Adidsuda Fuengfoo MD^{1,2, *}, Pawarin Tuntariyanond Ph.D³, Wirongrong Yasasindhu M.Sc.⁴, Nalin Khumlee B.Sc.⁴

¹Division of Developmental and Behavioral Pediatrics, Department of Pediatrics, Queen Sirikit National Institute of Child Health, Bangkok, Thailand
²College of Medicine, Rangsit University, Bangkok, Thailand
³Department of Textile Science Faculty of Agro-Industry Kasetsart University, Bangkok, Thailand
⁴Physical Therapy Unit, Department of Rehabilitation Medicine, Queen Sirikit National Institute of Child Health, Bangkok, Thailand

^*Corresponding Author: Adidsuda Fuengfoo, Division of Developmental and Behavioral Pediatrics, Department of Pediatrics, Queen Sirikit National Institute of Child Health, College of Medicine, Rangsit University, Bangkok, Thailand

Abstract
There are 3.7 million disabled people in Thailand or 5.5 % of the nation's population. About 140,000 are disabled children under the age of 15 (Office of Statistics, 2017) [1]. Cerebral Palsy (CP) is the most common motor disability of childhood. The incidence of CP is estimated to be 2 - 2.5 per 1,000 live births in developed countries, 1.5 - 5.6 per 1,000 live births in developing countries, and 2-7 per 1,000 live births in Thailand [2]. CP is a condition with impaired brain function that controls the movement system and causes muscle spasms commonly occur in 70 % to 80 % of children with disabilities. If left untreated, a complication may develop and cause permanent disabilities or limb deformation [3,4]. Several interventions were implemented to reduce the risk or severity of CP and prevent complications. Appropriate treatments [5,6] can restore function and improve motor skills which can help them reach their full potential and reduce caregiver burden. They were close-fitting suits which are measured to fit each individual. It has been recommended for CP children with athetosis, hypotonia, or spasticity. The goals are to reduce muscle contracture, improve postural alignment, proximal stability, and other body functions [9,10]. Parents of CP children encouraged their child to wear Lycra garments at home as a complementary treatment method [11]. Some studies from VirginiaKnox12 showed that half of CP children who achieved a wear time of 4hours a day for 4 weeks had improved body balance, while the rest withdrew from the trial because of discomfort. After collecting feedback through an in- depth and semi-structured interview, cerebral palsy specialists and caregivers found that the garment should be wearable in hot and humid weather like in Thailand, easy to care and budget-friendly to encourage regular wear for more effective results. Based on this review, epidemiological evidence is needed for the clinical decisions on whether such garments are beneficial for CP children. However, there are only a few pieces of literatures available to inform these decisions. Therefore, QSNICH conducted this study to expand further epidemiological evidence on the efficacy of the use of Lycra garments in CP children.

Objectives
1 To evaluate the clinical effects of Lycra garments on the posture and balance of CP children.
2 To evaluate product satisfaction, acceptance, and life quality of CP children before and after using the Lycra suits.

Keywords: lycra garments, children with cerebral palsy

Material and Methods
1. Garment Materials
The garments were not only designed to meet the requirement of functionality, but also provide comfort to users. Power net fabric was selected to make the garment. It is strong enough for girdles and compression garments, which appropriate for postural corrections. Its honeycomb jacquard structure and tiny holes give the fabric an excellent air permeability with its OEKO-TEX standard. Various fastening devices (fasteners) including zips, hooks, and Velcro were added to the garment making it easier to put on and take off. Plastic boning was sometimes used in specific parts for additional support over the trunk and posture in a sitting position.

2. Assessment Test
Physical therapists applied several clinical assessments before and after the completion of the intervention as follows:

2.1 Functional Balance Grade [13] which consists of 5 levels from low to high: level 0 (inability to balance posture), level 1 (still position which needed considerable assistance, level 4 (maintain steady balance without handhold support.)

2.2 Gross Motor Function Measure: (GMFM 66) [14]: Children were assessed using the Gross Motor Function Measure (GMFM) which assesses gross motor abilities of children with cerebral palsy in five dimensions: (1) lie and roll, (2) sit, (3) craw and kneel, (4) stand, and (5) walk, run, and jump. Assessing posture and balance at pre-trial and during trial of the participants. Additional surveys were distributed to the patient’s caregiver to measure their satisfaction and quality of life of their child after the trial:

2.3 Satisfaction survey was distributed to parents at post-trial to measure: ease of use, postural improvement and attitude which are assessed as follows: 1= poor; 2= fair; 3=good; and 4= very good.

2.4 The Cerebral Palsy Quality of Life for Children-Thai version (CP QOL-Child Thai version) [15]: was applied before and after wearing the garments.

2.5 Sampling criteria
The inclusion criteria were CP children as follows:

• A diagnosis of cerebral palsy
• Age between 3 - 10 years
• CP type of athetoid and diplegia
• Symptoms severity is at level 3-4 of Gross Motor Function Measure Classification System (GMFCS)
• No other complications: e.g., seizures vision or hearing impairment (Vision and hearing screening are performed by a specialist)
• Visited a physical therapist one time per week.

Children were divided into 2 groups: Five CP children in experimental group were asked to wear the garments during the trial, while five CP children in control group received only conventional exercise therapy without wearing the garments.

Method
Research Design
Table 1: Interpretation of Functional Balance Grades. The IRR (inter-rater reliability ) at pre-and post-trial of the target groups were measured by two specialists. The kappa statistic was used to test inter-rater reliability (Kappa values = 0.8)

A repeated measures design: pre-and post-intervention Assessments were conducted in the experimental and control group to measure Functional Balance Grade, GMFM 66, and CP QOL-Child. Intervention Protocol: The garments for children in the experimental group were adjusted to fit each individual. They were asked to put the garment on for 40-60 minutes and observed if there were any whether numbness, pain, or irritation caused by constriction and pressure on any part of the suit or if the children could move or change into various positions easily. The suits were adjusted at a specific point that was not concise. Cleaning and usage instructions were provided to the sample group: handwashing is best to prevent excessive wringing and stretching. If using a washing machine, place the spandex garments in a mesh lingerie bag and use the gentle cycle. Use a mild detergent that contains no chlorine bleach and air-dry the garment away from direct heat and sun.

1. The experimental group was asked to wear a Lycra garment for 6-8 hours per day for 6 weeks. It could be taken off if there were any irritation, discomfort, or difficulty breathing, and put on again after the symptoms disappear until achieved the scheduled baseline time. The trial was monitored and reported to the researchers every week.
2. At the end of the intervention, both groups were asked to complete Functional Balance Grade, GMFM 66, satisfaction survey, and quality of life assessment.

Study Participants
Ten CP children who visited the Child Development Centre at Queen Sirikit National Institute of Child Health (QSNICH) between January 1 and December 31, 2019, were enrolled. All of them were divided into two groups. Informed consent was obtained from parents.

Statistical Analysis
T-test was used to compare the pre-and post-intervention results.

Ethics
The present study was approved by the Office for Ethics in Human Research, Ministry of Public Health, Thailand in 2017 (Ref. Code. 60- 039) and was conducted in accordance with the Declaration of Helsinki. Case 1 and 2 were CP children with athetoid. Their Functional Balance Grades were in level 3 (improvement in sitting balance after wearing the bodysuit) and improved to level 4 after wearing the suit. They were able to maximize the range of motion in all directions as shown in (Table 2) (Figures 1 and 2) showed the result of CP children with diplegias (Case 3 to 5) before and after the intervention. During the trial, their sitting balance was improved from level 3 to level 4 (able to sit with the torso straight but still having trouble reaching to the left with the back slightly tilt to the left). After wearing the suit, the patients were able to maintain steady balance and widen the range of motions in all directions.

Results
Table 2: Comparing of the balance ability between the experimental and control group

Figure 1: Functional Balance Grades of the experimental group before the intervention

Figure 2 Functional Balance Grades of the experimental group after the intervention

Table 3: Gradual improvement of gross motor abilities

(Table 3) shows a gradual improvement of gross motor abilities particularly on sitting, crawling, and kneeling, walking, running, and jumping of Case 1 and 2. The results before and after the intervention of participant 3 in the experimental group were improved. Lying, rolling, crawling, and kneeling abilities were better while wearing the suit and got higher scores during the trial. The GMFM66 showed a significant change in sitting, rolling, running, and jumping. However, there were no significant changes in standing, crawling, and kneeling after the end of the trial. The results before and after the trial of the experimental group were significantly different, while the results of the control group had no significant differences statistically. The garment satisfaction
survey was done by caregivers of 5 CP children with diplegia who wore the 3^rd version of the suit for 6-8 hours per day for 6 weeks as shown in (Table 4).

Table 4: Satisfaction survey towards the use of the suits

The life quality of 5 CP children aged between 4-12 years old were increased at the end of the trial. The overall score of post-trial were higher than pre-trial as shown in the (Table 5 and Table 6). Parents were given an instruction before responding to the survey. The survey focused on children’s attitude, not what they could do or could not do consisting of 10 areas:

1. Feelings toward friends and family (Total score of 144 points, pre- trial mean score = 88 points, post-trial mean score = 120 points, P = 0.001)
2. Social engagement (total score was 45, pre-trial mean score = 31 points, post-trial mean score = 39 points, with a significant difference of P = 0.001).
3. Communication Skills (Total score of 27, pre-trial mean score = 15.4 points, post-trial mean score = 6 points with a significant difference (P = 0.001).
4. Health (Total score = 90 points, pre-trial mean score = 54 points, post-trial means score =73 with significantly different of P = 0.003)
5. Feeling of body functions (Total score = 27 points, pre-trial mean score =18, post-trial means score = 23.6 points with significant difference of P = 0.002)
6. Feelings towards daily life (Total score = 27, pre-trial mean score = 15.4, post-trial means score = 22.85 with significant difference of P=0.001)
7. Pain, annoyance, or boredom (Total score = 77 points, pre-trial mean score =38 points, post-trial means score = 21 with a significant difference of P = 0.001)
8. Service access (Total score = 54 points, pre-trial mean score = 21.4 points, post-trial means score = 25.6 points, significant difference (P = 0.004)
9. Parents health (Total score =36 points, pre-trial mean score = 23.8 points, post-trial means score = 30.4 points, a significant difference (P = 0.003)
10. Parents confidence in responding to how your child feels. (Total score =9 points, pre-trial mean score = 7.8 points, post-trial means score =8.8 with a significant difference of P = 0.008)

Table 5: CPQPL [15] - Child results of children aged 4-12 years.

Table 6: shows the means of CPQPL [15] - Child results before and after the trial

Discussion
The development of motor and sensory skills of CP Children is different from normal children [3]. CP Children should be treated early to improve balance and muscle spasms. The development of intervention and technology was recommended to help loosen the muscles, stretch the muscles and joints, maintain a normal posture, prevent joint symptoms and future complications [20]. This research started with problem- focused which led to the development of lycra garments and intervention testing after using the garment. Standardized and non-standardized assessment tools were implemented to measure the pre-and post-trial outcomes [9,11,16,18,19,20,21,22] such as gross motor function, clinical observation, satisfaction survey, customer acceptance questionnaire [12]. The familiarization period of 1 week allowed children to be prepared to wear the garment for a long period of time. The adjustment occurred after outcome measurement / post-intervention testing [16,12,20,21]. In this study, Functional Balance Grades and GMFM 66 were performed after wearing the garment for 6-8 hours per day for 6 weeks. The results showed improvement in sitting balance: able to sit upright (level 4) and maintain balance after wearing the bodysuit. The results are similar to those of related research that found bodysuits help to maintain balance. The bodysuit is an alternative to support therapy in children with CP [7] developed from Lycra (Dynamic splint) that fits the body. A muscular brace and posture support improve balance and movement for proper limbs, reduce symptoms of muscle stiffness and movement that are out of control. Correct the imbalance of the body and keep the posture in the correct position. Improved stability and walking performance [7,9,10,19]. A literature review [8,9] stated that balance in standing, sitting, walking, running, and comparing before and after wearing a suit were improved at a higher level. The difference is significant after wearing the bodysuit. In comparison with the control group [8,9] studied the effect of the garment on physical mobilities. A trial of 15 children with cerebral palsy who wore Lycra garments showed improvement not only in physical mobility but social skills and self-care too. Some studies [7] did not show any significant improvement in motor stability. Twenty-four patients aged 15 months to 14 years wore the garment for 4,3, and 6 weeks and assessed based on parental thoughts which showed no improvement by subjective video and measured by spirometry grip. According to the compliance [12] of CP, children found that four people left the study due to discomfort while wearing the suit. Four who completed the trial felt their balance was improved. In contrast, five patients who completed the trial were evaluated by an in-depth interview from parents or experienced specialists, then bodysuit was adjusted such as materials that heat dissipation suitable for people in Thailand, made from non-stiff fibres, lightweight makes the child feel comfortable, not constrained and a zippered pocket when the child goes to the toilet, giving them more freedom to go to the toilet and help themselves better. The child can wear a normal outfit over the bodysuit and live their normal lives. The materials for the garments were carefully selected to ensure that they will support the body, especially the sitting position.

Conclusion
Lycra garments were developed as a supportive device for children with cerebral palsy. The results of clinical assessment between the experimental and control groups were statistically significantly different. Functional Balance Grades and GMFM 66 results (sitting, supine, and rolling, walking, running, and jumping) were improved to a normal level. The satisfaction survey showed positive results particularly on ergonomics and aesthetic characteristics. Quality of life in all dimensions was higher after wearing the garment.

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