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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 6
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
AIDIMO (Asociación para la Investigación en la Discapacidad Motriz)
RECRUITING
Zaragoza
Contact Information
Primary
Daniel Rubio, PhD Student
danielrubio96@outlook.es
+34 665758689
Backup
Sandra Calvo, PhD
sandracalvo@unizar.es
+34 661833194
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 12
Treatments
Experimental: SSAP3D Intervention
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.
Related Therapeutic Areas
Sponsors
Leads: Instituto de Investigación Sanitaria Aragón
Collaborators: Universidad Pontificia Comillas

This content was sourced from clinicaltrials.gov