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临床试验/NCT07342660
NCT07342660已完成不适用

The Therapeutic Effect of Transcranial Direct Current Stimulation and Treadmill in Children With Cerebral Palsy

University of Sharjah1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年7月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
Gait speed

研究概览

简要总结

Background: Cerebral Palsy (CP) is characterized by altered excitability in bilateral sensorimotor cortical areas. Previous research using unilateral anodal transcranial direct current stimulation (tDCS) has yielded inconsistent results, highlighting a need for alternative stimulation approaches.

Objective: This study evaluated the feasibility, safety, and preliminary efficacy of combining bilateral anodal transcranial direct current stimulation (tDCS) over the sensorimotor cortices with treadmill training in children with CP.

Methods: A within-subjects case series was conducted with five children with CP. Participants received ten sessions of treadmill training (at 50% of their maximum over-ground speed) concurrently with bilateral anodal tDCS. Outcomes, assessed pre- and post-intervention, included postural alignment (medio-lateral and anterior-posterior), ankle dorsiflexion range of motion, gait variability, walking tolerance (6-minute walk test), motor function (GMFM-66), and hip/knee range of motion. Statistical analysis was performed using paired t-tests and effect sizes (Hedges' g).

Anticipated Impact: This study will pioneer a novel bilateral tDCS montage for CP rehabilitation. The findings are expected to provide critical insights into the synergistic relationship between neuromodulation and physical training, ultimately informing more effective, evidence-based interventions to enhance motor function and participation in this population.

详细描述

Introduction Motor control and coordination in pediatric cerebral palsy patients have been improved through various methods. Treadmill training demonstrates efficacy in enhancing gait velocity, balance, and functional independence. Furthermore, transcranial direct current stimulation (tDCS) presents a non-invasive and safe alternative to surgical or pharmacological treatments. Collectively, these interventions have proven effective in advancing gait performance and functional capabilities in this population.

The optimal protocol for administering tDCS to pediatric cerebral palsy patients has yet to be established. Contrary to earlier studies that utilized unilateral anodal stimulation targeting the contralateral motor cortex, a hypothesis suggests that bilateral stimulation of both hemispheres could yield superior outcomes. This premise is supported by magnetoencephalography (MEG) a widespread disruption in neural excitability within both sensory-motor cortices of children with CP. This bilateral impairment occurs even in cases of unilateral lesions and contributes to reduced activation in corticospinal pathways. Accordingly, subsequent research applying unilateral anodal tDCS to the ipsilateral motor cortex (non-lesioned hemisphere) demonstrated enhancements in motor functions such as reaching skills and movement duration.

As a feasibility study, this pilot research assessed the practicality and initial effects of administering bilateral anodal tDCS concurrently with treadmill training to enhance gait parameters, range of motion, and reduce spasticity in pediatric patients with diplegic CP.

Methods Study design & participants This clinical study was approved by the IRB committee of Jordan University of Science and Technology and the King Abdullah University Hospital (#2019/420) based on the Declaration of Helsinki. Five children (aged 4-12 years) with spastic diplegic CP were enrolled. Inclusion criteria stipulated a Gross Motor Function Classification System (GMFCS) level of I-III, the ability to walk independently for at least 10 meters, and an IQ greater than 70. Key exclusion criteria included a history of orthopedic surgery, neurolytic blocks, or Botox injections in the past six months, as well as the presence of concurrent orthopedic impairments, epilepsy, intracranial metal implants, or hearing aids. In addition, voluntary written informed consent was obtained from all participant children by their legal guardians before participation in the study.

Treadmill training & tDCS intervention While prior research utilizing unilateral anodal tDCS in children with CP positioned a single anode over the C3 or C4 motor cortex and a cathode on the supra-orbital area according to the 10-20 EEG system, the present study employed a bilateral montage. Using the 10-10 EEG system for more precise placement, two anodes were positioned over the left FC1 and right FC2 regions (encompassing motor and frontal areas), with two corresponding cathodes located over the bilateral supra-orbital areas. A low current intensity of 1mA was applied.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Gross Motor Function Classification System (GMFCS) level of I-III
  • ability to walk independently for at least 10 meters
  • IQ greater than 70

排除标准

  • history of orthopedic surgery
  • history of neurolytic blocks,
  • history of Botox injections in the past six months
  • Presence of concurrent orthopedic impairments
  • Presence of epilepsy
  • Presence of intracranial metal implants

结局指标

主要结局

Gait speed

时间窗: Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

Gait speed (meters/second)

Gait variability

时间窗: Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

Gait variability (dimensionless autocorrelation coefficient)

Walking endurance

时间窗: Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

Walking endurance assessed using the 6-Minute Walk Test (distance in meters walked within 6 minutes intervals)

Developmental Motor function

时间窗: Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

Gross motor function measure - Item set scale (Total Score, Higher score good motor function development, lower score poor motor function development)

Postural Alignment

时间窗: Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

Postural alignment (medio-lateral displacement in cm) Postural alignment (anterior-posterior displacement in cm)

次要结局

  • Spasticity(Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline))
  • Joint Range of Motion(Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline))

研究者

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

Hikmat Hadoush

Dr. / Associate professor

University of Sharjah

研究点 (1)

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