NCT04434235

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

April 28, 2020

Last Update Submit

January 14, 2021

Conditions

Keywords

cervical spine

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Pain during measuring

    2 minutes

  • Self-administered neck mobility

    4 minutes

  • Neck Disability Index

    4 minutes

Study Arms (2)

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

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

Interventions

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

Cervical StiffnessDynamic cervical stability

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young healthy adults

You may qualify if:

  • Healthy participant's Signed informed consent after being informed

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Interventions

Weight-Bearing

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Officials

  • Jaap Swanenburg, PhD

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

June 16, 2020

Study Start

October 1, 2019

Primary Completion

July 1, 2020

Study Completion

August 1, 2020

Last Updated

January 19, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations