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

NCT07330921 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Neuromotor Dysfunction

Interventions

DEVICE

SSAP3D Intervention

The intervention is the same for the whole sample but with deferent sequences: group 1 will perform the intervention following the sequence "SSAP3D + conventional system" and group 2 will perform the intervention with the opposite sequence, "conventional system + SSAP3D". Both groups will use 6 weeks the SSAP3D and 6 weeks the conventional system. During the 6 weeks of intervention using SSAP3D, 2 online follow-up sessions will be carried out with the family (weeks 6 and 8 for group 1; weeks 9 and 11 for group 2) with the aim of supervising the correct use and maintenance of the seat, as well as resolving possible doubts and/or the need to make anu modifications or adjustments to the seat, both in the family and school environment of the participant.

Sponsors & Collaborators

  • Universidad Pontificia Comillas

    collaborator OTHER

  • Instituto de Investigación Sanitaria Aragón

    lead OTHER

Principal Investigators

  • Sandra Calvo, PhD · Universidad de Zaragoza

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-09-30
Completion
2026-10-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07330921 on ClinicalTrials.gov