Evaluation Methodology of Emotional States for People With Cerebral Palsy

NCT ID: NCT05621057

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-02-03

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.

Conditions

Cerebral Palsy; Physically Challenged; Emotional Adjustment

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

-

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Isabel Gómez González

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isabel M. Gomez-Gonzalez, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Seville

Locations

Isabel M. Gomez

Seville, Andalusia, Spain

Countries

Spain

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 32033498 (View on PubMed)

Correa, 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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 31520963 (View on PubMed)

Albiol-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.

Reference Type: BACKGROUND

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).

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 26737830 (View on PubMed)

Merino 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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 38793103 (View on PubMed)

Other Identifiers

2022_D6

Identifier Type: -

Identifier Source: org_study_id