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临床试验/NCT07390760
NCT07390760招募中不适用

Effects of Remote Ischemic Conditioning (RIC) Combined With Balance Training on Spinal Reflex Modulation in Children With Cerebral Palsy

East Carolina University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年7月28日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
16
试验地点
1
主要终点
Change in maximal H-reflex amplitude (Hmax)

研究概览

简要总结

Remote ischemic conditioning (RIC) is a clinically feasible intervention involving brief, sublethal periods of ischemia followed by reperfusion that has been shown to enhance motor performance, strength, and balance when combined with training in healthy adults and individuals with neurological conditions. Although RIC is thought to influence neuroplasticity through neural, metabolic, and humoral pathways, its effects on spinal-level mechanisms remain poorly understood. Emerging evidence indicates that neuroplastic adaptations occur not only at the cortical level but also within the spinal cord. Moreover, altered spinal reflex excitability is associated with spasticity, balance impairments, and functional limitations in children with cerebral palsy (CP), yet the role of spinal reflex modulations in response to RIC and balance training remains under expplored in this population. Therefore, this study aims to investigate the effects of RIC combined with balance training on spinal reflex modulation in children with CP.

详细描述

Remote ischemic conditioning (RIC) is a clinically feasible, non-invasive intervention that involves brief, sublethal periods of ischemia followed by reperfusion and has been shown to improve motor performance, strength, and balance when combined with training in healthy adults and individuals with neurological conditions. Evidence from animal and human studies suggests that RIC exerts neuroprotective effects through multifactorial mechanisms involving neural, metabolic, vascular, and humoral pathways, with emerging data indicating the involvement of peripheral and spinal pathways. Neuroplasticity in response to training is known to occur not only at the cortical level but also within spinal neural circuits, where altered spinal reflex excitability is associated with spasticity, balance impairments, and poor functional outcomes in children with cerebral palsy (CP). While balance and locomotor training have been shown to reduce spinal reflex excitability in this population, the effects of RIC on spinal reflex modulation remain largely unexplored. The specific aims of this study are to determine whether 1) RIC combined with balance training modulates spinal reflex excitability, as reflected by H-reflex measures, and 2) to examine whether RIC combined with balance training leads to greater improvements in balance performance compared to sham conditioning combined with training in children with CP.

In this study, 16 children with cerebral palsy (ages 8-17 years) will be recruited. They will be randomly allocated into two groups: (A) RIC and (B) Sham. The study will consist of five consecutive visits. During Visit 1, participants will undergo baseline testing of the soleus H-reflex using a DS8R stimulator. After baseline testing, they will complete the first training session, which will include one session of conditioning combined with balance training (15 trials per session) on a stability trainer (Lafayette, IN). Visits 2 to 5 will each consist of one session of conditioning and balance training (second to fifth training sessions). During Visit 5, following the training session, post-testing of the H-reflex will be conducted. The average of the first five trials of balance training on Visit 1 will be used as the pre-test balance performance, and the average of the last five trials of balance training on Visit 5 will be used as the post-test balance performance. Conditioning will be administered to the more affected lower extremity (thigh), and a pulse oximeter will be placed on the toe for monitoring.

It is hypothesized that, compared to sham conditioning, remote ischemic conditioning combined with balance training will result in greater reductions in H-reflex excitability and greater improvements in balance performance in children with cerebral palsy. This study will help clarify whether RIC induces spinal reflex modulations when paired with balance training, reflecting spinal-level neuroplasticity in children with CP. These findings may advance understanding of the spinal mechanisms underlying the therapeutic benefits of RIC and support its translation as an adjunct intervention in pediatric neurorehabilitation.

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
Single (Participant)

盲法说明

Participants are masked to group assignment (RLIC vs. Sham conditioning)

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children diagnosed with cerebral palsy (CP) between the ages 8-17 years
  • Gross motor function classification system levels I-III
  • Mainstream in school and has sufficient cognition to follow the experiment instructions

排除标准

  • Children with other developmental disabilities such as autism and developmental coordination disorders
  • Children with cognitive deficits such as inability to understand and follow commands, substantially lower performance at grade level in school, and/or communication problems
  • Children with balance disorders such as vestibular disorders, posterior fossa tumor etc.
  • Children with known cardiorespiratory dysfunctions
  • Children with sickle cell disease
  • Children who are receiving other adjunct therapies such as transcranial magnetic stimulation, transcranial direct current stimulation, or vagal nerve stimulation
  • Presence of lower extremity condition, injury, or surgery within last three months which could compromise conditioning and training.
  • Participants who are pregnant.

研究组 & 干预措施

Remote Ischemic Conditioning (RIC)

Experimental

RIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 200 mmHg on the thigh of more affected lower extremity. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 1 - 5.

干预措施: Remote Ischemic Condtioning (RIC) (Behavioral)

Remote Ischemic Conditioning (RIC)

Experimental

RIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 200 mmHg on the thigh of more affected lower extremity. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 1 - 5.

干预措施: Sham conditioning (Behavioral)

Sham conditioning

Sham Comparator

Sham conditioning is achieved via blood pressure cuff inflation to 25 mm Hg on the thigh of the more affected LE. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 1-5.

干预措施: Sham conditioning (Behavioral)

Sham conditioning

Sham Comparator

Sham conditioning is achieved via blood pressure cuff inflation to 25 mm Hg on the thigh of the more affected LE. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 1-5.

干预措施: Balance training (Behavioral)

结局指标

主要结局

Change in maximal H-reflex amplitude (Hmax)

时间窗: [Time Frame: Baseline, Day 5]

The maximal (peak) H-reflex amplitude will be determined from the recruitment (stimulus-response) curve. The Hmax amplitude provides an estimate of the number or proportion of motor neurons (MNs) activated from the total MN pool, reflecting spinal reflex modulations and spinal neuroplasticity.

Change in Hmax/ Mmax Ratio

时间窗: [Time Frame: Baseline, Day 5]

The maximal H-reflex and maximal M-wave amplitudes will be determined from the recruitment curve procedure. Calculating the Hmax/Mmax ratio is a standardization method used to reduce variability in H-reflex amplitude across participants. This provides a better basis for comparison and a more reliable estimate of changes in spinal reflex modulations between participants.

次要结局

  • Change in Balance Performance([Time Frame: Baseline, Day 5])

研究者

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

Swati Manoharrao Surkar

Assistant Professor

East Carolina University

研究点 (1)

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