The Effect of Computerized Vestibular Function Assessment and Training System Combined With Cognitive/Motor Dual-task

NCT05990023 | Enrolling By Invitation

• 1 other identifier: N202212070
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effect of computerized vestibular function assessment and interactive training system, combined with cognitive/motor dual-task for the elderly with dizziness. The investigators will compare the movement abilities among older adults with different cognitive level, and further establish an assessment module that can evaluate participants' dual-task performance in both vestibular and cognitive tasks. Finally, leveraging the advantages of sensor detection technology and computerized feedback, an appropriate dual-task rehabilitation approach for vestibular function and cognition will be developed.

Conditions

Vestibular Function Disorder; Cognitive Decline; Dizziness; Vestibular Abnormality

Keywords

Vestibular function; Elderly cognition; Vestibular functional assessment; Vestibular vertigo

Outcome Measures

Primary Outcomes (19)

• Rotation of head, chest, and pelvis.

  Parameters from inertial sensors placed on the head, chest, and pelvis will be extracted. The parameters include rotational angles (degrees) of the head, chest, and waist.

  3 year.

• Inclination of head, chest, and pelvis.

  Parameters from inertial sensors placed on the head, chest, and pelvis will be extracted. The parameters include angular velocities (degrees per second) of the head, chest, and waist.

  3 year.

• Acceleration of head, chest, and pelvis.

  Parameters from inertial sensors placed on the head, chest, and pelvis will be extracted. The parameters include accelerations (meters per second squared) of the head, chest, and waist.

  3 year.

• Static Visual acuity.

  Parameters recorded by a screen with optotype chart and eyeglass system.

  3 year.

• Dynamic Visual acuity.

  Parameters recorded by a screen with optotype chart and eyeglass system during movements.

  3 year.

• Static vestibulo-ocular reflex (VOR gain)

  The VOR gain calculated by dividing eye movement velocity by head rotation velocity. The eye movement velocity(degree per second) and head rotation velocity(degree per second) are recorded by a screen, eyeglass system, and inertial sensor on subject's head.

  3 year.

• Dynamic vestibulo-ocular reflex. (VOR gain)

  The VOR gain calculated by dividing eye movement velocity by head rotation velocity. The eye movement velocity(degree per second) and head rotation velocity(degree per second) are recorded by a screen, eyeglass system, and inertial sensor on subject's head during movements.

  3 year.

• Step length (centimeter) during walking

  Step length (centimeter) recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.

  3 year.

• Step frequency

  Steps and times recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.

  3 year.

• Walking trajectory (centimeter)

  The shift(centimeter) of light and motion markers on subjects recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.

  3 year.

• Step width (centimeter) during walking

  The medial-lateral distance(centimeter) of light and motion markers on subject's feet recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation among the testing session.

  3 year.

• Step variability of step length (standard deviation) during walking

  The standard deviation of step length(centimeter) among the testing session. The step length(centimeter) is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation.

  3 year.

• Step variability of step width (standard deviation) during walking

  The standard deviation of step width(centimeter) among the testing session. The step width(centimeter) is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation.

  3 year.

• Speed (meter per second) during walking

  Speed (meter per second) calculated by dividing walking distances by total walking times. The walking distances and times are recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.

  3 year.

• Lower limb Joint force (Newton)

  Joint force is calculated by joint position(millimeter) and ground reaction force(Newton). The joint position(millimeter) is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera), and ground reaction force(Newton) is recorded by forceplates.

  3 year.

• Lower limb Joint moment (Newton-metre)

  Joint moment (Newton-metre) is calculated by multiplying ground reaction force(Newton) by limb length(meter). The limb length(meter) is recorded by meters or optical motion sensors(camera).

  3 year.

• Lower limb Joint power (Watt)

  Joint Power(watt) is calculated as the "scalar product" of joint moment and joint angular velocity(degree per second). The joint angular velocity (degree per second) is recorded by wearable sensors (inertial movement units) or optical motion sensors (camera).

  3 year.

• Joint movement (degree)

  Joint movement (degree) of subjects is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation.

  3 year.

• Body center of mass sway (millimeter) during testing session

  The shift (millimeter)) of light and motion markers on subject's pelvis recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) and forceplae during flat ground walking and up/down stairs situation.

  3 year.

Secondary Outcomes (9)

• Activities-Specific Balance Confidence Scale (ABC scale).

  3 year.

• Dizziness Handicap Inventory (DHI).

  3 year.

• Hospital Anxiety and Depression Scale (HADS).

  3 year.

• Dynamic Gait Index (DGI).

  3 year.

• Tinetti Fall Risk Assessment Tool (Tinetti Scale).

  3 year.

Study Arms (2)

Traditional vestibule rehabilitation training

ACTIVE COMPARATOR

The intervention for the control group primarily follows conventional rehabilitation methods but incorporates the computerized training system developed in this project.

Other: Traditional vestibule rehabilitation training

Dual-task vestibule rehabilitation training

EXPERIMENTAL

The intervention for the experimental group is based on the intervention for the control group, with additional components based on the findings from the second year of the study. These dual-task exercises are integrated into the training using the computerized training system and provided to the experimental group.

Other: Dual-task vestibule rehabilitation training

Interventions

Traditional vestibule rehabilitation training OTHER

* Standing, using a gaze tracking system on a force plate to track a continuously moving target, with alerts when body sway exceeds a certain threshold. * Standing, wearing an inertial sensor on the head and performing left-right or up-down head movements while maintaining gaze on a target, with a screen providing feedback on head movement speed. * Standing, controlling body weight distribution on the force plate to reach a target position, with a screen displaying the current center of gravity position. * Walking, synchronizing head movements with a rhythm or performing up-down head nods, with auditory cues indicating the desired head movement frequency. * During continuous head rotations, stepping in a regular sequence of forward, backward, left, and right movements.

Traditional vestibule rehabilitation training

Dual-task vestibule rehabilitation training OTHER

* Adding a dual task of digit countdown and recitation to clinical balance training exercises. * Incorporating a numerical calculation task into interactive screens during clinical balance training, with the participant's responses input by the researchers. * Introducing upper limb exercises, such as button pressing or arm swinging, during clinical balance training. * During continuous head rotations, following visual prompts on the display to perform forward, backward, left, and right displacements.

Dual-task vestibule rehabilitation training

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Year 1 (Study A):
• Could walk more than 30 meters with or without walking aids independently.
• Able to comprehend and communicate in Mandarin or Taiwanese.
• Sufficient corrected vision that allows independent outdoor mobility.
• Year 2 (Study B):
• Could walk more than 30 meters with or without walking aids independently.
• Able to comprehend and communicate in Mandarin or Taiwanese.
• Sufficient corrected vision that allows independent outdoor mobility.
• Healthy participants and those who have experienced dizziness or falls within the past two years.
• Year 3 (Study C):
• Could walk more than 30 meters with or without walking aids independently.
• Able to comprehend and communicate in Mandarin or Taiwanese.
• Sufficient corrected vision that allows independent outdoor mobility.
• Willing to engage in moderate-intensity exercise for 45 minutes per session.
• Participants who have experienced dizziness or falls within the past two years.

You may not qualify if:

• Year 1 (Study A):
• Severe central or peripheral nervous system disorders.
• Participants who are blind or deaf.
• Individuals who cannot communicate or understand instructions.
• Current fractures or significant joint injuries.
• Year 2 (Study B):
• Severe central or peripheral nervous system disorders.
• Participants who are blind or deaf.
• Individuals who cannot communicate or understand instructions.
• Current fractures or significant joint injuries.
• Year 3 (Study C):
• Severe central or peripheral nervous system disorders.
• Participants who are blind or deaf.
• Individuals who cannot communicate or understand instructions.
• Current fractures or significant joint injuries.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

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MeSH Terms

Conditions

Vestibular Diseases; Cognitive Dysfunction; Dizziness; Vertigo

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Study Officials

• Chen Po-Yin

  Taipei Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: August 14, 2023
• Study Start: November 1, 2023
• Primary Completion: February 14, 2026
• Study Completion (Estimated): May 14, 2026
• Last Updated: November 15, 2023

Record last verified: 2023-05

Locations

TW (1)