Study Results
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Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2017-04-22
2018-12-31
Brief Summary
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Detailed Description
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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.
Parkinson's Disease is the most common degenerative disorder of the central nervous system after Alzheimer's disease. Incidence rate for PD is about 18 per 100.000 person-years and it's one of the most important cause of motor disabilities in adult age with stroke.
Laboratory controlled research showed that stress response could changes psychophysiological parameters and signal (HR, GSR, EMG, EEG, etc...). A recent survey by Reinkensmeyer and colleagues (Reinkensmeyer et al., 2016) point out the relevance of computational approaches in neuro-rehabilitation which provide clear information about the neuromotor rehabilitation performance and its optimization thanks to feedback originate from analysis conducted on extensive motor and electrophysiological data.
With current technologies, many of which are available at a reduced cost, we are able to supervise on-line different aspects of our behavior, first of all the motor one. Equally important are all that technological supports which controls autonomic responses. Indeed, they highlight the relevance of individual internal response in context as the neuromotor rehabilitation one.
In such scenario, several questions still need a clear answer:
1. What are the triggering states to best cope with stressful situations and tasks?
2. What level of arousal is associated with the gradual increase of cognitive difficulties while carrying out a task?
3. Can the online feedback, on the patient's activation status, guide the work of the therapists and the patients themselves?
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.
1. Assess the psychophysical response;
1. Describe the configuration of physiological activation patterns.
2. Determine the interaction effect between task type and pathology.
2. Assess behavioral response;
1. Describe the performance,
2. Determine the interaction effect between task type and pathology.
3. Evaluate the subjective response.
a. Measure the degree of awareness of your state and your performance.
4. To highlight the relationships between psychophysiological patterns, behavioral performance and subjective response.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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 .
MS Band 2
Before starting the experiments, the subjects will be helped to wear the Microsoft® Band 2 bracelet (a smartwatch capable of recording data from over 12 sensors, including a heart rate sensor and a skin conductance sensor) and a session will be recorded Of 10 minutes at rest. After the rest period and always wearing the Microsoft® Band 2, the subjects will perform the other session of the procedure.
Emotion Assessment
The subjects will be subjected to the viewing of 21 video clips depicting 6 different emotional states belonging to the FilmStim database validated by Schaefer's studio and collaborators (Schaefer, Nils, Sanchez, \& Philippot, 2010). When viewing the clip, subjects will wear the Microsoft ® Band 2 .and after each movie clip of an evaluation of the stimulus value and activation level perceived by the Self-Assessment Manikin (Bradley \& Lang, 1994) questionnaire). The presentation of movie clip is randomized and does not follow a fixed effect. Between the presentation of each clip a fixed interval of 15 seconds has been inserted in order to induce artifacts and overlap of physiological signals among different emotional valence video clips.
Single Task
The section includes three tasks which involve upper and lower extremities, and cognitive functions, associated with low cognitive and motor load for their execution. Subjects are required to perform a single task, i.e. without the simultaneous execution of other tasks. Grasping(Motor Upper Limbs): The subject is required to reach an object's dominant limb and grab it. Walking(Motor Lower Limbs): It is required to carry 10 feet of walk. Attention(Cognitive): Signal detection task. The subject is required to detect acute sound between a series of serious sounds (Oddball Paradigm).
Dual Task
This section includes three tasks of different types (upper limb motor, lower limb motor, cognitive) that will be performed with a greater cognitive load. Elbow N-back (Dual Task Motor upper limbs): The subject is required to reconfigure the arrangement of the floppy disks on a different blade, by moving only one disk at a time and by putting a disk on another bigger disk, never on a smaller one. Walking + Nback (Dual Task Motor lower limbs): The subject is required to walk while subtracting from 100 to 3 in 3. Problem Solving (Dual Task Cognitive): The subject is subjected to a deductive logic puzzle.
Rest
At this stage, the HR and GSR signals will be recorded during a period of rest of 10 minutes. The subjects wear a pair of headphone for reducing the environmental sound noise. Through the headphones a sound indicates to the subject when recording starts and stops. Two separate recording of 5 minutes are performed, the first is performed while keeping eyes closed The two session are presented randomly to each different subject in order to prevent a bias due to order effect .
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 .
MS Band 2
Before starting the experiments, the subjects will be helped to wear the Microsoft® Band 2 bracelet (a smartwatch capable of recording data from over 12 sensors, including a heart rate sensor and a skin conductance sensor) and a session will be recorded Of 10 minutes at rest. After the rest period and always wearing the Microsoft® Band 2, the subjects will perform the other session of the procedure.
Emotion Assessment
The subjects will be subjected to the viewing of 21 video clips depicting 6 different emotional states belonging to the FilmStim database validated by Schaefer's studio and collaborators (Schaefer, Nils, Sanchez, \& Philippot, 2010). When viewing the clip, subjects will wear the Microsoft ® Band 2 .and after each movie clip of an evaluation of the stimulus value and activation level perceived by the Self-Assessment Manikin (Bradley \& Lang, 1994) questionnaire). The presentation of movie clip is randomized and does not follow a fixed effect. Between the presentation of each clip a fixed interval of 15 seconds has been inserted in order to induce artifacts and overlap of physiological signals among different emotional valence video clips.
Single Task
The section includes three tasks which involve upper and lower extremities, and cognitive functions, associated with low cognitive and motor load for their execution. Subjects are required to perform a single task, i.e. without the simultaneous execution of other tasks. Grasping(Motor Upper Limbs): The subject is required to reach an object's dominant limb and grab it. Walking(Motor Lower Limbs): It is required to carry 10 feet of walk. Attention(Cognitive): Signal detection task. The subject is required to detect acute sound between a series of serious sounds (Oddball Paradigm).
Dual Task
This section includes three tasks of different types (upper limb motor, lower limb motor, cognitive) that will be performed with a greater cognitive load. Elbow N-back (Dual Task Motor upper limbs): The subject is required to reconfigure the arrangement of the floppy disks on a different blade, by moving only one disk at a time and by putting a disk on another bigger disk, never on a smaller one. Walking + Nback (Dual Task Motor lower limbs): The subject is required to walk while subtracting from 100 to 3 in 3. Problem Solving (Dual Task Cognitive): The subject is subjected to a deductive logic puzzle.
Rest
At this stage, the HR and GSR signals will be recorded during a period of rest of 10 minutes. The subjects wear a pair of headphone for reducing the environmental sound noise. Through the headphones a sound indicates to the subject when recording starts and stops. Two separate recording of 5 minutes are performed, the first is performed while keeping eyes closed The two session are presented randomly to each different subject in order to prevent a bias due to order effect .
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 .
MS Band 2
Before starting the experiments, the subjects will be helped to wear the Microsoft® Band 2 bracelet (a smartwatch capable of recording data from over 12 sensors, including a heart rate sensor and a skin conductance sensor) and a session will be recorded Of 10 minutes at rest. After the rest period and always wearing the Microsoft® Band 2, the subjects will perform the other session of the procedure.
Emotion Assessment
The subjects will be subjected to the viewing of 21 video clips depicting 6 different emotional states belonging to the FilmStim database validated by Schaefer's studio and collaborators (Schaefer, Nils, Sanchez, \& Philippot, 2010). When viewing the clip, subjects will wear the Microsoft ® Band 2 .and after each movie clip of an evaluation of the stimulus value and activation level perceived by the Self-Assessment Manikin (Bradley \& Lang, 1994) questionnaire). The presentation of movie clip is randomized and does not follow a fixed effect. Between the presentation of each clip a fixed interval of 15 seconds has been inserted in order to induce artifacts and overlap of physiological signals among different emotional valence video clips.
Single Task
The section includes three tasks which involve upper and lower extremities, and cognitive functions, associated with low cognitive and motor load for their execution. Subjects are required to perform a single task, i.e. without the simultaneous execution of other tasks. Grasping(Motor Upper Limbs): The subject is required to reach an object's dominant limb and grab it. Walking(Motor Lower Limbs): It is required to carry 10 feet of walk. Attention(Cognitive): Signal detection task. The subject is required to detect acute sound between a series of serious sounds (Oddball Paradigm).
Dual Task
This section includes three tasks of different types (upper limb motor, lower limb motor, cognitive) that will be performed with a greater cognitive load. Elbow N-back (Dual Task Motor upper limbs): The subject is required to reconfigure the arrangement of the floppy disks on a different blade, by moving only one disk at a time and by putting a disk on another bigger disk, never on a smaller one. Walking + Nback (Dual Task Motor lower limbs): The subject is required to walk while subtracting from 100 to 3 in 3. Problem Solving (Dual Task Cognitive): The subject is subjected to a deductive logic puzzle.
Rest
At this stage, the HR and GSR signals will be recorded during a period of rest of 10 minutes. The subjects wear a pair of headphone for reducing the environmental sound noise. Through the headphones a sound indicates to the subject when recording starts and stops. Two separate recording of 5 minutes are performed, the first is performed while keeping eyes closed The two session are presented randomly to each different subject in order to prevent a bias due to order effect .
Interventions
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MS Band 2
Before starting the experiments, the subjects will be helped to wear the Microsoft® Band 2 bracelet (a smartwatch capable of recording data from over 12 sensors, including a heart rate sensor and a skin conductance sensor) and a session will be recorded Of 10 minutes at rest. After the rest period and always wearing the Microsoft® Band 2, the subjects will perform the other session of the procedure.
Emotion Assessment
The subjects will be subjected to the viewing of 21 video clips depicting 6 different emotional states belonging to the FilmStim database validated by Schaefer's studio and collaborators (Schaefer, Nils, Sanchez, \& Philippot, 2010). When viewing the clip, subjects will wear the Microsoft ® Band 2 .and after each movie clip of an evaluation of the stimulus value and activation level perceived by the Self-Assessment Manikin (Bradley \& Lang, 1994) questionnaire). The presentation of movie clip is randomized and does not follow a fixed effect. Between the presentation of each clip a fixed interval of 15 seconds has been inserted in order to induce artifacts and overlap of physiological signals among different emotional valence video clips.
Single Task
The section includes three tasks which involve upper and lower extremities, and cognitive functions, associated with low cognitive and motor load for their execution. Subjects are required to perform a single task, i.e. without the simultaneous execution of other tasks. Grasping(Motor Upper Limbs): The subject is required to reach an object's dominant limb and grab it. Walking(Motor Lower Limbs): It is required to carry 10 feet of walk. Attention(Cognitive): Signal detection task. The subject is required to detect acute sound between a series of serious sounds (Oddball Paradigm).
Dual Task
This section includes three tasks of different types (upper limb motor, lower limb motor, cognitive) that will be performed with a greater cognitive load. Elbow N-back (Dual Task Motor upper limbs): The subject is required to reconfigure the arrangement of the floppy disks on a different blade, by moving only one disk at a time and by putting a disk on another bigger disk, never on a smaller one. Walking + Nback (Dual Task Motor lower limbs): The subject is required to walk while subtracting from 100 to 3 in 3. Problem Solving (Dual Task Cognitive): The subject is subjected to a deductive logic puzzle.
Rest
At this stage, the HR and GSR signals will be recorded during a period of rest of 10 minutes. The subjects wear a pair of headphone for reducing the environmental sound noise. Through the headphones a sound indicates to the subject when recording starts and stops. Two separate recording of 5 minutes are performed, the first is performed while keeping eyes closed The two session are presented randomly to each different subject in order to prevent a bias due to order effect .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\- Ischemic attack diagnosis.
* Age between 25 and 80;
* Absence of neurologic disease;
Exclusion Criteria
* Inability to walk without aid (Hoen \& Yahr Scale \>3)
Stroke Group
* Mini Mental State Examination \< 24;
* Inability to walk without aid.
Healthy Subject Group
\- Mini Mental State Examination \< 24.
25 Years
ALL
Yes
Sponsors
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Università Politecnica delle Marche
OTHER
University of Padova
OTHER
IRCCS San Camillo, Venezia, Italy
OTHER
Responsible Party
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Patrizio Sale
Consultant Physician, Rehabilitation physician
Principal Investigators
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Patrizio Sale, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Camillo Hospital, University Of Padua
Locations
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Department of Neuroscience, University of Padua
Padua, , Italy
IRCCS San Camillo Hospital
Venezia, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Arent SM, Landers DM. Arousal, anxiety, and performance: a reexamination of the Inverted-U hypothesis. Res Q Exerc Sport. 2003 Dec;74(4):436-44. doi: 10.1080/02701367.2003.10609113.
Bradley MM, Lang PJ. Measuring emotion: the Self-Assessment Manikin and the Semantic Differential. J Behav Ther Exp Psychiatry. 1994 Mar;25(1):49-59. doi: 10.1016/0005-7916(94)90063-9.
DUFFY E. The psychological significance of the concept of arousal or activation. Psychol Rev. 1957 Sep;64(5):265-75. doi: 10.1037/h0048837. No abstract available.
Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.
Harrivel, A. R., Liles, C., Stephens, C. L., Ellis, K. K., Prinzel, L. J., & Pope, A. T. (2016). Psychophysiological Sensing and State Classification for Attention Management in Commercial Aviation. In AIAA Infotech @ Aerospace. Reston, Virginia: American Institute of Aeronautics and Astronautics. http://doi.org/10.2514/6.2016-1490
Kerr JH. The experience of arousal: a new basis for studying arousal effects in sport. J Sports Sci. 1985 Autumn;3(3):169-79. doi: 10.1080/02640418508729749.
Knaepen K, Marusic U, Crea S, Rodriguez Guerrero CD, Vitiello N, Pattyn N, Mairesse O, Lefeber D, Meeusen R. Psychophysiological response to cognitive workload during symmetrical, asymmetrical and dual-task walking. Hum Mov Sci. 2015 Apr;40:248-63. doi: 10.1016/j.humov.2015.01.001. Epub 2015 Jan 23.
Kuppens P, Tuerlinckx F, Russell JA, Barrett LF. The relation between valence and arousal in subjective experience. Psychol Bull. 2013 Jul;139(4):917-40. doi: 10.1037/a0030811. Epub 2012 Dec 10.
Kyle BN, McNeil DW. Autonomic arousal and experimentally induced pain: a critical review of the literature. Pain Res Manag. 2014 May-Jun;19(3):159-67. doi: 10.1155/2014/536859. Epub 2014 Feb 14.
Mackersie CL, Calderon-Moultrie N. Autonomic Nervous System Reactivity During Speech Repetition Tasks: Heart Rate Variability and Skin Conductance. Ear Hear. 2016 Jul-Aug;37 Suppl 1:118S-25S. doi: 10.1097/AUD.0000000000000305.
Reinkensmeyer DJ, Burdet E, Casadio M, Krakauer JW, Kwakkel G, Lang CE, Swinnen SP, Ward NS, Schweighofer N. Computational neurorehabilitation: modeling plasticity and learning to predict recovery. J Neuroeng Rehabil. 2016 Apr 30;13(1):42. doi: 10.1186/s12984-016-0148-3.
Salehi B, Cordero MI, Sandi C. Learning under stress: the inverted-U-shape function revisited. Learn Mem. 2010 Sep 30;17(10):522-30. doi: 10.1101/lm.1914110. Print 2010 Oct.
Schaefer, A., Nils, F. F., Sanchez, X., & Philippot, P. (2010). Assessing the effectiveness of a large database of emotion-eliciting films: A new tool for emotion researchers. Cognition & Emotion, 24(7), 1153-1172. http://doi.org/10.1080/02699930903274322
Shelgikar AV, Anderson PF, Stephens MR. Sleep Tracking, Wearable Technology, and Opportunities for Research and Clinical Care. Chest. 2016 Sep;150(3):732-43. doi: 10.1016/j.chest.2016.04.016. Epub 2016 Apr 29.
Westman, M., & Eden, D. (1996). The inverted-U relationship between stress and performance: A field study. Work & Stress, 10(2), 165-173. http://doi.org/10.1080/02678379608256795
Wiberg H, Nilsson E, Linden P, Svanberg B, Poom L. Physiological responses related to moderate mental load during car driving in field conditions. Biol Psychol. 2015 May;108:115-25. doi: 10.1016/j.biopsycho.2015.03.017. Epub 2015 Apr 6.
Other Identifiers
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2016.25
Identifier Type: -
Identifier Source: org_study_id
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