The Effect of Spinal Manipulation on Heart Rate Variability in Children With Cerebral Palsy. Randomised Comtrolled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Root Mean Square of Successive Differences (RMSSD)
研究概览
简要总结
This randomized, sham-controlled crossover trial aims to evaluate the immediate effects of spinal manipulation on heart rate variability in children with cerebral palsy. Each participant will attend four experimental sessions conducted on separate days. In two sessions, spinal manipulation will be performed, and in two sessions, a sham procedure will be applied. The order of interventions will be randomized for each participant. Heart rate variability will be recorded before and after each intervention.
详细描述
Participants with cerebral palsy will undergo four experimental sessions on separate days in a randomized order. Each session will include either spinal manipulation or a sham intervention. Two sessions will involve spinal manipulation and two sessions will involve sham procedures.
Before and after each intervention, heart rate variability (HRV) will be measured under standardized conditions. The primary HRV parameter analyzed will be RMSSD, a time-domain measure reflecting vagal modulation of heart rate.
The crossover design allows each participant to serve as their own control, reducing inter-individual variability. The study focuses on the immediate autonomic effects of spinal manipulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral palsy
- •Motor function levels I-III according to GMFCS
- •Cooperative behavior
排除标准
- •Hyperkinetic forms
- •Use of medications affecting autonomic regulation
研究组 & 干预措施
Spinal manipulation
High-velocity, low-amplitude Spinal manipulation applied according to predefined clinical criteria in cervical, thoracic and lumbar regions of the spine .
干预措施: Spinal manipulation (Procedure)
Sham Procedure
Simulated procedure mimicking patient positioning and therapist contact without delivering a therapeutic thrust.
干预措施: Sham Procedure (Other)
结局指标
主要结局
Root Mean Square of Successive Differences (RMSSD)
时间窗: Time Frame: Immediately before and immediately after each intervention session
RMSSD will be calculated from short-term heart rate variability recordings obtained under standardized resting conditions. It reflects parasympathetic (vagal) modulation of heart rate. The primary outcome is the change in RMSSD from pre- to post-intervention within each session, comparing spinal manipulation and sham conditions.
次要结局
- Standard Deviation of Normal-to-Normal Intervals (SDNN)(Immediately before and immediately after each intervention session)
- Heart Rate (HR)(Immediately before and immediately after each intervention session)
- Low Frequency/High Frequency Ratio (LF/HF Ratio)(Immediately before and immediately after each intervention session)
研究者
Oleh Kachmar
MD, PhD
International Clinic of Rehabilitation, Ukraine