response
研究概览
简要总结
The present study therefore aims at studying and evaluating the state of activation by psycho-physiological, behavioral, and subjective responses of individuals with Stroke and Parkinson's disease in contexts from the gradual increase in cognitive and stress loads, in order to provide information on the possibility Use of biofeedback devices in rehabilitation contexts.Objectives: assess the psychophysical response; to describe the configuration of physiological activation patterns; to determine the interaction effect between task type and pathology; to assess behavioral response;to describe the performance; to determine the interaction effect between task type and pathology; to evaluate the subjective response; to measure the degree of awareness of your state and your performance.
详细描述
The context and the environment in which we act may interact significantly with our actions and with the property of our performance, leads to alterations of arousal states and psychophysiological stress responses.
Stress has typically been defined as a state that occurs when situation's demands are inconsistent with social, psychological and biological person's resources. Stress is an adaptive response direct to optimize the available resources to cope a given situation. However, when resources demand outstrips the individual's ability, stress has negative effects (distress). Stress effects are investigated along three domains: (1) at biological and neurophysiological modifications level, (2) at behavioral performance level and finally (3) through the subjective assessment (self-report questionnaire).
Many psychological theories have taken into account the Inverted-U shape model, in which arousal and performance are mutually reliant. There is an optimal level of arousal at which performance peaks whereas, at both lower or higher level than the optimal one, performance deteriorates .
Other thesis instead explain the different responses to stress and performance modifications in terms of cognitive resources, in particular the attentive and executive ones. Therefore, the measurement of stress involves the analysis of particular bio signals which are tied tightly to arousal such as Heart Rate (HR), Galvanic Skin Response (GSR) and electromyography (EMG), to which we should add behavioral assessment, cognitive load (in a range from single task to multi-tasking execution) and subjective assessment of one's own state of stress/distress.
Motor disability caused by neurological disorder is an important issue: every years 16 millions of people all over the world are affected by stroke and currently 33 million stroke survivor are affected by a serious acquired motor disability. Almost the whole of them are subjected to serious limitations of daily living activities and require constant assistance to their relatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parkinson's disease Group
- •Inclusion criteria:
- •Diagnosis of idiopathic Parkinson's Disease according to the UK Brain Bank Criteria
排除标准
- •Mini Mental State Examination < 24;
- •Inability to walk without aid (Hoen & Yahr Scale >3)
- •Stroke Group
- •Inclusion criteria:
- •Ischemic attack diagnosis.
- •Exclusion criteria:
- •Mini Mental State Examination < 24;
- •Inability to walk without aid.
- •Healthy Subject Group
- •Inclusion criteria:
- •Age between 25 and 80;
- •Absence of neurologic disease;
- •Exclusion criteria:
- •Mini Mental State Examination < 24.
研究组 & 干预措施
Parkinson's disease Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: Emotion Assessment (Behavioral)
Parkinson's disease Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: Single Task (Behavioral)
Parkinson's disease Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: Dual Task (Behavioral)
Parkinson's disease Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: MS Band 2 (Device)
Parkinson's disease Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: Rest (Behavioral)
Stroke Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: MS Band 2 (Device)
Stroke Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: Emotion Assessment (Behavioral)
Stroke Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: Single Task (Behavioral)
Stroke Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: Dual Task (Behavioral)
Stroke Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: Rest (Behavioral)
Healthy Subjects Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: MS Band 2 (Device)
Healthy Subjects Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: Emotion Assessment (Behavioral)
Healthy Subjects Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: Single Task (Behavioral)
Healthy Subjects Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: Dual Task (Behavioral)
Healthy Subjects Group
The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.
All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .
干预措施: Rest (Behavioral)
结局指标
主要结局
Galvanic Skin Response
时间窗: 3 hours
The GSR sensor measures the conductivity of the skin between the GSR diode contact points on the other side of the clasp, raised from the battery cover. Galvanic Skin Response data are acquired and stored in a connected device text file using a customised application able to acquire MS Band 2 GSR signal at a sample rate of 40 Hz, and expressed in microsiemens (µS).
Heart Rate
时间窗: 3 hours
The optical heart rate monitor of the Microsoft Band uses a light sensor to detect minor fluctuations in the wrist capillaries. The heart rate monitor is located on the back of the clasp. Heart Rate data are continuously acquired and stored in a connected device text file using a customised application able to acquire MS Band 2 HR signal at a sample rate of 2 Hz, together with a timestamp, and expressed in heart beats per minutes (bpm).
Valence
时间窗: 3 hours
Valence is measured using the Self-Assessment Manikin (SAM) (Hodes, Cook \& Lang, 1985) to directly assess the valence, arousal, and dominance associated in response to an object or event. SAM Valence is a self assessment 7-point likert scale which ranges from a smiling, happy figure (score: 7) to a frowning, unhappy figure (score: 1) when representing the pleasure dimension. The scale is proposed after each stimuli is presented or task executed by the subjects, and the scores are collected through the psychology experiment design software Psychopy (Peirce, 2007), which collects also the subjects ID and the timestamp, while the band is worn by the subjects.
Arousal
时间窗: 3 hours
Arousal is measured using the Self-Assessment Manikin (SAM) (Hodes, Cook \& Lang, 1985) to directly assess the valence, arousal, and dominance associated in response to an object or event. SAM Arousal is a self assessment 7-point likert scale which ranges from an excited, wide-eyed figure (score: 7) to a relaxed, sleepy figure (score: 1) for the arousal dimension. The scale is proposed after each stimuli is presented or task executed by the subjects, and the scores are collected through the psychology experiment design software Psychopy (Peirce, 2007), which collects also the subjects ID and the timestamp, while the band is worn by the subjects.
次要结局
未报告次要终点
研究者
Patrizio Sale
Consultant Physician, Rehabilitation physician
IRCCS San Camillo, Venezia, Italy