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.
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)
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
Single group
SSAP3D Intervention
DeviceThe 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.
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.
Postural control
Changes in the score of Postural control measure (SPCM): a 34-item scale designed to measure changes in postural alignment and functional movement produced by an intervention focused on adapted seating systems. It has shown good psychometric properties for children with Neuromotor Dysfunction. 1. Postural Alignment Section (SPCM-A): 22 items, scored on a 4-point ordinal scale. From 1: Neutral alignment (typical posture), to 4: Severe deviation 2. Functional Movement Section (SPCM-F): 12 items, scored on a 4-point ordinal scale. From 1: Unable to initiate the task, to 4: Successful completion of the task
Functionality of upper extremity
Change in the score on the Box and Block Test (BBT). The BBT measures the functionality of the upper extremity in children with Neuromotor Dysfunction, specifically gross motor dexterity in a unimanual way in terms of speed and accuracy.
Achievement of Functional goals
Change in the score on the Canadian Occupational Performance Measure (COPM). The COPM is designed to identify occupational performance problems through a semi-structured, clinically useful and responsive interview that allows for person-centered practice. The COPM will be used to establish three occupational performance problems in each child, which will be identified by the family and used as functional treatment goals. * Importance Score: The client rates the importance of each activity identified for their life, using an ordinal scale from 1 to 10. 1: Not important at all. 10: Extremely important. * Performance: How well do you currently perform the activity? 1: Unable to perform at all (or with great difficulty). 10: Able to perform extremely well (or without difficulty). * Satisfaction: How satisfied are you with your current level of performance in this activity? 1: Not at all satisfied. 10: Extremely satisfied.
Participation in different environments
Change in the score on the Young Children's Participation and Environment Measure (YC-PEM). Measurement instrument filled out by the parents or primary caregiver, which analyzes the different activities of the child between 0-5.9 years of age, assessing their level of participation and the qualities of the environment in which they develop. 1. Frequency of Participation 8 points, from 0 (never) to 7 (one or more times a day). A higher score indicates greater frequency of participation in these activities. 2. Level of Involvement 5 points, from 1 (not very envolved) to 5 (Very involved.).A higher score indicates a greater level of interaction and active participation in activities. 3. Percentage of Desired Change Percentage (0% to 100%). A lower percentage suggests greater satisfaction with the child's current participation. A higher percentage indicates that the caregiver desires change. 4. Environmental Support (Facilitators and Barriers) Percentage (0% to 100%)
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Instituto de Investigación Sanitaria Aragón
Lead sponsor
Universidad Pontificia Comillas
Collaborator
