Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Denneroll cervical traction orthodontic.
- Who it may be relevant to
- Registry conditions: Cervical Lordosis. Basic parameters: 18 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Arab Emirates
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration: A Randomized Controlled Trial Investigation
Overview
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.
Detailed description
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.
Interventions
- Device Denneroll cervical traction orthodontic
The duration of each session will start at approximately three minutes and increase by one minute per session until reaching the goal of 20 minutes per session. The intervention will be repeated three times per week for 10 weeks in the supervised setting.
Primary outcome measures
- Cervical Sagittal Alignment Radiographs [Time frame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months]
- Cervical Sagittal Alignment Radiographs [Time frame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months]
Secondary outcome measures (2)
- Heart rate Variability (HRV) physiological parameter [Time frame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months]
- Corticomuscular Coherence [Time frame: Baseline (pre-treatment), week 10 (upon completion) and after 6 months]
Eligibility criteria
Inclusion criteria
- Anterior head translation (AHT) >15 mm
- Absolute rotatory angle C2 to C7 is <25°
- Athletic student
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United Arab Emirates · 1 center
- University of Sharjah — Sharjah city
Identifiers
NCT: NCT06323746 · HR-EEG-CSAR