Cerebral PalsyNCT05621057
Evaluation Methodology of Emotional States for People With Cerebral Palsy
An observational study of Cerebral Palsy and Physically Challenged, run by University of Seville at 1 site in Spain.
Trial summary
The objective of this study is to determine what are the most robust parameters for the measurement of emotional states in users suffering from cerebral palsy. Users have different ages (adults and children) with different capacities. Read more about this study
- Who is it for?
- Ages 5 to 55 years
- Conditions the study is for
- Cerebral Palsy, Physically Challenged, Emotional Adjustment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 3 Feb 2025
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The population who took part in this study attend two different centers for people with special needs: Asociación Sevillana de Parálisis Cerebral (ASPACE) and Centro Específico de Educación Especial Mercedes Sanromá (CEEEMS). ASPACE is a private organization catering mainly for adults with CP. The other center, CEEEMS, is a public specialist school that forms part of the educational network in Andalusia (Spain) and deals mainly with children and teenagers with motor dysfunctions (including CP).
Who may be able to join
- 1.People with a recognized disability, caused by a permanent illness or health situation.
Who cannot join
- Present any health situation that is incompatible with the use of assistive technology designed and prototype in the project.
- Have a very limited cognitive ability, which prevents you from following the instructions for the proper use of assistive technology.
- Not having adequate human support.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Augmentative Affective Interface (AAI): Evaluation Methodology of Emotional States for People With Cerebral Palsy
The objective of this study is to determine what are the most robust parameters for the measurement of emotional states in users suffering from cerebral palsy. Users have different ages (adults and children) with different capacities. Measures will be taken in different contexts where users will do several tasks pleasant and unpleasant. Some of the tasks involve physical activity, which must be taken into account due to the possible disturbance that it can introduce in the measures taken.
It is intended to detect states of demotivation, fatigue, or physical or emotional stress. For this, we will use signals of two types: physiological measurements and inertial sensors. The handicap we find is that the subjects have difficulties expressing and recognizing emotional states, which rules out the use of a self-assessment test to contrast the measures taken. This makes us turn to their caregivers or family members or alternatively or in a complementary way to take measurements in contexts or situations of daily life where the emotional state induced in the subject is known.
Read more
Once the parameters were established, the measurement of the emotional state will allow us to make a real-time evaluation of how the users are feeling during the tasks, in this way the activity can be better conducted by adapting it so that it is as efficient as possible and takes us to good results.
Music will be studied as a motivating factor and for improving the emotional state when approaching rehabilitation therapies.
There will be 4 sessions during which measurements will be recorded.
1: measurement of this parameter when he or she is in an activity of daily life that is pleasurable. 2: measurement of this parameter when he or she is in an activity of daily life that is of discomfort. 3: Measurement of this parameter during the performance of rehabilitation activities. 4: Measurement of this parameter during rehabilitation activities accompanied with music according to the preferences.
Read the detailed description
CONTEXT AND MEASUREMENT FREQUENCIES
Four sessions will be held, divided into two parts:
PART 1: Selection of dependent variables. The aim of the first two sessions is to be able to count a reference level for physiological variables in activities that provoke pleasant and unpleasant emotions, so that they can be used as a reference in Part 2; the purpose is to try to avoid dependence on the EVEA tests since the subjects will not always be able to express their emotions. The EVEA test is used as a reinforcer for a possible automatic classifier.
- Session 1: measurement of parameters to the subject when he or she is in an activity of daily life that is pleasurable for him or her in the center. This session will be determined by conversation with the caregiver since it is particular for each subject.
- Session 2: measurement of parameters to the subject when he or she is in an activity of daily life that is of discomfort for him or her in the center. This session will be determined by conversation with the caregiver since it is particular for each subject.
Half of the participants will start with session 2 and then do session 1, while the rest will follow the reverse order.
PART 2. Effect of music on the dependent variables during the performance of rehabilitation exercises
- Session 3: Measurement of parameters to the subject during the performance of rehabilitation activities in the center.
- Session 4: Measurement of parameters to the subject during rehabilitation activities in the center. The session will be accompanied with music according to the preferences of the subject.
The pleasant motivational music to be played during session 4 will be selected by each user according to his or her musical preferences, or, failing that, will be transmitted to us by his or her caregiver. The rehabilitation activity should be a light exercise for the user, such as pedaling, limb extension, or any other that is measurable through inertial units. The specific activity that each user will have to perform will be determined by the medical staff and/or physiotherapist of each center, as it will be limited by the movement capacity of each participant.
Although each session has a different theme, the structure of the sessions is similar. First, the sensors are placed on the volunteer; once it has been verified that the data are collected in an adequate manner, the data recording begins while the user is answering the EVEA test. This first part of the recording will be used as a baseline for the session, which should last at least two minutes. After that, the activity will start, which will not last more than 15 minutes; and to finish, a new EVEA test will be filled in, with identical restrictions to the first test. With these initial and final baselines, the differential of the measurements of each session can be detected, in addition to the analysis of the evolution of the subject during the activity.
For each user, the protocol should be completed in two weeks, during the first week sessions 1 and 2, and during the second week sessions 3 and 4.
- Conditions
- Cerebral Palsy, Physically Challenged, Emotional Adjustment
- Keywords
- emotional measure, image processing, physiological parameters
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Average kinetic energy measurements (in joules) using inertial sensors
Four wearable devices in wrist, ankle, chest and head are used. All have inertial units. They provide information in the different contexts (scheduled sessions) about the energy expenditure that these entail. It should be studied whether this parameter is related to the emotional state.
Measured: Fifteen minutes.
Instantaneous Heart Rate (in seconds)
We used a wearable placed in the chest with Ag/AgCl electrodes for ECG, placed following the Einthoven's II lead positions. The position of R wave is determined using an appropriate algorithm and then time difference between two consecutive R waves is calculated, this time difference is used to calculed HR.
We used 30s-length sliding windows with an overlap of 50%. The instantaneous HR is given by the average HR in such a window after removing the outliers.
Measured: Fifteen minutes.
The ratio between low frequency, (LF) and high frequency, (HF), (LF/HF)
We used a wearable placed in the chest with Ag/AgCl electrodes for Electrocardiogram (ECG) ,placed following the Einthoven's II lead positions. The ratio between low frequency , [0.04 - 0.15] Hz (LF) and high frequency, [0.15 - 4] Hz (HF) components of HRV, (LF/HF), shows the balance between the SNS (Sympathetic Nervous System) and the PNS (Parasympathetic Nervous System).
Measured: Fifteen minutes.
Temporal parameters of Heart Rate Variability (HRV)
We used a wearable placed in the chest with Ag/AgCl electrodes for Electrocardiogram (ECG) ,placed following the Einthoven's II lead positions. The HRV is especially interesting because it allows to assess the activity of the parasympathetic and sympathetic pathways of the ANS (Autonomic Nervous System). HVR can be measured using temporal parameters such as: SDNN Standard deviation of NN intervals; RMSSD Root mean square of successive differences between normal heartbeats; pNN50 Percentage of successive RR intervals that differ by more than 50 ms.
Measured: Fifteen minutes.
Tonic Skin Conductance Level (SCL)
This signal is the background tonic of the Electrodermal Activity signal (EDA). It will be measured by dry electrodes that were placed on the hearten and hypothenar eminences of the dominant hand.
Measured: Fifteen minutes.
Parameters of Phasic Skin Conductance Response (SCR)
It will be measured by dry electrodes that were placed on the hearten and hypothenar eminences of the dominant hand This signal are constituted by the rapid phase components of the Electrodermal Activity signal (EDA). An SCR that cannot be attributed to a distinct stimulus is referred to as non-specific skin conductance response (NS-SCR). This category includes the spontaneous fluctuations in skin conductance that are our case because we measured the signal in periods without stimulus.
Measured: Fifteen minutes.
Fractal dimension of Electroencephalogram signal (EEG)
The EEG portrays the functioning of the brain. the recording of those signals will be done at a sampling rate of 125 Hz by OpenBCI. OpenBCI (https://openbci.com/) is a low-cost open-hardware device for the measure of EEG signals using 16 channels in positions FP1, FP2, F1, F2, F5, F6, Cz, C3, C4, T7, T8, Pz, P3, P4, O1, O2.
The EEG signals are highly complex and dynamic in nature. Fractal dimension (FD) is emerging as a novel feature for computing its complexity. We will use the Higuchi's algorithm.
Measured: Fifteen minutes.
Spectral Entropy (SE) of EEG signal
The EEG portrays the functioning of the brain. the recording of those signals will be done at a sampling rate of 125 Hz by OpenBCI.
SE can be used for computing EEG complexity. To do that, the power spectral density (PSD) must be obtained as a first step . After normalizing the PSD by the number of bins, which can be viewed as a probability density function conversion, the classical Shannon's entropy for information systems is then calculated.
Measured: Fifteen minutes.
EEG coherence
The interactions between neural systems, operating in each frequency band, are estimated by means of the EEG coherence. While neural synchronization influences EEG amplitude, the coherence between signals captured by one pair of electrodes refers to the consistence and stability of the signal amplitude and its phase. Two brain areas connected should show a signal delay in time domain that is measured as a phase shift in the frequency domain.
Measured: Fifteen minutes.
Activity of the regions in the brain
We will use Loreta. Loreta is a specific solution to the inverse problem, using algorithms that localize the cortical generators of the observed neuronal firing.
Measured: Fifteen minutes.
Secondary outcomes (6)
International Classification of Functioning, Disability and Health (ICF)
The ICF is a "universal framework for the definition, measurement and policy formulations for health and disability", developed by the WHO and used in health-related sectors.This scale is used to measure several domains in adults: functional ability, cognitive and communication capacities and the quality of life related to health.
It is graduated from 0 (no) to 4 (complete).
Measured: Through study completion, an average of 2 weeks.
Gross Motor Function Classification System (GMFCS)
The GMFCS is a five-level scale focused on truncal control and walking. The discrimination at each level of motor function is based on functional limitation and the use (or not) of assistive devices such as walkers, wheelchairs, etc.
The scale goes from I: the ability to ambulate to V: dependent on AT for all mobility.
Measured: Through study completion, an average of 2 weeks.
Manual Ability Classification System (MACS)
The MACS scale assesses how children use both hands in situations of their daily life and whether they are independent or need some support. The opinion of people who know them and the age of the children are taken into account for this scale.
The scale goes from I: Handles objects easily and successfully; V: Does not manipulate objects. Limited ability to perform simple actions.
Measured: Through study completion, an average of 2 weeks.
Communication Function Classification System (CFCS)
This scale is used to measure communication ability in children. The CFCS scale is a classification system for functional communication divided into five levels to identify performance in everyday communication.
The scale goes from I: Efficient sender and receiver with known and unknown interlocutors; V: Sender and receiver rarely effective even with known interlocutors.
Measured: Through study completion, an average of 2 weeks.
KIDSCREEN Questionnaire
The KIDSCREEN instruments assess children's and adolescents' subjective health and well-being. They were developed as self-report measures applicable for healthy and chronically ill children and adolescents aged from 8 to 18 years.
Measured: Through study completion, an average of 2 weeks.
SCALE FOR MOOD ASSESSMENT (EVEA)
The EVEA was developed as an instrument "to measure transitory moods in studies using mood induction procedures", but it can be used whenever there is a need to measure transitory moods at any one time. The EVEA is composed of 16 items. Each item has an 11-point Likert scale (from 0 to 10), flanked by the words "not at all" (0) and "very much" (10), that presents, in its left margin, a short statement describing a mood. All 16 statements have the same structure; all of them begin with the expression "I feel" and end with an adjective describing a mood (e.g., "I feel sad", "I feel happy"). The EVEA tries to assess four moods; anxiety, anger-hostility, sadness-depression, and happiness. Each mood is measured by four items with different adjectives, and these four items define a subscale. All items of a given subscale are worded in the same direction.
Measured: Through study completion, an average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Nov 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion3 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Gómez González, University of Seville
- Investigators
- Isabel M. Gomez-Gonzalez, Phd, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621057
- Sponsor's protocol ID
- 2022_D6
- Status last verified
- Sep 2024
- First submitted
- 12 Oct 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
R. Martinez; A. Salazar-Ramirez; A. Arruti; E. Irigoyen; J. I. Martin; J. Muguerza. A Self-Paced Relaxation Response Detection System Based on Galvanic Skin Response Analysis. 2019. IEEE Access PP(99):1-1
Can Y.S., Chalabianloo N., Ekiz D., Fernandez-Alvarez J., Repetto C., Riva G., Iles-Smith H., Ersoy C. Real-Life Stress Level Monitoring Using Smart Bands in the Light of Contextual Information. IEEE Sensors Journal. 2020.
Rincon JA, Costa A, Novais P, Julian V, Carrascosa C. ME3CA: A Cognitive Assistant for Physical Exercises that Monitors Emotions and the Environment. Sensors (Basel). 2020 Feb 5;20(3):852. doi: 10.3390/s20030852.
PubMed 32033498Correa, J.A.M.; Abadi, M.K.; Sebe, N.; Patras, I. Amigos: a dataset for affect, personality and mood research on individuals and groups. IEEE Trans. Affect. Comput. 2018.
Price E., Moore G., Galway L., Linden M. Towards mobile cognitive fatigue assessment as indicated by physical, social, environmental, and emotional factors. IEEE Access. 2019.
Qureshi S., Hagelbäck J., Iqbal S.M.Z., Javaid H., Lindley C.A. Evaluation of classifiers for emotion detection while performing physical and visual tasks: Tower of Hanoi and IAPS. Intelligent Systems Conference 2018.
Belmonte S, Montoya P, Gonzalez-Roldan AM, Riquelme I. Reduced brain processing of affective pictures in children with cerebral palsy. Res Dev Disabil. 2019 Nov;94:103457. doi: 10.1016/j.ridd.2019.103457. Epub 2019 Sep 11.
PubMed 31520963Albiol-Pérez S., Cano S., Da Silva M.G., Gutierrez E.G., Collazos C.A., Lombano J.L., Estellés E., Ruiz M.A. A novel approach in virtual rehabilitation for children with cerebral palsy: Evaluation of an emotion detection system. Advances in Intelligent Systems and Computing. 2018.
C. Rosales; L. Jácome; J. Carrión; C. Jaramillo; M. Palma. Computer vision for detection of body expressions of children with cerebral palsy.2017 IEEE Second Ecuador Technical Chapters Meeting (ETCM).
Kalansooriya P., Ganepola G.A.D,Thalagala T.S. Affective gaming in real-time emotion detection and Smart Computing music emotion recognition: Implementation approach with electroencephalogram. Proceedings - International Research Conference on Smart Computing and Systems Engineering, SCSE 2020.
Molina Cantero, Alberto Jesus, Gómez González, Isabel María, Merino Monge, Manuel, Castro García, Juan Antonio, Cabrera Cabrera, Rafael: Emotions detection based on a single-electrode EEG device. Comunicación en congreso. 4 ª International Conference on Physiological Computing Systems. - Madrid,. 2017
Merino M, Gomez I, Molina AJ. EEG feature variations under stress situations. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:6700-3. doi: 10.1109/EMBC.2015.7319930.
PubMed 26737830Merino Monge, Manuel, Gómez González, Isabel María, Castro García, Juan Antonio, Molina Cantero, Alberto Jesus, Quesada, Roylan: A Preliminary Study about the Music Influence on EEG and ECG Signals. Comunicación en congreso. 5th International Conference on Physiological Computing Systems. Sevilla. 2018
Castro García, Juan Antonio, Molina Cantero, Alberto Jesus, Merino Monge, Manuel, Gómez González, Isabel María: An Open-Source Hardware Acquisition Platform for Physiological Measurements. En: IEEE Sensors Journal. 2019. Vol. 19. 10.1109/Jsen.2019.2933917
Gomez-Gonzalez IM, Castro-Garcia JA, Merino-Monge M, Sanchez-Anton G, Hamidi F, Mendoza-Sagrera A, Molina-Cantero AJ. Emotional State Measurement Trial (EMOPROEXE): A Protocol for Promoting Exercise in Adults and Children with Cerebral Palsy. J Pers Med. 2024 May 14;14(5):521. doi: 10.3390/jpm14050521.
PubMed 38793103
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentative Affective Interface (AAI): Evaluation Methodology of Emotional States for People With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05621057
- Acronym / sponsor ID
- 2022_D6
- Conditions
- Cerebral Palsy, Physically Challenged, Emotional Adjustment
- Keywords
- emotional measure, image processing, physiological parameters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 3 Feb 2025 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine what are the most robust parameters for the measurement of emotional states in users suffering from cerebral palsy. Users have different ages (adults and children) with different capacities. Measures will be taken in different contexts where users will do several tasks pleasant and unpleasant. Some of the tasks involve physical activity, which must be taken into account due to the possible disturbance that it can introduce in the measures taken.
It is intended to detect states of demotivation, fatigue, or physical or emotional stress. For this, we will use signals of two types: physiological measurements and inertial sensors. The handicap we find is that the subjects have difficulties expressing and recognizing emotional states, which rules out the use of a self-assessment test to contrast the measures taken. This makes us turn to their caregivers or family members or alternatively or in a complementary way to take measurements in contexts or situations of daily life where the emotional state induced in the subject is known.
Once the parameters were established, the measurement of the emotional state will allow us to make a real-time evaluation of how the users are feeling during the tasks, in this way the activity can be better conducted by adapting it so that it is as efficient as possible and takes us to good results.
Music will be studied as a motivating factor and for improving the emotional state when approaching rehabilitation therapies.
There will be 4 sessions during which measurements will be recorded.
1: measurement of this parameter when he or she is in an activity of daily life that is pleasurable. 2: measurement of this parameter when he or she is in an activity of daily life that is of discomfort. 3: Measurement of this parameter during the performance of rehabilitation activities. 4: Measurement of this parameter during rehabilitation activities accompanied with music according to the preferences.
Detailed description
CONTEXT AND MEASUREMENT FREQUENCIES
Four sessions will be held, divided into two parts:
PART 1: Selection of dependent variables. The aim of the first two sessions is to be able to count a reference level for physiological variables in activities that provoke pleasant and unpleasant emotions, so that they can be used as a reference in Part 2; the purpose is to try to avoid dependence on the EVEA tests since the subjects will not always be able to express their emotions. The EVEA test is used as a reinforcer for a possible automatic classifier.
- Session 1: measurement of parameters to the subject when he or she is in an activity of daily life that is pleasurable for him or her in the center. This session will be determined by conversation with the caregiver since it is particular for each subject.
- Session 2: measurement of parameters to the subject when he or she is in an activity of daily life that is of discomfort for him or her in the center. This session will be determined by conversation with the caregiver since it is particular for each subject.
Half of the participants will start with session 2 and then do session 1, while the rest will follow the reverse order.
PART 2. Effect of music on the dependent variables during the performance of rehabilitation exercises
- Session 3: Measurement of parameters to the subject during the performance of rehabilitation activities in the center.
- Session 4: Measurement of parameters to the subject during rehabilitation activities in the center. The session will be accompanied with music according to the preferences of the subject.
The pleasant motivational music to be played during session 4 will be selected by each user according to his or her musical preferences, or, failing that, will be transmitted to us by his or her caregiver. The rehabilitation activity should be a light exercise for the user, such as pedaling, limb extension, or any other that is measurable through inertial units. The specific activity that each user will have to perform will be determined by the medical staff and/or physiotherapist of each center, as it will be limited by the movement capacity of each participant.
Although each session has a different theme, the structure of the sessions is similar. First, the sensors are placed on the volunteer; once it has been verified that the data are collected in an adequate manner, the data recording begins while the user is answering the EVEA test. This first part of the recording will be used as a baseline for the session, which should last at least two minutes. After that, the activity will start, which will not last more than 15 minutes; and to finish, a new EVEA test will be filled in, with identical restrictions to the first test. With these initial and final baselines, the differential of the measurements of each session can be detected, in addition to the analysis of the evolution of the subject during the activity.
For each user, the protocol should be completed in two weeks, during the first week sessions 1 and 2, and during the second week sessions 3 and 4.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 5 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The population who took part in this study attend two different centers for people with special needs: Asociación Sevillana de Parálisis Cerebral (ASPACE) and Centro Específico de Educación Especial Mercedes Sanromá (CEEEMS). ASPACE is a private organization catering mainly for adults with CP. The other center, CEEEMS, is a public specialist school that forms part of the educational network in Andalusia (Spain) and deals mainly with children and teenagers with motor dysfunctions (including CP).
Key inclusion criteria (1 listed)
- 1.People with a recognized disability, caused by a permanent illness or health situation.
Key exclusion criteria (4 listed)
- Present any health situation that is incompatible with the use of assistive technology designed and prototype in the project.
- Have a very limited cognitive ability, which prevents you from following the instructions for the proper use of assistive technology.
- Not having adequate human support.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Average kinetic energy measurements (in joules) using inertial sensors
Time frame: Fifteen minutes.
Four wearable devices in wrist, ankle, chest and head are used. All have inertial units. They provide information in the different contexts (scheduled sessions) about the energy expenditure that these entail. It should be studied whether this parameter is related to the emotional state.
Instantaneous Heart Rate (in seconds)
Time frame: Fifteen minutes.
We used a wearable placed in the chest with Ag/AgCl electrodes for ECG, placed following the Einthoven's II lead positions. The position of R wave is determined using an appropriate algorithm and then time difference between two consecutive R waves is calculated, this time difference is used to calculed HR. We used 30s-length sliding windows with an overlap of 50%. The instantaneous HR is given by the average HR in such a window after removing the outliers.
The ratio between low frequency, (LF) and high frequency, (HF), (LF/HF)
Time frame: Fifteen minutes.
We used a wearable placed in the chest with Ag/AgCl electrodes for Electrocardiogram (ECG) ,placed following the Einthoven's II lead positions. The ratio between low frequency , [0.04 - 0.15] Hz (LF) and high frequency, [0.15 - 4] Hz (HF) components of HRV, (LF/HF), shows the balance between the SNS (Sympathetic Nervous System) and the PNS (Parasympathetic Nervous System).
Temporal parameters of Heart Rate Variability (HRV)
Time frame: Fifteen minutes.
We used a wearable placed in the chest with Ag/AgCl electrodes for Electrocardiogram (ECG) ,placed following the Einthoven's II lead positions. The HRV is especially interesting because it allows to assess the activity of the parasympathetic and sympathetic pathways of the ANS (Autonomic Nervous System). HVR can be measured using temporal parameters such as: SDNN Standard deviation of NN intervals; RMSSD Root mean square of successive differences between normal heartbeats; pNN50 Percentage of successive RR intervals that differ by more than 50 ms.
Tonic Skin Conductance Level (SCL)
Time frame: Fifteen minutes.
This signal is the background tonic of the Electrodermal Activity signal (EDA). It will be measured by dry electrodes that were placed on the hearten and hypothenar eminences of the dominant hand.
Parameters of Phasic Skin Conductance Response (SCR)
Time frame: Fifteen minutes.
It will be measured by dry electrodes that were placed on the hearten and hypothenar eminences of the dominant hand This signal are constituted by the rapid phase components of the Electrodermal Activity signal (EDA). An SCR that cannot be attributed to a distinct stimulus is referred to as non-specific skin conductance response (NS-SCR). This category includes the spontaneous fluctuations in skin conductance that are our case because we measured the signal in periods without stimulus.
Fractal dimension of Electroencephalogram signal (EEG)
Time frame: Fifteen minutes.
The EEG portrays the functioning of the brain. the recording of those signals will be done at a sampling rate of 125 Hz by OpenBCI. OpenBCI (https://openbci.com/) is a low-cost open-hardware device for the measure of EEG signals using 16 channels in positions FP1, FP2, F1, F2, F5, F6, Cz, C3, C4, T7, T8, Pz, P3, P4, O1, O2. The EEG signals are highly complex and dynamic in nature. Fractal dimension (FD) is emerging as a novel feature for computing its complexity. We will use the Higuchi's algorithm.
Spectral Entropy (SE) of EEG signal
Time frame: Fifteen minutes.
The EEG portrays the functioning of the brain. the recording of those signals will be done at a sampling rate of 125 Hz by OpenBCI. SE can be used for computing EEG complexity. To do that, the power spectral density (PSD) must be obtained as a first step . After normalizing the PSD by the number of bins, which can be viewed as a probability density function conversion, the classical Shannon's entropy for information systems is then calculated.
EEG coherence
Time frame: Fifteen minutes.
The interactions between neural systems, operating in each frequency band, are estimated by means of the EEG coherence. While neural synchronization influences EEG amplitude, the coherence between signals captured by one pair of electrodes refers to the consistence and stability of the signal amplitude and its phase. Two brain areas connected should show a signal delay in time domain that is measured as a phase shift in the frequency domain.
Activity of the regions in the brain
Time frame: Fifteen minutes.
We will use Loreta. Loreta is a specific solution to the inverse problem, using algorithms that localize the cortical generators of the observed neuronal firing.
6 secondary outcomes
International Classification of Functioning, Disability and Health (ICF)
Time frame: Through study completion, an average of 2 weeks.
Gross Motor Function Classification System (GMFCS)
Time frame: Through study completion, an average of 2 weeks.
Manual Ability Classification System (MACS)
Time frame: Through study completion, an average of 2 weeks.
Communication Function Classification System (CFCS)
Time frame: Through study completion, an average of 2 weeks.
KIDSCREEN Questionnaire
Time frame: Through study completion, an average of 2 weeks.
SCALE FOR MOOD ASSESSMENT (EVEA)
Time frame: Through study completion, an average of 2 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- BackgroundR. Martinez; A. Salazar-Ramirez; A. Arruti; E. Irigoyen; J. I. Martin; J. Muguerza. A Self-Paced Relaxation Response Detection System Based on Galvanic Skin Response Analysis. 2019. IEEE Access PP(99):1-1
- BackgroundCan Y.S., Chalabianloo N., Ekiz D., Fernandez-Alvarez J., Repetto C., Riva G., Iles-Smith H., Ersoy C. Real-Life Stress Level Monitoring Using Smart Bands in the Light of Contextual Information. IEEE Sensors Journal. 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel M. Gomez-Gonzalez, Phd principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Physically Challenged, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average kinetic energy measurements (in joules) using inertial sensors (time frame: Fifteen minutes.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05621057, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.