Design
The research design of this study was a randomized control trial. It was approved by the Ethics Review Committee of the Faculty of Applied Medical Sciences - Umm Al Qura University. This trial was registered in the ClinicalTrial.gov PRS (NCT05063175). Children’s parents signed consent for permitting the engagement of their children in this study. The study was proceeded according to the Declaration of Helsinki of 1975, as revised in 2013.
The study was conducted in the Department of Physical Therapy - Umm Al Qura University. The involved children were recruited from the kingdom of Saudi Arabia - the western region. The organization responsible for the integrity, conduct, and financial support of this study was the Deanship of Scientific Research at Umm Al Qura University - Grand Code (19-MED-1-01-0005).
Participants
Children of both sexes with a confirmed diagnosis of spastic diplegic cerebral palsy were selected to participate in this study. These children were between 8 and 10 years old. The degree of spasticity in the affected upper and lower extremity, based on the Modified Ashworth Scale (MAS), ranged between grades 1, 1+, and 2.
Children were able to comprehend and follow orders. Their gross motor development levels, as measured by Gross Motor Function Classification System (GMFCS), were between levels (I and II), and they had the ability to stand alone for 5 to 10 min without any assistance. So that, they were able to perform the pre and post-treatment evaluation procedures. The spinal kyphosis, for all participating children, was flexible. The degree of Cobb’s angle was not more than 45°. This is because if the degree of kyphosis is above 55°, it is considered as fixed hyper-kyphosis; however, kyphosis below this range is flexible and it could be improved by conservative treatment such as exercising or bracing [14, 15]. Throughout the study period, the participating children were not subjected to any other physical therapy programs except the assigned treatment protocol.
The children were excluded from this study if they had fixed spinal deformities or corrective surgeries interfering with spinal mobility. Children who have a skin allergy to the materials from which the TheraTogs was fabricated have been also excluded. Children who had seizures, perceptual disorders, visual problems, and auditory deficits have not participated as well.
The sample size of this study was calculated based on a preliminary power analysis (power = 0.8, α = 0.05, effect size = 0.5, groups = 2, and evaluation times = 2). A total sample size of 40 participants was calculated for this study. The participating children were divided equally into two groups. The randomization process was performed by an independent person who was blinded to the study procedures. It was performed simply by adding a specific identification number for each participating child. SPSS program was used to randomly assign children to both groups.
Assessment
Assessments of the children with diplegic cerebral palsy were conducted by evaluators who did not participate in the application of intervention and were also blinded from the randomization process. The evaluation was carried out to measure the changes in the mean scores of the following primary and secondary outcome measures from pre to post-treatment; primary outcome measures included (1) the thoracic kyphosis angle (°) and (2) thoracic flexion and extension range of motion (degree), while the secondary outcome measures included (3) the overall stability index of the fall risk test (%) and (4) the Pediatric Balance Scale score.
DIERS Formetric 3D/4D spine and posture analysis system. It is a light-optical scanning technique that depends on video-raster-stereography (VRS). It is a special device for contactless, quick, and radiation-free dynamic and static evaluation of the spine. The DIERS formetric supplies a comprehensive report about the statics and the posture of the entire spine in only one evaluating process. In this study, it was used for measuring the sagittal geometry of the back surface of the participating children according to a contactless 3D scan.
Formetric 3D/4D spine and posture analysis system is valid and reliable equipment for measuring lateral and frontal spinal curves, the rotation of vertebrae, and the pelvic deviations [16]. Thoracic kyphotic angle for each child was calculated from the sagittal profile by formetric system: Kyphotic angle measured between vertebral prominence (VP) and the estimated location of the 12th thoracic vertebra (T12).
Spinal mouse, a computerized spinal assessment device, was used for measuring the spinal flexion and extension range of motion (ROM) in a non-invasive way. It is a reliable and valid device for evaluating spinal intersegmental mobility [17]. Measurements were recorded while the children stood bare-back and the evaluator moved the spinal mouse along their spinal columns from 7th cervical vertebra to the rima ani (3rd sacral vertebra). The evaluation was performed from the following three successive spinal positions: (1) upright erect, (2) maximal flexion, and (3) maximal extension.
Biodex Balance System SD (BBS; Biodex Inc., Shirley, NY) was utilized as a reliable and valid device for measuring the stability indices of the Risk of Fall test from standing position at dynamic mode (12) of platform tilt [18]. The Biodex system has a static mode and 12 levels of dynamic platform tilt {level (12) with greatest stability, while level (1) with the least stability}.
The dynamic level 12 was selected, in this study, for conducting the fall risk test. The recorded result for every participant was automatically saved and was compared to the normative values stored in the equipment according to their age. The closer the score that was recorded to the typical score, stored in the equipment software, the lower the risk of fall. On the contrary, the higher the score than that stored, the greater the risk of fall which indicated poor balance performance.
The Pediatric Balance Scale (PBS) is a valid and reliable test to assess and re-assess balance deficits in children with mild and moderate motor disabilities. The test includes fourteen tasks that evaluate balance abilities and motor performance in children. The rating score for each item is ranged from 0 to 4, where 0 is the lowest score and 56 is the highest possible score for all tasks that indicates the best balance and motor performance [19].
Interventions
Both groups (control and study) received the conventional physical therapy protocol aiming for modulating thoracic kyphotic posture and improving the axial postural alignment. The conventional exercise protocol for both groups is fully outlined in Additional file 1: Appendix 1.
The conventional therapeutic protocol for every child was 3 sessions/week for 12 consecutive weeks. It was applied by two qualified physical therapists. Every treatment session was conducted for 2 h with a 15-min rest between the two training hours. Materials used in the application of conventional physical therapy treatment included therapeutic mats, balls, wedges, rolls, parallel bars, treadmills, steppers, balance boards, and Bobath beds.
The children in the study group received the conventional protocol given to the control group. Moreover, they wore TheraTogs orthotic undergarment with the strapping system 8 h every day for the 12 consecutive weeks. For every participating child, TheraTogs was applied after appropriate and accurate pre-treatment evaluation. Application and fitting of TheraTogs and strapping protocol was applied by a qualified physical therapist who was certified on TheraTogs fitting.
A TheraTogs orthotic undergarment developed by Cusick [20] is composed of a sleeveless Tank-Top (vest), two shorts (Hipster) each with two thigh and limb cuffs. They are designed to be worn directly on the skin as undergarments that allow unobstructed toileting. A well-fitted TheraTogs system provides the wearer a vertical compression and stiffness to support posture, and reinforce stability.
Each child had his/her own TheraTogs orthotic undergarment. It was not allowed for any child to share his/her orthosis with others for two reasons: (1) to avoid any infectious disease transfer and (2) every child had its special size, which might not fit with others. In this study, the participating children wore the TheraTogs and strapping system under their regular dresses, so it was not annoying or disturbing.
A preparatory course for (14 days) before starting the treatment program was given to all participating children to become accustomed to wearing the TheraTogs orthotic undergarment and strapping system. The wearing period gradually increased from 1 h at the beginning of the course until reached the 8 h that were planned in this study.
Throughout this course, the therapist who is responsible for the TheraTogs protocol trained one of the child’s family members on (1) how to fit the TheraTogs orthosis to his/her child, and (2) how to apply the prescribed strapping technique for the involved body parts. By the end of this course, the therapist made sure of the skills of this member in the application of the TheraTogs protocol before the actual beginning of the treatment program.
It was not allowed to start the treatment program with TheraTogs until making sure of the family member’s skill and proficiency in providing the prescribed TheraTogs protocol. Any member who was not successful in this preparatory course was retrained again. The therapist daily followed up the process of wearing TheraTogs and strapping by telephone with this member and made sure that the process was completed successfully. This daily communication continued throughout the treatment period (12 weeks).
The fitting and strapping techniques of TheraTogs system for all participating children in the study group are fully outlined in Additional file 2: Appendix 2.
Statistical analysis
The statistical analysis for all recorded scores pre- and post-treatment was reported as mean ± standard deviation (SD). The Shapiro-Wilk test and the Levine's test were used to test the variables’ normal distribution and variances homogeneity, respectively. The data of this study were homogeneous and normally distributed. Paired t test was used to compare the changes within both groups, pre-and immediately post-treatment. While the comparison between both groups was carried out by using unpaired t test. Recorded data were analyzed by using SPSS computer program version 25.00. P values less than 0.05 were accepted to represent a statistical significance.
