Dynamic Neck Function During Gait in Patients With Dizziness

NCT04626544 | Unknown

• 1 other identifier: 169388
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Dizziness; Neck Pain; Gait

Outcome Measures

Primary Outcomes (2)

• 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/).

  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.

  Baseline

Secondary Outcomes (4)

• Dizziness Handicap Inventory (DHI)

  Baseline

• Neck Disability Index (NDI)

  Baseline

• Vertigo symptom Scale - Short form

  Baseline

• Numeric pain rating scale (NPRS)

  Baseline

Study Arms (2)

Dizziness

Patients with dizziness referred to a secondary referral center

Device: Body-worn inertial sensors

Healthy controls

Healthy controls without dizziness or neck pain symptoms for the last 3 months

Device: Body-worn inertial sensors

Interventions

Body-worn inertial sensors DEVICE

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/).

Dizziness; Healthy controls

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Any severe neurologic or orthopedic disease affecting gait.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Western Norway University of Applied Sciences: collaborator

Study Sites (1)

Høgskulen på Vestlandet

Bergen, Vestland, Norway

RECRUITING

MeSH Terms

Conditions

Dizziness; Neck Pain

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• Frederik Kragerud Goplen, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mari Kalland Knapstad, PhD

CONTACT

+47 90524929; mariknap@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 12, 2020
• Study Start: January 10, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)