Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration: A Randomized Controlled Trial Investigation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cervical Sagittal Alignment Radiographs
研究概览
简要总结
The goal of this Randomized clinical trial is to learn about how fixing neck curvature and head posture right away affects heart rate, brainwaves, and muscle coordination in college athletes. The main question it aims to answer:
- Whether forward head posture (FHP) may play a crucial role in affecting heart rate variability, brainwaves, and muscle coordination.
详细描述
Background: Restoring normal cervical spine alignment has emerged as one of the most important clinical outcomes in healthcare. However, the question of whether cervical biomechanical dysfunction manifesting as forward head posture (FHP) may play a crucial role in affecting heart rate variability, as an indicator of the autonomic nervous system, electroencephalography (EEG) pattern, as indictor for brain waves, and corticomuscular coherence, as an indicator of the functional connection between the cortex and muscles during continuous muscle contractions among collegiate athletes has not been answered yet.
Objective
To investigate the immediate and long-term effects of cervical lordosis restoration and forward head correction using the Denneroll™ on heart rate variability, EEG pattern, and corticomuscular coherence among collegiate athletes.
Methods: Eighty asymptomatic subjects with a definite hypolordotic cervical spine and FHP will be randomly assigned to an experimental group or a control group. The experimental group will receive the Denneroll™ cervical traction while the control group will be considered as a wait list to start the intervention after completion of the experimental group. Interventions will be applied 3 times per week for a period of 10 weeks. Changes in heart rate variability, EEG pattern and corticomuscular coherence will be assessed at three-time intervals: at baseline, after 10 weeks of intervention, and at 6-months follow up with no further interventions.
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 (Outcomes Assessor)
盲法说明
Permuted block randomization to ensure an equal number of allocations in each of the two groups (intervention and wait list group). Each random block will be stored in opaque sealed envelopes consecutively numbered with a third researcher. Once each participant officially joins the study the researcher will open the subsequent envelop.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Anterior head translation (AHT) >15 mm
- •Absolute rotatory angle C2 to C7 is <25°
- •Athletic student
排除标准
- •Inflammatory joint disease or other systemic pathologies
- •Prior history of overt injury and surgery relating to the musculoskeletal system, or disorder related to the spine and extremities
- •Musculoskeletal pain in the previous three months.
结局指标
主要结局
Cervical Sagittal Alignment Radiographs
时间窗: Baseline (pre-treatment), week 10 (upon completion) and after 6 months
The change of cervical lordosis from the absolute rotatory angle C2-7.
次要结局
- Corticomuscular Coherence(Baseline (pre-treatment), week 10 (upon completion) and after 6 months)
- Heart rate Variability (HRV) physiological parameter(Baseline (pre-treatment), week 10 (upon completion) and after 6 months)
研究者
Ibrahim Moustafa
Professor and Chairman of Physiotherapy
University of Sharjah