DizzinessNCT04626544
Dynamic Neck Function During Gait in Patients With Dizziness
An observational study of Dizziness and Neck Pain, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
This study aims to explore the possible association between dizziness and head-on trunk-movements and thus, neck movement and if this differs to healthy controls. Additional, the study will examine the reliability and validity of using wearable accelerometers to examine how the head moves relative to the trunk and to… Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- What is being tested?
- Body-worn inertial sensors
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteNorway
- Study dates
- 10 Jan 2022to Jun 2024
- 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 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients with dizziness between the ages of 18 - 70 will be recruited from the ear-nose-and throat (ENT) clinic at Haukeland University Hospital (HUS). The clinic admits approximately 1200 patients yearly referred for dizziness and balance issues. All participants recruited form the ENT-clinic will be examined and diagnosed by an otorhinolaryngologist. A group of healthy controls between the ages of 18 - 70 will be recruited to generate normative data. A total of 10 participants of each gender will be recruited in the age groups 18 - 30, 31 - 50, 51 - 70. The participants have to be free of any vestibular symptoms and neck pain, going back the last three months, and they have to be free of any severe neurologic or orthopedic disease affecting gait.
Who may be able to join
- Locally referred Patients to an ear-nose-and throat (ENT) clinic at an University Hospital for dizziness symptoms.
Who cannot join
- Any severe neurologic or orthopedic disease affecting gait.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Høgskulen på Vestlandet
Bergen, Vestland
Mari Kalland Knapstad, PhD
About this study
This study aims to explore the possible association between dizziness and head-on trunk-movements and thus, neck movement and if this differs to healthy controls. Additional, the study will examine the reliability and validity of using wearable accelerometers to examine how the head moves relative to the trunk and to collect normative data on head on trunk movement.
Read the detailed description
Patients with dizziness will be recruited from a ear-nose and throat clinic. After giving written consent the patients will be tested with wearable sensors on their occiput and C6 vertebra during gait. Healthy controls will be recruited from students and employees at the Western Norway University of Applied Science and go through the same protocol as the patients.
The investigators will measure the relationship between the two sensors to explore how patients with dizziness move their-on-trunk during gait.
The projects main hypothesis is that patient with dizziness have reduced attenuation of gait-associated head oscillations with increased coupling of head-on-trunk motion, compared to healthy controls. The neck does not compensate for trunk movements, causing the head to follow the movement of the trunk.
- Being tested
- Body-worn inertial sensors
- Medical subject headings
- Dizziness, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body-worn inertial sensorsDevice
The device typically includes accelerometers that capture body accelerations in three directions (anteroposteriorly, mediolaterally and vertically) and gyrometers that capture rotations (yaw, pitch and roll). The method of measuring gait using body-worn inertial sensors has been found reliable [15] and valid [20]. This project will use Opal sensors and the Mobility Lab software from the manufacturer APDM (https://www.apdm.com/wearable-sensors/).
| Study group | Role | What they receive |
|---|---|---|
| Dizziness | Patients with dizziness referred to a secondary referral center Receives: Device: Body-worn inertial sensors | |
| Healthy controls | Healthy controls without dizziness or neck pain symptoms for the last 3 months Receives: Device: Body-worn inertial sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometer data (anteroposteriorly, mediolaterally and vertically) and gyrometer data (yaw, pitch and roll).
The outcome is the difference/regression between the sensor placed on the participant head and the sensor placed on the participants C6 vertebra. The method of measuring gait using body-worn inertial sensors has been found reliable and valid. This project will use Opal sensors and the Mobility Lab software from the manufacturer APDM (https://www.apdm.com/wearable-sensors/).
Measured: Baseline
Video analysis: Three-dimensional motion capture
Three-dimensional motion capture is considered the gold standard of movement analysis. Using this method, reflective markers are placed on specified body landmarks. The subject is then filmed from different angles using several cameras, allowing for analysis of the markers relative to one another. Both rotation and acceleration is captured this way. The project will use an eight-camera system from Qualisys, with analyses performed using Visual 3D software.
Measured: Baseline
Secondary outcomes (4)
Dizziness Handicap Inventory (DHI)
The severity of dizziness handicap will be evaluated using a Norwegian version of the Dizziness Handicap Inventory (DHI) [24]. This questionnaire aims to quantify the handicap experienced by dizziness. It contains 25 items with a maximum score of 100. A score > 29 indicates disability. The Norwegian version of the questionnaire has been validated and the sum score demonstrates satisfactory measurement properties.
Measured: Baseline
Neck Disability Index (NDI)
The degree of neck disability will be measured with the Neck Disability Index (NDI) [26]. The NDI consists of 10 items with each score on a 0 to 5 rating scale and a total range of 0 - 50. Scores between 0-and 4 indicate no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability and 35-50 complete disability [26]. The index has been validated in the evaluation of pain and disability in acute and chronic conditions. The Norwegian version has shown good test-retest reliability.
Measured: Baseline
Vertigo symptom Scale - Short form
To measure the degree of dizziness symptom severity, the Vertigo Symptom Scale - short form (VSSsf) will be used. The form comprise 15 items, and the patients answer how frequently they have experienced symptoms in the past month on a scale from 0-4, giving a range of score from 0 to 60. A higher score indicates increased symptom severity. A score ≥ 12 points on the total scale indicates severe dizziness. The total scale can be subdivided into two subscales measuring severity of autonomic symptoms, such as sweating, heart pounding and nausea, and severity of vertigo and balance symptoms. The questionnaire with its subscales has been validated into Norwegian.
Measured: Baseline
Numeric pain rating scale (NPRS)
Patients reporting neck pain will be asked to rate their neck pain during the two last weeks on an 11-point scale. The NPRS has previously shown adequate reliability and validity in patients with chronic pain conditions, including neck pain.The pain is rated from 0 to 10 where 0 represents no pain and 10 represents the worst imaginable pain.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start10 Jan 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DizzinessStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Western Norway University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Frederik Kragerud Goplen, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626544
- Sponsor's protocol ID
- 169388
- Status last verified
- Apr 2023
- First submitted
- 10 Nov 2020
- Last updated
- 9 May 2023
- 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Neck Function During Gait in Patients With Dizziness
- ClinicalTrials.gov ID
- NCT04626544
- Acronym / sponsor ID
- 169388
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Western Norway University of Applied Sciences
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 12 Nov 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.
This study aims to explore the possible association between dizziness and head-on trunk-movements and thus, neck movement and if this differs to healthy controls. Additional, the study will examine the reliability and validity of using wearable accelerometers to examine how the head moves relative to the trunk and to collect normative data on head on trunk movement.
Detailed description
Patients with dizziness will be recruited from a ear-nose and throat clinic. After giving written consent the patients will be tested with wearable sensors on their occiput and C6 vertebra during gait. Healthy controls will be recruited from students and employees at the Western Norway University of Applied Science and go through the same protocol as the patients.
The investigators will measure the relationship between the two sensors to explore how patients with dizziness move their-on-trunk during gait.
The projects main hypothesis is that patient with dizziness have reduced attenuation of gait-associated head oscillations with increased coupling of head-on-trunk motion, compared to healthy controls. The neck does not compensate for trunk movements, causing the head to follow the movement of the trunk.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dizziness | – | Device: Body-worn inertial sensorsPatients with dizziness referred to a secondary referral center |
| Healthy controls | – | Device: Body-worn inertial sensorsHealthy controls without dizziness or neck pain symptoms for the last 3 months |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with dizziness between the ages of 18 - 70 will be recruited from the ear-nose-and throat (ENT) clinic at Haukeland University Hospital (HUS). The clinic admits approximately 1200 patients yearly referred for dizziness and balance issues. All participants recruited form the ENT-clinic will be examined and diagnosed by an otorhinolaryngologist. A group of healthy controls between the ages of 18 - 70 will be recruited to generate normative data. A total of 10 participants of each gender will be recruited in the age groups 18 - 30, 31 - 50, 51 - 70. The participants have to be free of any vestibular symptoms and neck pain, going back the last three months, and they have to be free of any severe neurologic or orthopedic disease affecting gait.
Key inclusion criteria (1 listed)
- Locally referred Patients to an ear-nose-and throat (ENT) clinic at an University Hospital for dizziness symptoms.
Key exclusion criteria (1 listed)
- Any severe neurologic or orthopedic disease affecting gait.
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 |
|---|---|---|
| Body-worn inertial sensorsThe device typically includes accelerometers that capture body accelerations in three directions (anteroposteriorly, mediolaterally and vertically) and gyrometers that capture rotations (yaw, pitch and roll). The method of measuring gait using body-worn inertial sensors has been found reliable [15] and valid [20]. This project will use Opal sensors and the Mobility Lab software from the manufacturer APDM (https://www.apdm.com/wearable-sensors/). | Device | Dizziness, Healthy controls |
Primary outcome
Accelerometer data (anteroposteriorly, mediolaterally and vertically) and gyrometer data (yaw, pitch and roll).
Time frame: Baseline
The outcome is the difference/regression between the sensor placed on the participant head and the sensor placed on the participants C6 vertebra. The method of measuring gait using body-worn inertial sensors has been found reliable and valid. This project will use Opal sensors and the Mobility Lab software from the manufacturer APDM (https://www.apdm.com/wearable-sensors/).
Video analysis: Three-dimensional motion capture
Time frame: Baseline
Three-dimensional motion capture is considered the gold standard of movement analysis. Using this method, reflective markers are placed on specified body landmarks. The subject is then filmed from different angles using several cameras, allowing for analysis of the markers relative to one another. Both rotation and acceleration is captured this way. The project will use an eight-camera system from Qualisys, with analyses performed using Visual 3D software.
4 secondary outcomes
Dizziness Handicap Inventory (DHI)
Time frame: Baseline
Neck Disability Index (NDI)
Time frame: Baseline
Vertigo symptom Scale - Short form
Time frame: Baseline
Numeric pain rating scale (NPRS)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- 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.
Frederik Kragerud Goplen, PhD principal investigator
Haukeland 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 Dizziness and Neck Pain, run by Haukeland University Hospital at 1 site in Norway.
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: status not confirmed, as of the sponsor's last update on 9 May 2023. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mari Kalland Knapstad, PhD (+47 90524929, mariknap@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerometer data (anteroposteriorly, mediolaterally and vertically) and gyrometer data (yaw, pitch and roll). (time frame: Baseline). The study lists 2 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 9 May 2023.