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Completed

NCT Number: NCT04434235

Effects of Additional Axial Load on Cervical Motor Control

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.

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

Male

Study type

Observational

Primary location

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

axial load

Other

With a helmet with Velcro fastener we will add additional weight to produce axial load on the cervical spine

Primary outcomes

  1. Change of neck joint-position error between differnent weight conditions

    Time frame: 20 minutes group cervical stiffness

    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.

  2. Change of neck joint-position error between two sitting positions

    Time frame: 20 minutes group Dynamic cervical stability

    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.

  3. Change of neck range of motion between different weight conditions

    Time frame: 20 minutes group cervical stiffness

    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.

  4. Change of spinal stiffness between different sitting positions and loading conditions

    Time frame: 20 minutes group cervical stiffness

    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.

Secondary outcomes

  1. Pain during measuring

    Time frame: 2 minutes

    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. Self-administered neck mobility

    Time frame: 4 minutes

    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)

  3. Neck Disability Index

    Time frame: 4 minutes

    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.

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Acronym: Axial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2020
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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