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临床试验/NCT05670522
NCT05670522已完成不适用

Transcranial Direct Current Stimulation Versus Virtual Reality on Gait in Children With Spastic Diplegia

Beni-Suef University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Gait velocity (m/s) (post-treatment)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • diagnosed with diplegic CP
  • the ages 7-12 years old
  • minimum spasticity grades of 1 and 1+ according to modified Ashworth Scale
  • Gross motor function classification system (GMFCS) at level I or II.
  • Independent ambulation without any assistance or with minimal assistance
  • A degree of cognition that allows understanding of the proposed procedures

排除标准

  • children who had visual impairments, hearing damage, fixed deformities at lower limbs,
  • History of orthopedic surgeries or injection with botulinum toxin in the previous year
  • Had metal implants in the skull
  • History of epilepsy or other neurological disorders
  • or inability to understand the task.

结局指标

主要结局

Gait velocity (m/s) (post-treatment)

时间窗: 2 weeks

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.

Gait velocity (m/s) (Pre-treatment)

时间窗: baseline

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.

Gait velocity (m/s) (Follow up)

时间窗: 10 weeks

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.

次要结局

  • Cadence (steps/min) (Pre-treatment)(Baseline)
  • Cadence (steps/min) (post-treatment)(2 weeks)
  • Stance time (s) (Pre-treatment)(Baseline)
  • Cadence (steps/min) (Follow up)(10 weeks)
  • Stance time (s) (post-treatment)(2 weeks)
  • Stance time (s) (Follow up)(10 weeks)
  • Swing time (s) (Pre-treatment)(Baseline)
  • Swing time (s) (post-treatment)(2 weeks)
  • Step length (cm) (Pre-treatment)(Baseline)
  • Stride length (cm) (post-treatment)(2 weeks)
  • Maximum force (kg) (post-treatment)(2 weeks)
  • Step length (cm) (Follow up)(10 weeks)
  • Maximum force (kg) (Pre-treatment)(Baseline)
  • Maximum peak pressure (N/cm²) (post-treatment)(2 weeks)
  • Swing time (s) (Follow up)(10 weeks)
  • Step length (cm) (post-treatment)(2 weeks)
  • Stride length (cm) (Follow up)(10 weeks)
  • Stride length (cm) (Pre-treatment)(Baseline)
  • Maximum peak pressure (N/cm²) (Follow up)(10 weeks)
  • Maximum force (kg) (Follow up)(10 weeks)
  • Maximum peak pressure (N/cm²) (Pre-treatment)(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Radwan

Assistant lecturer

Beni-Suef University

研究点 (2)

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