Clinical trial NCT04626544: Dynamic Neck Function During Gait in Patients With Dizziness
Official title: Dynamic Neck Function During Gait in Patients With Dizziness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dizziness
Neck Pain
Gait
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Western Norway University of Applied Sciences
First posted: 2020-11-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

Locally referred Patients to an ear-nose-and throat (ENT) clinic at an University Hospital for dizziness symptoms.

Exclusion Criteria:

Any severe neurologic or orthopedic disease affecting gait.

Primary outcomes:
measure: Accelerometer data (anteroposteriorly, mediolaterally and vertically) and gyrometer data (yaw, pitch and roll).
timeFrame: Baseline
measure: Video analysis: Three-dimensional motion capture
timeFrame: Baseline
Secondary outcomes:
measure: Dizziness Handicap Inventory (DHI)
timeFrame: Baseline
measure: Neck Disability Index (NDI)
timeFrame: Baseline
measure: Vertigo symptom Scale - Short form
timeFrame: Baseline
measure: Numeric pain rating scale (NPRS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Høgskulen på Vestlandet
state: Vestland
Study officials:
affiliation: Haukeland University Hospital
name: Frederik Kragerud Goplen, PhD
role: PRINCIPAL_INVESTIGATOR
References: