Actively Recruiting

Phase Not Applicable
Age: 2Years - 6Years
All Genders
NCT07330921

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

Led by Instituto de Investigación Sanitaria Aragón · Updated on 2026-04-06

12

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

I

Instituto de Investigación Sanitaria Aragón

Lead Sponsor

U

Universidad Pontificia Comillas

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 2Years - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Medical situation of Neuromotor Dysfunction
  • Currently uses some type of adapted seating system
  • Age between 2 and 6 years
  • Head control levels of 3 to 8 on the Level of Sitting Scale (LSS)
  • Able to maintain a standing position for at least 10 seconds, with or without external assistance
Not Eligible

You will not qualify if you...

  • Moderate or severe cognitive impairment causing difficulties in understanding evaluator instructions
  • Traumatic injury or surgical process in the 6 months before or during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

AIDIMO (Asociación para la Investigación en la Discapacidad Motriz)

Zaragoza, Zaragoza, Spain, 50011

Actively Recruiting

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Research Team

D

Daniel Rubio, PhD Student

CONTACT

S

Sandra Calvo, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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