**2. Material and methods**

*Therapy Approaches in Neurological Disorders*

education, and social engagement [5, 6].

since time immemorial [7].

trainer/support walker" [8].

One of the causes of disability is neural tube defects, which are the most serious congenital malformations of the central nervous system and the spine. They are the second major congenital anomaly after cardiac malformations, with a frequency that ranges between 0.5 and 2 per 1000 pregnancies, although in some geographical regions, for example, in northern China, frequencies of up to 10 per 1000 births. Furthermore, they account for up to 29% of neonatal deaths associated with congenital anomalies in low-income settings. Both the clinical manifestations and the resulting disabilities and mortality depend on its level and extent [2]. The structural defect occurs at any level of the neuraxis, from the brain to the sacrum; These neural tube defects located in the spine are classified as occult spina bifida and open or cystic spina bifida, in the latter, spina bifida is present, but accompanied by a protrusion of a meningeal sac with cerebrospinal fluid with neural tissue inside or without it and are classified as Meningocele, Myelomeningocele and Rachischisis with Mieloschisis. Myelomeningocele is the most serious form of spina bifida cystica that presents as a chronic disease, it produces a strong psychosocial impact on the child and their family since the child may present motor, urological, orthopedic and sometimes cognitive impairment [3, 4]. This can be done damaging effects on a child's well-being,

Failure to adopt bipedal position implies the limitation of voluntary motor skills such as locomotion, transfers and self-care, sphincter involvement, restricting social and school participation. This is the reason why orthotic attachments or devices to achieve the maintenance of the bipedal position, have been proposed

Recent research even recommends a "24-hour postural management program that you should consider including both a passive standing component and an active component using a stander that steps, vibrates, oscillates, sways, turns, bounces, moves from sit-to-stand under users' own power, allows users to self-propel, and so on, or other devices that combine weight-bearing and movement such as a gait

Assisted standing involves using a device to help place load through a person's

feet. Standing devices and orthoses provide a stable mechanical support for weight bearing in the supine, prone or upright positions, depending on the device chosen; however, a precise and timely evaluation of individual needs must select the most appropriate design of standing device, orthoses, or both. These benefits include preservation of muscle length and range of joint movement via the stretch that occurs during standing (predominantly of the hip and lowerlimb muscles), delayed onset of scoliosis, increased bone density (thereby reducing the risk of fractures), fewer muscle spasms and better respiratory function (including voice control). Research on standing for other conditions has also suggested improved circulation, digestion, and bowel and bladder function. Clinical opinion on standing indicates other benefits, including pressure relief (which improves skin integrity), improvement of well-being and better

In addition, for these people, there is the social stigma of depending on others for functional mobility, which is why an assistive device is necessary that facilitates the bipedal position, ambulation in the environment and development of activities typical of age, without assistance from another person and who

One of the fields of the human body movement professional is precisely the design, prescription and evaluation of the use of this type of device for standing,

contribute positively to society as a whole [11, 12].

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sleep [9, 10].

The approach to the design of machinery that was proposed in this project considered for its realization the steps of the engineering design flow [14], that is to say:


The purpose of the probability study is to verify the possible success or failure of a proposal, both from a technical and economic perspective.

4.Synthesis of creative design.

In this phase of design, researchers must act as physiotherapists, "empirical engineers," inventors, and artists, to create the machine.

5.Preliminary design and development.

Drawings of the machine as a whole and of the specific parts of it, the dimensions and important notations, as well as auxiliary sectional views, that fully explain the proposed design. In addition, kinematic studies are conducted, which include the design of the machine and the possible movements that it should conduct.

6.Detailed design.

Detailed design refers to the actual rigging and sizing of all individual components, both purchased and manufactured, that make up the total product, device, or system. The assistance of experts in the different areas was necessary in order to carry out the stander on the right track.

7.Prototype construction and testing.

At this stage, the parts were manufactured, the commercial components were purchased and the machine or system, after the assembly, is ready for evaluation and testing. After the necessary changes and/or modifications have been made, the new components are incorporated into the prototype assembly to continue with the tests and evaluations. This process was performed until the designer, in this case the researchers, were satisfied with the stipulated specifications.

8.Production design, this stage is not part of this project as it is a pilot test.

This was the prototype of the standing frame that was used in the case, which was subjected to evaluation in the prototype workshop of the Faculty of Engineering of the National University, and to an expert judgment (**Figure 1**).

**Figure 1.** *Graphic design of the prototype.*

Based on the prototype, a case study was designed with a 10-year-old patient with myelomeningocele type spina bifida level T12 - L4, the most relevant sequelae of which were bilateral-grade IV/V vesicourethral reflux, flaccid neurogenic bladder in catheterization intermittent from the age of 4 years old, bilateral hydronephrosis, bilateral dysplasia of the hips and coxa varas, flaccid paraplegia, among others.

The researchers understood, assumed and classified this research project as minimal risk, given that other stanchions have been created in the world, which have facilitated the study and description of the risks derived from its use in the adult population [15], and to a lesser extent in the pediatric population, with an inability to acquire the bipedal position. The possible risks, their handling and control are known and foreseen by the researchers. These risks include signs of orthostatism, diaphoresis, emesis, pressure zones, allergy to materials, tinnitus, paresthesia, fall, tachycardia, bradypnea or polypnea [16].

The benefit derived from the use of the stander was based on the care of the conditions that generally affect people unable to adopt the bipedal position [1]. Therefore, in the cost–benefit ratio, the risks inherent to the research were widely outweighed by the benefits provided by assisted standing in this type of population, being a novel and reasonable orthosis, insofar as it was intended to attend a sequel and a need that the Colombian health system is not prepared to meet and has completely neglected in the research study subject.

Confidentiality was guaranteed by the researchers for both the study subject and his family.

According to Title III of the current regulations, in this study an informed consent was obtained for the research subject, with prior evaluation by the psychology service of the Faculty of Medicine of the National University in which it was certified that the subject of study, can understand, reason and logic, which allows

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*Design of a Standing Device for Children with Spinal Dysraphysm*

you to understand the importance and role of your participation in this research. In the same way, they proceeded to obtain informed consent from their parents.

A search was carried out for experts in various areas such as pediatric neurology, biomedical engineering, biomechanics and medical technology; who could evaluate the different characteristics of the stander. For this, five expert professionals were contacted, of which 80% were physiotherapists and 20% belonged to mechanical

The characteristics of both the shape (design, safety, resistance, weight, mobility, esthetics, among others) and the bottom of the standing frame were evaluated with a view to incorporate the changes, modifications and suggestions received by the judges into the final prototype. At the request of one of the evaluators, the researchers made a technical specification sheet, which could unify a technical language that is understandable to the reader. The evaluation was conducted using

*DOI: http://dx.doi.org/10.5772/intechopen.97758*

**3. Results from the expert judgment**

**4. Criteria for the evaluation of the stander**

The grade point average for this criterion was excellent.

**4.2 Security provided by the patient standard**

One aspect highlighted by one of the experts was the fact of considering standard measures of Colombian architecture, such as the width of the doors, and the standardized measures of wheelchairs, to provide better accessibility to various spaces.

In this criterion, the experts argued that some improvements must increase safety, such as lateral supports on the back and seat. Another evaluator expressed concern about how safe an obese patient might be. The average grade for this

The average qualification for this criterion was very good, although we insist on

**4.3 Design of supports to avoid pressure zones in the body segments**

the following qualification criteria:

engineering.

1.Excellent

2.Very good

3.Good

5.Bad

4.Regular

6.Very bad

**4.1 Design creativity**

criterion was very good.

reviewing any pressure zones.

you to understand the importance and role of your participation in this research. In the same way, they proceeded to obtain informed consent from their parents.
