An interventional study of Transcranial direct current stimulation and Virtual reality in Cerebral Palsy, sponsored by Beni-Suef University. Completed at 1 site in Egypt. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment
Spastic diplegia is the most frequent type of cerebral palsy (CP), and impaired gait is a common sequela of this condition. The investigators compared the effects of two novel research interventions transcranial direct current stimulation (tDCS) and virtual reality (VR) on gait impairments in children with spastic diplegia.
Currently, both tDCS and VR require further investigation to determine their clinical effectiveness for children with CP. Thus, the aim of this study was to compare the effects of tDCS and VR training on spatiotemporal and kinetic gait parameters in children with spastic diplegia, as a supplemental intervention to traditional physical therapy.
Cerebral palsy (CP) is caused by early-stage brain injury, affecting 2 to 3 children in every 1000 live births. CP is divided into different subtypes depending on the dominant neurological signs: spastic, dyskinetic, or ataxic. Epilepsy and intellectual disability, as well as problems with speech, hearing, and vision, are all common complications [1]. spastic diplegic CP is one of the most common developmental disabilities throughout life, caused by large-scale changes in subcortical brain activity with a reduced activation of corticospinal and somatosensory circuits, which leads to diminished activation of the central nervous system during volitional activities.
Gait impairment is seen in 90% of children with spastic diplegic CP, stemming from this decreased cortical excitability and compounded by spasticity of the lower extremities, excessive muscular weakness, impaired joint mobility, and poor coordination and balance. Specifically, children with CP have reduced gait velocity, cadence, and stride length, among other affected spatiotemporal gait parameters. The International Classification of Functioning Disability and Health consider changes in the spatial and temporal characteristics of gait to be important predictors to poor function and community participation. Additionally, crouched gait, scissoring, and other atypical gait patterns are common in this population, further affecting the kinematic and kinetic characteristics of gait and leading to metabolically expensive locomotion, high fall risk, and long-term musculoskeletal injury. For children with spastic diplegic CP, the primary goal of rehabilitation is to facilitate mobility and appropriate walking patterns with or without external assistance. Improving spatiotemporal and kinetic characteristics of gait would improve gait function, increase gait efficiency, and reduce the risk of long-term disability. In turn, it would allow these children to participate in more activities of daily living, meaningful interactions with family and society, and environmental exploration, as well as to improve their physical development.
In the current study, the investigators considered two technology-driven strategies that could potentially target gait impairments and improve gait function in children with CP: virtual reality (VR) and transcranial direct current stimulation (tDCS). Both interventions have been studied for their therapeutic potential with mixed results, especially in children. Specifically, VR can simulate real-life activities while providing repetition, augmented sensory input and feedback, error reduction/augmentation to increase motivation during the rehabilitation process. As a training tool, VR provides visual perceptual stimulation resulting from dynamic changes in context, which may aid in the execution of regulated exercises while also requiring concentration and additional postural control. Neuroimaging studies suggest that VR can facilitate learning and recovery by stimulating cortical reorganization and neural plasticity. Previous research has utilized VR as a therapeutic tool for children to improve balance, walking speed, and/or distance, as well as to encourage physical activity. Additional VR therapies have been shown to enhance functional performance in activities including squatting, standing posture, and energy expenditure. With the commercialization of VR-related products like the Nintendo Wii, many virtual games are readily available for home use. These games are often designed to challenge and train balance, posture, and dynamic movements all of which are critical factors for gait. Thus, VR-based rehabilitation may offer a unique, accessible therapeutic approach to reduce gait impairments and improve dynamic function.
In contrast, tDCS is a neuromodulation technique focused on optimizing existing neural pathways to prolong and/or improve the functional gains achieved by rehabilitation. tDCS is applied through either anodal or cathodal stimulation, which corresponds to excitation or inhibition of the stimulated brain areas, respectively. Anodal stimulation enhances cortical excitability through depolarization, allowing for more spontaneous cell firing, while cathodal stimulation has an inhibitory effect through hyperpolarization. Functionally, this means application of tDCS will influence activity in the area of the brain it targets. Previous research indicates that inhibited cortical input to the corticospinal tract is a possible cause of increased spasticity in CP, so it is reasonable to predict that anodal stimulation would mitigate these symptoms in individuals with spastic CP. The neurophysiological effects of anodal tDCS can also potentiate motor learning through this increase in cortical activity, which is applicable to the treatment of all subtypes of CP. These benefits may translate into functionally improved gait as well.
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Children assigned to the transcranial direct current stimulation group received active transcranial direct current at their primary motor cortex (Active dose 11, ser. No 13070350, Active Tek Inc., USA). Stimulation was conducted at an intensity of 1 mA for 20 min per session, 5 times/week for 2 successive weeks (total of 10 sessions). 1 mA was shown to be appropriate in children's investigations. The anode (+) was positioned on the midline sagittal plane of the skull, corresponding to the motor area of lower limbs, and the cathode (-) was positioned over the inion. In addition to their assigned intervention, the children received the standard-of-care gait training. During the two-week intervention phase, gait training was administered immediately after each intervention session. Training was delivered in one hour increments 5 times/week for those first two weeks, then 3 times/week for the next 10 weeks.
Device: Transcranial direct current stimulation
Children assigned to the virtual reality group received virtual balance training using Nintendo Wii and Wii Balance Board, with a custom training program developed from activities on the Wii Fit Plus game. Training was conducted for 30 minutes, 5 sessions/week for 2 successive weeks (total of 10 sessions). Two sessions with Wii Fit Plus were conducted before the treatment protocol to help the children familiarize with the VR setup. In addition to their assigned intervention, the children received the standard-of-care gait training. During the two-week intervention phase, gait training was administered immediately after each intervention session. Training was delivered in one hour increments 5 times/week for those first two weeks, then 3 times/week for the next 10 weeks.
Device: Virtual reality
Transcranial direct-current stimulation (tDCS), over the motor cortex, is a potential therapy option for motor control deficits in children with CP. The application of tDCS involves positioning 2 rubber electrodes sheathed in saline-soaked pads onto the scalp, held in place by a rubber strap. Low-intensity, direct-current, of 1 to 2 mA, is delivered to cortical areas from the device. The standard-of-care gait training included various gait training and balance tasks as well as resistive exercises and passive stretching as necessary. Task-specific gait exercises included: walking in a closed indoor environment, walking in an open indoor environment, walking on various floor surfaces, and climbing stairs up and down without assistance. The children also performed dynamic balance exercises by walking on a balance board.
Virtual reality rehabilitation is an emerging therapy for motor rehabilitation of children with CP. The therapy is provided through a computer-simulated environment where they interact with real-world-like objects and events through sight, sound, and touch. The Wii Remote was used as the interactive interface, and standard computer/television screens were used as the display hardware. Therefore, VR therapy was of the non-immersive type. The standard-of-care gait training included various gait training and balance tasks as well as resistive exercises and passive stretching as necessary. Task-specific gait exercises included: walking in a closed indoor environment, walking in an open indoor environment, walking on various floor surfaces, and climbing stairs up and down without assistance. The children also performed dynamic balance exercises by walking on a balance board.
Gait velocity (m/s) (Pre-treatment)
Gait velocity was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with the soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: baseline
Gait velocity (m/s) (post-treatment)
Gait velocity was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with the soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 2 weeks
Gait velocity (m/s) (Follow up)
Gait velocity was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with the soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 10 weeks
Cadence (steps/min) (Pre-treatment)
Cadence was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: Baseline
Cadence (steps/min) (post-treatment)
Cadence was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 2 weeks
Cadence (steps/min) (Follow up)
Cadence was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 10 weeks
Stance time (s) (Pre-treatment)
Stance time was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: Baseline
Stance time (s) (post-treatment)
Stance time was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 2 weeks
Stance time (s) (Follow up)
Stance time was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 10 weeks
Swing time (s) (Pre-treatment)
Swing time was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: Baseline
Swing time (s) (post-treatment)
Swing time was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 2 weeks
Swing time (s) (Follow up)
Swing time was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 10 weeks
Step length (cm) (Pre-treatment)
Step length was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: Baseline
Step length (cm) (post-treatment)
Step length was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 2 weeks
Step length (cm) (Follow up)
Step length was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 10 weeks
Stride length (cm) (Pre-treatment)
Stride length was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: Baseline
Stride length (cm) (post-treatment)
Stride length was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 2 weeks
Stride length (cm) (Follow up)
Stride length was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 10 weeks
Maximum force (kg) (Pre-treatment)
Maximum force was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: Baseline
Maximum force (kg) (post-treatment)
Maximum force was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 2 weeks
Maximum force (kg) (Follow up)
Maximum force was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 10 weeks
Maximum peak pressure (N/cm²) (Pre-treatment)
Maximum peak pressure was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with the soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: Baseline
Maximum peak pressure (N/cm²) (post-treatment)
Maximum peak pressure was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 2 weeks
Maximum peak pressure (N/cm²) (Follow up)
Maximum peak pressure was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis.
Time frame: 10 weeks
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