Clinical trial NCT05621057: Evaluation Methodology of Emotional States for People With Cerebral Palsy
Official title: Augmentative Affective Interface (AAI): Evaluation Methodology of Emotional States for People With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cerebral Palsy
Physically Challenged
Emotional Adjustment
Keywords: emotional measure
image processing
physiological parameters
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1.People with a recognized disability, caused by a permanent illness or health situation.

Exclusion criteria are:

1. Present any health situation that is incompatible with the use of assistive technology designed and prototype in the project.
2. Have a very limited cognitive ability, which prevents you from following the instructions for the proper use of assistive technology.
3. Not having adequate human support.

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Primary outcomes:
measure: Average kinetic energy measurements (in joules) using inertial sensors
timeFrame: Fifteen minutes.
measure: Instantaneous Heart Rate (in seconds)
timeFrame: Fifteen minutes.
measure: The ratio between low frequency, (LF) and high frequency, (HF), (LF/HF)
timeFrame: Fifteen minutes.
measure: Temporal parameters of Heart Rate Variability (HRV)
timeFrame: Fifteen minutes.
measure: Tonic Skin Conductance Level (SCL)
timeFrame: Fifteen minutes.
measure: Parameters of Phasic Skin Conductance Response (SCR)
timeFrame: Fifteen minutes.
measure: Fractal dimension of Electroencephalogram signal (EEG)
timeFrame: Fifteen minutes.
measure: Spectral Entropy (SE) of EEG signal
timeFrame: Fifteen minutes.
measure: EEG coherence
timeFrame: Fifteen minutes.
measure: Activity of the regions in the brain
timeFrame: Fifteen minutes.
Secondary outcomes:
measure: International Classification of Functioning, Disability and Health (ICF)
timeFrame: Through study completion, an average of 2 weeks.
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: Through study completion, an average of 2 weeks.
measure: Manual Ability Classification System (MACS)
timeFrame: Through study completion, an average of 2 weeks.
measure: Communication Function Classification System (CFCS)
timeFrame: Through study completion, an average of 2 weeks.
measure: KIDSCREEN Questionnaire
timeFrame: Through study completion, an average of 2 weeks.
measure: SCALE FOR MOOD ASSESSMENT (EVEA)
timeFrame: Through study completion, an average of 2 weeks.
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Isabel M. Gomez
state: Andalucia
Study officials:
affiliation: University of Seville
name: Isabel M. Gomez-Gonzalez, Phd
role: PRINCIPAL_INVESTIGATOR
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