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NCT05621057

Evaluation Methodology of Emotional States for People With Cerebral Palsy

Active, enrolled Last updated 19 September 2024
What this trial tests

trial in Cerebral Palsy in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 November 2023
Primary endpoint
1 December 2024
3 February 2025

Quick facts

Lead sponsorUniversity of Seville
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment40
Start date1 November 2023
Primary completion1 December 2024
Estimated completion3 February 2025
Sites1 location across Spain

Conditions studied

Sponsor

University of Seville

Who can join

Adults 5 to 55, any sex, with Cerebral Palsy or Physically Challenged. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Emotional State Measurement Trial (EMOPROEXE): A Protocol for Promoting Exercise in Adults and Children with Cerebral Palsy.
    Gómez-González IM, Castro-García JA, Merino-Monge M, Sánchez-Antón G, et al · · 2024 · cited 1× · PMID 38793103 · DOI 10.3390/jpm14050521
  2. Emotional State Measurement Trial (EMOPROEXE):a Protocol for Promoting Exercise in Adult and Children with Cerebral Palsy
    Gomez-Gonzalez IM, Castro-Garcia JA, Merino-Monge M, Sanchez-Anton G, et al · · 2024 · DOI 10.20944/preprints202401.1607.v1

Verify or expand the search:

Other recruiting trials for Cerebral Palsy

Currently open trials in the same condition.

Other University of Seville trials

Trials by the same sponsor.

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Data sources for this page

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