HealthyAxialNCT04434235
Effects of Additional Axial Load on Cervical Motor Control
An observational study of Healthy, run by Balgrist University Hospital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- axial load
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2019to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Young healthy adults
Who may be able to join
- Healthy participant's Signed informed consent after being informed
Who cannot join
- Acute pain Chronic neck pain Undergone Neck surgery Neck Disability Index Score > 15
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- axial load
- Keywords
- cervical spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axial loadOther
With a helmet with Velcro fastener we will add additional weight to produce axial load on the cervical spine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: axial load |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20 minutes group cervical stiffness
Secondary outcomes (3)
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.
Measured: 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)
Measured: 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.
Measured: 4 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Oct 2019
- Primary completion1 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaap Swanenburg, PhD, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434235
- Sponsor's protocol ID
- 2019-00830
- Other IDs
- 2019
- Acronym
- Axial
- Status last verified
- Jan 2021
- First submitted
- 28 Apr 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Additional Axial Load on Cervical Motor Control
- ClinicalTrials.gov ID
- NCT04434235
- Acronym / sponsor ID
- Axial / 2019-00830
- Conditions
- Healthy
- Keywords
- cervical spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic cervical stability | – | Other: axial loadThe 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. |
| Cervical Stiffness | – | Other: axial loadThe 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young healthy adults
Key inclusion criteria (1 listed)
- Healthy participant's Signed informed consent after being informed
Key exclusion criteria (1 listed)
- Acute pain Chronic neck pain Undergone Neck surgery Neck Disability Index Score > 15
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| axial loadWith a helmet with Velcro fastener we will add additional weight to produce axial load on the cervical spine | Other | Cervical Stiffness, Dynamic cervical stability |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Pain during measuring
Time frame: 2 minutes
Self-administered neck mobility
Time frame: 4 minutes
Neck Disability Index
Time frame: 4 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaap Swanenburg, PhD principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of neck joint-position error between differnent weight conditions (time frame: 20 minutes group cervical stiffness). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.