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

NCT07330921 | Not Yet Recruiting DMC

• 1 other identifier: UZ-Asientos 3D
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromotor Dysfunction

Keywords

Performance; Children; Seating System; 3D Technology; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Performance

  Change in the score on the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). The PEDI-CAT is a computerized and adaptive questionnaire completed by the family that measures the child's functional performance in the areas of activities of daily life, mobility, social/cognitive function and responsibility in complex daily tasks. In addition, in children with Neuromotor Dysfunction, the PEDI-CAT has been shown to be a valid instrument to measure functional ability. 30-70: Considered the expected range for age, indicating normal functional capacity. \< 30: Suggests lower than expected functional capacity for age.

  from enrollment to the end of intervention, as in the two-follow-up assessment, assessed up to 9 months

Secondary Outcomes (7)

• Postural control

  from enrollment to the end of intervention, as in the two-follow-up assessment, assessed up to 9 months

• Functionality of upper extremity

  from enrollment to the end of intervention, as in the two-follow-up assessment, assessed up to 9 months

• Achievement of Functional goals

  from enrollment to the end of intervention, as in the two-follow-up assessment, assessed up to 9 months

• Participation in different environments

  from enrollment to the end of intervention, as in the two-follow-up assessment, assessed up to 9 months

• Quality of Life

  from enrollment to the end of intervention, as in the two-follow-up assessment, assessed up to 9 months

Study Arms (1)

SSAP3D Intervention

EXPERIMENTAL

Participants will use the SSAP3D during the whole day by the child and the family for 6 weeks. At the beginning of the study, will carry out a session for taking body measurements and collecting data through the scanning of the participant. From this data collection, the SSAP3D will be digitally created. After all the necessary modifications have been made, the seat will be printed using FDM 3D Printer. Once the printing is finished, the removable systems and padding will be adjusted and placed by the designed interlocking systems. Three weeks after the data collection session, the SSAP3D will be delivered to the family and the 6-weeks intervention will begin. The correct elaboration of the device will be checked. Also, basic guidelines on the correct use of the seat, moments of use and maintenance of the seat will be explained to both the child and the families. This information will also be communicated to the school staff and to the different early care centers they attend.

Device: SSAP3D Intervention

Interventions

SSAP3D Intervention DEVICE

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.

SSAP3D Intervention

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead
• Universidad Pontificia Comillas: collaborator

Study Sites (1)

AIDIMO (Asociación para la Investigación en la Discapacidad Motriz)

Zaragoza, Zaragoza, 50011, Spain

Location

Study Officials

• Sandra Calvo, PhD

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Rubio, PhD Student

CONTACT

+34 665758689; danielrubio96@outlook.es

Sandra Calvo, PhD

CONTACT

+34 661833194; sandracalvo@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: January 9, 2026
• Study Start: December 13, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-11

Locations

ES (1)