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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Performance
研究概览
简要总结
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.
详细描述
This project employs a pilot study of a crossover clinical trial with two groups with two 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.
Intervention Protocol:
At the beginning of the study, both groups will carry out a 30-minute evaluation session for taking body measurements and collecting data through the scanning of the participant.
Through these measures, the investigators will design a SSAP3D for the participant, an individual 3D printed seat. Three weeks after the data collection session, the SSAP3D will be delivered to the family with a basic guideline on the correct use of the seat.
The intervention, which consist in the use of the SSAP3D during the whole day by the child and the family for 6 weeks, will be controlled by two online follow-up sessions with the family.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: SSAP3D Intervention (Device)
结局指标
主要结局
Performance
时间窗: from enrollment to the end of intervention, as in the two-follow-up assessment, assessed up to 9 months
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.
次要结局
- Quality of Life on Pediatric participants(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)
- Family Satisfaction(from enrollment to the end of intervention, as in the two-follow-up assessment, assessed up to 9 months)
- Postural control(from enrollment to the end of intervention, as in the two-follow-up assessment, assessed up to 9 months)
研究者
Sandra Calvo Carrión
Phd
Instituto de Investigación Sanitaria Aragón