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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-6
SponsorInstituto de Investigación Sanitaria Aragón

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SSAP3D Intervention

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators

Instituto de Investigación Sanitaria Aragón

Lead sponsor

Universidad Pontificia Comillas

Collaborator