NCT07330921 Development and Effectiveness of the Participatory Adapted 3D Sedentation System (SSAP3D).
| NCT ID | NCT07330921 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigación Sanitaria Aragón |
| Condition | Neuromotor Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-04-03 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2026-04-03 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Medical Situation of Neuromotor Disfunction * Be user of some type of adapted seating system * Age between 2-6 years * Have head control levels of 3 to 8 on the Level of Sitting Scale (LSS) * Be able to maintain a standing position for at least 10 seconds, with or without external assistance. Exclusion Criteria: * Presenting moderate or severe cognitive impairment, which generates significant difficulties in understanding the instructions given by the evaluator * Having suffered a traumatic injury o surgical process in the 6 months prior to the start of the study or during the study
Contact & Investigator
Sandra Calvo, PhD
PRINCIPAL INVESTIGATOR
Universidad de Zaragoza
Frequently Asked Questions
Who can join the NCT07330921 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 6 Years, studying Neuromotor Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07330921 currently recruiting?
Yes, NCT07330921 is actively recruiting participants. Contact the research team at danielrubio96@outlook.es for enrollment information.
Where is the NCT07330921 trial being conducted?
This trial is being conducted at Zaragoza, Spain.
Who is sponsoring the NCT07330921 clinical trial?
NCT07330921 is sponsored by Instituto de Investigación Sanitaria Aragón. The principal investigator is Sandra Calvo, PhD at Universidad de Zaragoza. The trial plans to enroll 12 participants.