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Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration

Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration: A Randomized Controlled Trial Investigation

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06323746
Enrollment
80
Registered
2024-03-21
Start date
2024-05-31
Completion date
2026-12-31
Last updated
2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Lordosis

Keywords

Cervical Lordosis, Athlete, Electroencephalography, Heart Rate

Brief summary

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

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.

Sponsors

University of Sharjah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cervical Sagittal Alignment RadiographsBaseline (pre-treatment), week 10 (upon completion) and after 6 monthsThe change of cervical lordosis from the absolute rotatory angle C2-7.

Secondary

MeasureTime frameDescription
Heart rate Variability (HRV) physiological parameterBaseline (pre-treatment), week 10 (upon completion) and after 6 monthsThe change in Heart rate through Electrocardiographic recordings (ECG) will be monitored using a Nexus-10 physiologic monitoring system. Recordings will be made simultaneously through three separate channels. The ground electrode will be placed below the left clavicle, the cathode (-) below the right clavicle and the anode (+) will be placed on the third rib, in line with the ground. HRV time parameter will be calculated from respiratory rate (RR) intervals (Standard deviation of the normal to normal intervals (SDNN), Root-mean-square of the successive normal sinus RR interval difference (RMSSD) and the percentage of absolute differences between successive normal RR intervals that exceed 50 ms (pNN50)). HRV frequency domain variable will include total power, high frequency (HF) and low frequency (LF) power (measured in ms2) and LF:HF ratio were derived from spectral analysis of successive R-R intervals.
Corticomuscular CoherenceBaseline (pre-treatment), week 10 (upon completion) and after 6 monthsThe change in the ratio between Muscle activity through Electromyography (EMG) and brain waves through Electroencephalograph (EEG)

Countries

United Arab Emirates

Contacts

Primary ContactShima Zadeh
Szadeh@sharjah.ac.ae+971503077039
Backup ContactIbrahim Mostafa Abuamr
iabuamr@sharjah.ac.ae

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026