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

NCT ID: NCT06323746

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2026-12-31

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.

Conditions

Cervical Lordosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Denneroll Group

The participants will be instructed to lie flat on their back on the ground with their legs extended and arms by their sides and gently folded across their stomach. The subject will place the Denneroll on the ground and the examiner positions the apex of the Denneroll.

The apex of the Denneroll orthotic will be placed in one of three regions based on lateral cervical radiographic displacements.

Group Type: EXPERIMENTAL

Denneroll cervical traction orthodontic

Intervention Type: DEVICE

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.

Wait List

This group will receive the same posture correction program after all data will be collected.

Group Type: OTHER

Denneroll cervical traction orthodontic

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sharjah

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Moustafa

Professor and Chairman of Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Sharjah

Sharjah city, , United Arab Emirates

Countries

United Arab Emirates

Central Contacts

Shima Zadeh

Role: CONTACT

Szadeh@sharjah.ac.ae

+971503077039

Ibrahim Mostafa Abuamr

Role: CONTACT

iabuamr@sharjah.ac.ae

Facility Contacts

Ibrahim Mostafa Abuamr, professor

Role: primary

iabuamr@sharjah.ac.ae

Other Identifiers

HR-EEG-CSAR

Identifier Type: -

Identifier Source: org_study_id