Effects of Additional Axial Load on Cervical Motor Control (Axial)

he objective of this study is to examine the influence of additional axial load abd body position on cervical motor control in young healthy adults.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: axial load

Detailed Description

Motor control of the cervical spine is impotent for responsible for maintaining balance during daily living activities and to withstand external loads. Stabilization-aspects of the cervical spine is very complex, passive (ligaments, joint capsule and the skin and active (muscles), and neurological subsystems are involved. Mostly proprioceptive testing and exercises like head and neck position sense testing and re-training have been an integral part of rehabilitation. Another method to evaluate spinal motor control is the assessment of spinal stiffness. The main objective of this study is to explore the effects of additional axial loading on motion control in healthy individuals. Does the motor control of the cervical spine in healthy subjects change with additional axial load or body position? A better understanding of spinal stiffness and neck position sense leads to novel insights into spinal cervical stabilization mechanisms.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zürich, ZH, Switzerland, 8008
      • Balgrist University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Young healthy adults

Description

Inclusion Criteria:

Healthy participant's Signed informed consent after being informed

Exclusion Criteria:

Acute pain Chronic neck pain Undergone Neck surgery Neck Disability Index Score > 15

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dynamic cervical stability; The participant is asked to move the head in 6 directions in a sitting position and 30° leaning backward sitting position; lateral flexion (left / right), flexion, extension, and rotation (left / right). Results are to be taken for each direction and random at each axial load-level (0 kg, 1kg, 2 kg, and 3 kg). In total 24 measurements. The duration of all measurement will be 60 minutes.	Other: axial load; With a helmet with Velcro fastener we will add additional weight to produce axial load on the cervical spine
Cervical Stiffness; The participant is asked to move the head in 4 directions; flexion, extension, and rotation (left / right). Joint-Position Error measurements will be executed in neutral sitting position. Additionally, stiffness will be measured in neutral sitting position and neutral sitting position with 45° cervical flexion. All measurements will be performed with 0 kg and 3 kg axal loading. In total 18 measurements.The duration of all measurement will be 60 minutes.	Other: axial load; With a helmet with Velcro fastener we will add additional weight to produce axial load on the cervical spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of neck joint-position error between differnent weight conditions	Joint-position error will be will be assessed with Sensomove. It consists of the 3D senscoordination sensor, an adjustable headband, and basic software for motion feedback of head movements. The change of Joint-Position Error with and without additional axial load will be assessed.	20 minutes group cervical stiffness
Change of neck joint-position error between two sitting positions	Joint-position error will be will be assessed with Sensomove It consists of the 3D senscoordination sensor, an adjustable headband, and basic software for motion feedback of head movements. The change of Joint-Position Error with axial load (3kg) between two sitting positions will be assessed.	20 minutes group Dynamic cervical stability
Change of neck range of motion between different weight conditions	Range of motion will be will be assessed with Sensomove It consists of the 3D senscoordination sensor, an adjustable headband, and basic software for motion feedback of head movements. The change of Rage of motion with and without additional axial load will be assessed.	20 minutes group cervical stiffness
Change of spinal stiffness between different sitting positions and loading conditions	The device measures tissue compliance according to the concept of impulse-response. A force of exact 20 Newton will be applied from the device to the process spinous. The expected impulse-response (result) will be between 20 Newton and 40 Newton. The change of spinal stiffness due sitting position and loading will be assessed.	20 minutes group cervical stiffness

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during measuring	The visual analogue scale will be used to quantify pain, if any of the measurements is painful. The participant is asked to rate his pain intensity on a straight line (100mm) with two endpoints.	2 minutes
Self-administered neck mobility	Self-administered neck mobility questionnaire is a self-administered questionnaire that uses visual analog scales to measure pain-free active rage of motion for all neck movements. The patient is asked to place a mark on a 100 mm line (0 mm = "no movement possible" and 100 mm = "as far as possible"). The total score is the sum of the individual scores (min. score (600) = no restrictions and max. score (0) = total restriction)	4 minutes
Neck Disability Index	The Neck Disability Index is a self-report questionnaire with 10-items: pain intensity, personal care, lifting, work, headaches, concentration, sleeping, driving, reading, and recreation. The response to each item is rated on a 6-point scale from 0 (no disability) to 5 (complete disability). The numeric responses for each item are summed for a total score ranging between 0 and 50.	4 minutes

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Investigators: Principal Investigator: Jaap Swanenburg, PhD, Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: cervical spine
• Other Study ID Numbers: 2019-00830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No