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Development and Effectiveness of the Participatory Adapted 3D Sedentation System (SSAP3D).

Study acronym: SSAP3D
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated July 13, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Start date changed from estimate of Apr 2026 to Apr 3, 2026v3
  2. Notable Recruitment openedv2 Show 4 more changesShow less
    • Start date: Dec 13, 2025 to Apr 2026
    • Primary completion pushed from Jul 30, 2026 to Sep 30, 2026
    • Secondary endpoints revised (7)
    • Site details revised
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Problems with postural control cause difficulties in children's motor development, leading to significant structural and functional complications, including pelvic obliquity, scoliosis, and asymmetries in both active and passive ranges of motion. All these difficulties affecting posture control have a negative impact on children's functional autonomy and independent participation in their daily activities, as well as on their interaction with different environments, mainly family, social, and educational. In view of this situation, the 3D Adaptive Sitting System "SSAP3D", a 3D pelvic ser with a self-extracting abductor cushion, is proposed as an alternative. The main objective is to develop and test a novel 3D-printed adaptive seating system, called SSAP3D, tailored to individual needs of children with Neuromotor Dysfunction, to assess whether it promotes the functional performance of children in their daily and meaningful activities. A secondary objective is to analyze whether the use of SSAP3D promotes the children's participation in different environments compared to a conventional seated system. The sample is estimated at 12 children, all of them were between 2-6 years old and with Neuromotor Dysfunction from early attention centers, as well as from private rehabilitation centers or associations. The intervention program will be the same for each participant, but in different temporal order. 6 children will use during the first 6 weeks the 3D seat and the following 6 weeks their usual seating system; the others 6 children inverted order. The 3D seat will be made individually for each child. The device will be delivered 3 weeks after the scanning-data collection accompanied by guidelines for use. There will be 2 online follow-up sessions. Hypothesis: the implementation of the SSAP3D allows to ensure the postural requirements of children with Neuromotor Dysfunction and to favor their functional performance in daily and meaningful activities at home, at school and in their community. In addition, it will have a positive impact on the quality of life perceived by the families related to the characteristics of the seat.
Trial Details
NCT Number NCT07330921
Lead Sponsor Instituto de Investigación Sanitaria Aragón
Collaborators: Universidad Pontificia Comillas
Conditions
(from sponsor)
Neuromotor Dysfunction
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov