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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04434235
Other study ID # 2019-00830
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date August 1, 2020

Study information

Verified date January 2021
Source Balgrist University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Switzerland Balgrist University Hospital Zürich ZH

Sponsors (1)

Lead Sponsor Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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