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Evaluation Methodology of Emotional States for People With Cerebral Palsy

StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 19, 2024 (before its estimated December 1, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Primary completion date: May 1, 2024 to Dec 1, 2024
    • Study completion date: Jun 3, 2024 to Feb 3, 2025
    v4
  3. Primary completion date: May 1, 2023 to May 1, 2024
    • Start date: Feb 1, 2023 to Nov 1, 2023
    • Study completion date: Jun 3, 2023 to Jun 3, 2024
    v3
  4. Trial status: Not Yet Recruiting to Active, Not Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Feb 1, 2023 to May 1, 2023
    • Study completion date: Mar 3, 2023 to Jun 3, 2023
    • Start date changed from estimate of Jan 1, 2023 to Feb 1, 2023
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05621057
Lead Sponsor University of Seville
Conditions
(from sponsor)		 Cerebral Palsy, Physically Challenged, Emotional Adjustment
Related terms Cerebral Palsy
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov