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

U

University of Sharjah

Status

Not yet enrolling

Conditions

Cervical Lordosis

Treatments

Device: Denneroll cervical traction orthodontic

Study type

Interventional

Funder types

Other

Identifiers

NCT06323746
HR-EEG-CSAR

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Denneroll Group
Experimental group
Description:
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.
Treatment:
Device: Denneroll cervical traction orthodontic
Wait List
Other group
Description:
This group will receive the same posture correction program after all data will be collected.
Treatment:
Device: Denneroll cervical traction orthodontic

Trial contacts and locations

1

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Central trial contact

Ibrahim Mostafa Abuamr; Shima Zadeh

Data sourced from clinicaltrials.gov

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