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

NCT06323746 | Not Yet Recruiting

• 1 other identifier: HR-EEG-CSAR
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Lordosis

Keywords

Cervical Lordosis; Athlete; Electroencephalography; Heart Rate

Outcome Measures

Primary Outcomes (2)

• Cervical Sagittal Alignment Radiographs

  The change of cervical lordosis from the absolute rotatory angle C2-7.

  Baseline (pre-treatment), week 10 (upon completion) and after 6 months

• Cervical Sagittal Alignment Radiographs

  The amount of the change in the anterior head translation from the horizontal offset of the posterior superior body corner of C2 relative to the vertical line.

  Baseline (pre-treatment), week 10 (upon completion) and after 6 months

Secondary Outcomes (2)

• Heart rate Variability (HRV) physiological parameter

  Baseline (pre-treatment), week 10 (upon completion) and after 6 months

• Corticomuscular Coherence

  Baseline (pre-treatment), week 10 (upon completion) and after 6 months

Study Arms (2)

Denneroll Group

EXPERIMENTAL

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.

Device: Denneroll cervical traction orthodontic

Wait List

OTHER

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

Device: Denneroll cervical traction orthodontic

Interventions

Denneroll cervical traction orthodontic 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.

Denneroll Group; Wait List

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Anterior head translation (AHT) \>15 mm
• Absolute rotatory angle C2 to C7 is \<25°
• Athletic student

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

University of Sharjah

Sharjah city, 0000, United Arab Emirates

Location

Central Study Contacts

Shima Zadeh

CONTACT

+971503077039; Szadeh@sharjah.ac.ae

Ibrahim Mostafa Abuamr

CONTACT

iabuamr@sharjah.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman of Physiotherapy

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 21, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)