Design
The Ethics Committee of the Umm Al-Qura University approved this randomized controlled trial (HAPO-02-K-012-2020-12-516). Parents have completed a consent form allowing their children to participate in the research. The children who participated were chosen from the Physical Therapy Department, Maternity and Children Hospital, Makkah, Saudi Arabia. This trial was registered in ClinicalTrial.gov PRS No. NCT05020834.
Participants, therapists, and centers
To evaluate age, diagnosis, and inclusion and exclusion criteria, forty children with hemiplegic CP were first examined and assessed. The following were the criteria for inclusion: magnetic resonance imaging (MRI) was used to confirm the diagnosis of hemiplegic CP in the children who participated in this study. Both sexes are between the ages of 8 and 12. The level of spasticity in the lower limbs ranged from grade 1 to grade 2 on the modified Ashworth scale (MAS). The levels of motor function were between levels I and II, according to the Gross Motor Function Classification System (GMFCS). The children in concern were cognitively capable of comprehending and following directions. They had no major medical issues, according to their medical report. Skin diseases and allergic reactions to the adhesive tape used in this study were excluded, as were any deformities that interfered with lower limb functions, children with pacemakers who were contraindicated by electrical stimulation, children with visual, auditory, or perceptual deficits, children with seizures, and children who had received botulinum toxin or other spasticity medication. Demographic (i.e., age and sex) and clinical (i.e., side of hemiplegia and GMFCS levels) information was collected in order to describe the sample. Therapists were included in the study once they were familiar with the FES and TheraTogs. Centers were included in the study if they were well equipped and specialized in pediatric rehabilitation.
Randomization
Thirty children with hemiplegic CP met the above-mentioned criteria after the screening process. Children were randomly allocated, using a random number generator, with the allocation to either the FES or TheraTogs group being concealed. The random numbers were generated by the receptionist with every alternate number being marked either 1 or 2. However, the receptionist was blinded to the interventions assigned to group 1 (FES group) and group 2 (TheraTogs group). During allocation, every subject was asked to pick up one enclosed envelope from a box containing numbers from 1 to 30. Depending on the number picked by the subject, they were allocated to either group 1 or group 2 by the receptionist. Therefore, two groups of 15 patients each were created with an aim to minimize the risk of allocation bias. All the patients were evaluated at baseline and after 3 months of treatment by the same therapist, who was blinded to the allocation of patients to the FES or TheraTogs group. Group 1 (FES group) received traditional physical treatment as well as FES, while group 2 (TheraTogs group) received TheraTogs as well as traditional physical therapy. The experimental design of this study is shown in Fig. 1.
Gait parameters evaluation
The same examiner used the Pro-Reflex motion analysis (Qualisys; Qualisys Inc., Goeteborg, Sweden) to analyze all children’s gait parameters before treatment and after 3 months of treatment. An 8-m-long wooden walkway, a three-dimensional infrared camera system with six cameras evenly positioned on both sides of the walkway, and a personal computer with Q-Trace software installed to analyze the motion pattern comprise this system. Reflective markers with a diameter of 9 mm are included in this system to help users fine-tune the camera’s focus settings. The superior border of the patella, laterally at the knee joint line, tibial tuberosity, lateral malleolus, heel posterior to the calcaneus, and between the second and third metatarsal heads were all marked bilaterally. The calibration, data capture, and analysis procedures were carried out in accordance with the motion system’s manual. Velocity (m/s), stride length (m), cadence (steps/min), cycle time (s), and percent of time spent in stance of the affected limb (%) were the gait parameters that were analyzed [21, 22].
Postural stability evaluation
The same examiner, who was blinded to the children’s assignment, tested all of the children for postural stability before therapy (pre-treatment) and after 3 months of treatment (post-treatment). The Biodex balance system (Balance System SD, Shirely, NY) was used to assess postural stability. It measures the capacity to maintain postural stability on an unsteady surface and is used to test neuromuscular control [23]. A high-resolution color touch screen, support rails, and 12 platform control levels are included in the Biodex. It has a total of 12 levels of stability (12 is more stable and 1 is less stable).
During the assessment, children were asked to maintain a centered position on a slightly unstable surface by shifting their feet until they could easily keep a cursor centered on a screen while standing. The child was then instructed to keep his or her foot in place until the platform was stable. After the foot angles and heel coordinates were entered into the system, the test started. The child was instructed to keep their eyes focused on the visual feedback screen directly in front of them, to keep both arms at their sides without grasping the handrails, and to keep the cursor in the middle of the screen’s bull’s eye. The test lasted 30 s and was determined as the average of three tests. The results were printed once the test was completed. The overall stability index, anterior-posterior stability index, and medio-lateral stability index were all included in the results. These results with higher values indicate balance problems [24].
Interventions
Traditional physical therapy program
Both groups of children received a traditional physical therapy program that included neuro-developmental treatment for both lower limbs, stretching exercises for tight hip flexors and adductors, knee flexors, and ankle plantar flexors, strengthening exercises for the trunk and both lower limbs, proprioceptive training, balance exercises in all directions from a standing position, and gait training in a closed and open environment, for three consecutive months (1 h/day, 3 days/week) [25].
FES treatment
The WalkAide stimulator (Innovative Neurotronics, Austin, Texas, USA) was used to administer FES to the children in the FES group. During the swing phase, WalkAide FES has one channel with two electrodes that are adhesively placed on the peroneal nerve to trigger dorsiflexors. The device is powered by a single AA battery and includes a tilt sensor, accelerometer, and inclinometer to detect the rate and angle of the lower leg and initiate stimulation of the peroneal nerve, which generates an action potential that stimulates the dorsiflexors during the swing phase, reducing foot slapping and producing a normal gait pattern.
To stimulate the peroneal nerve before its separation into superficial and deep branches, the active electrode was placed inferior and behind the head of the fibula. The therapist performed small changes to the electrode placement to activate the tibialis anterior muscle more selectively. The electrode sensor was then inserted inside the device cuff to eliminate any bias in electrode position every time the device was worn. To complete the circuit, the passive electrode was inserted over the belly of the tibialis anterior muscle. The intensity of the WalkAide system’s asymmetrical biphasic electrical current was gradually increased in order to get the best contraction of the tibialis anterior muscle while remaining within the child’s tolerance.
The software was saved on the device once the proper timing was determined, ensuring that the stimulation was continuously delivered and ended at a specific shank angle. The pulse width has been set to a maximum of 300 μs, and the frequency has been set to a maximum of 33 Hz. With a dial on the WalkAide device, a therapist can adjust the intensity (mA). This device kept track of operation times as well as the total number of stimulations. Electrodes should be changed every 2–3 weeks for proper care and maximum efficiency. A permanent marker was used to mark the position of the cuff and electrodes on the leg. Children were required to utilize WalkAide for 2 h per day as massed practice, 3 days per week, for 3 months during FES therapy [26,27,28].
TheraTogs orthotic treatment
A sleeveless top vest and two shorts with two thigh cuffs and limb cuffs each make up the TheraTogs strapping system which applied to the children in the TheraTogs group. The TheraTogs suit was worn directly over the skin under the garments, providing breathable, comfortable Latex over the torso and thigh, as well as unrestricted toileting. For infection control and size fitting problems, participants were not allowed to share their TheraTogs with other patients [29].
TheraTogs were applied in two stages: the top vest or hipster fit and the strapping technique. First, the top vest was properly adjusted while the patient was upright, ensuring that there were no constrictions, comfort, or circulation difficulties. This top fitting provides the patient with constant exteroceptive and proprioceptive feeling, allowing the patient to recover core stability and adequate postural orientation, providing the patient with the necessary stability and safety. With the patient in the starting position with the hip in 5° abduction and external rotation, the hip abduction strapping system was applied. A wide strap was then fastened to the lower back of the affected thigh cuff and drawn up inner to and in front of the thigh, the hip joint, into the sacral region, and attached to the non-affected side’s torso. The top two straps supported the top vest in front and back panels, the lower two straps were attached to the thigh cuffs to resist hip adduction while providing vertical trunk firmness, and on the outer thigh, the thigh cuff straps were moved closer together, and all straps were modified in length and position to get the desired effect [19, 29].
The wearing schedule of TheraTogs for this study was adapted from our previous research on children with CP [20]. TheraTogs orthotic undergarment and strapping system were worn under their regular clothes, so it was neither distracting nor irritating. The participating children wore their TheraTogs as a preparation stage without any exercise program for 1 week before starting the training program, gradually increasing the worn time till reaching 2 h per day to allow the children to become acclimated to the system [20].
Statistical analysis
A preliminary power analysis (power = 0.8, α = 0.05, effect size = 0.5) was performed to avoid a type II error, resulting in a sample size of 30 for this study. The sample size was calculated using G Power version 3.1 (Heinrich- Heine-Universität, Düsseldorf, Germany).
The results were expressed as mean and standard deviation (SD). Our data were normally distributed which was tested by Shapiro-Wilk test, so the mean values of all measured parameters, comparison of assessments before and immediately after the treatment in each group was performed using paired t-test, whereas the comparison of assessments between both groups before and immediately after treatment was carried out using an unpaired t test. The level of significance was set at alpha < 0.05. Statistical analysis was performed using SPSS software version 20 (SPSS Inc., IBM, Chicago, IL, USA).