Custom 3D adaptive seating (SSAP3D) for children with neuromotor dysfunction
Development and Effectiveness of the Participatory Adapted 3D Seating System (SSAP3D) and Its Impact on the Daily Performance of Children With Neuromotor Dysfunction and Their Families: Pilot Study
This project will test whether a custom 3D‑printed adaptive seat (SSAP3D) helps children aged 2–6 with neuromotor dysfunction improve posture and daily functioning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | Instituto de Investigación Sanitaria Aragón Academic / other |
| Locations | 1 site (Zaragoza, Zaragoza) |
| Trial ID | NCT07330921 on ClinicalTrials.gov |
What this trial studies
This pilot uses a randomized crossover design in two groups who each use both the SSAP3D and a conventional seating system in opposite sequences. Investigators will scan each child, 3D‑print an individually tailored SSAP3D seat, and deliver it for six weeks of home use with two online follow‑ups. Trained physiotherapists will perform standardized quantitative evaluations at four timepoints at AIDIMO in Zaragoza to measure functional performance and posture. The study focuses on children who already use adapted seating and have specified head control and standing abilities.
Who should consider this trial
Good fit: Children aged 2–6 with neuromotor dysfunction who already use an adapted seating system, have Level of Sitting Scale head control scores 3–8, and can maintain standing for at least 10 seconds (with or without assistance).
Not a fit: Children with moderate or severe cognitive impairment that prevents following instructions, those who have had recent trauma or surgery within six months, or those outside the specified age and functional criteria are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the SSAP3D could improve postural control, functional independence, and participation in daily activities for children with neuromotor dysfunction.
How similar studies have performed: Individualized seating and some 3D‑printed assistive devices have shown promising but limited evidence, and the participatory SSAP3D approach is relatively novel in this population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zaragoza, Zaragoza
- AIDIMO (Asociación para la Investigación en la Discapacidad Motriz) — Zaragoza, Zaragoza, Spain (Recruiting)
Study contacts
- Principal investigator: Sandra Calvo, PhD — Universidad de Zaragoza
- Study coordinator: Daniel Rubio, PhD Student
- Email: danielrubio96@outlook.es
- Phone: +34 665758689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.