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

Primary Purpose

Vestibular Function Disorder, Cognitive Decline, Dizziness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Traditional vestibule rehabilitation training
Dual-task vestibule rehabilitation training
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Function Disorder focused on measuring Vestibular function, Elderly cognition, Vestibular functional assessment, Vestibular vertigo

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional vestibule rehabilitation training

Dual-task vestibule rehabilitation training

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Static Visual acuity.
Parameters recorded by a screen with optotype chart and eyeglass system.
Dynamic Visual acuity.
Parameters recorded by a screen with optotype chart and eyeglass system during movements.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.

Secondary Outcome Measures

Activities-Specific Balance Confidence Scale (ABC scale).
Clinical assessment scales to identify individuals with a fall risk. The minimum and maximum values are 0% and 100%, and whether higher scores mean a better outcome.
Dizziness Handicap Inventory (DHI).
Clinical assessment scales that quantifies the impact of dizziness on daily life. The minimum and maximum values are 0 and 100, and whether higher scores mean a worse outcome.
Hospital Anxiety and Depression Scale (HADS).
Clinical assessment scales to measure anxiety and depression in a general medical population of patients. The minimum and maximum values are 0 and 42, and whether higher scores mean a worse outcome.
Dynamic Gait Index (DGI).
Clinical assessment scales to test the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. The minimum and maximum values are 0 and 24, and whether higher scores mean a better outcome.
Tinetti Fall Risk Assessment Tool (Tinetti Scale).
Clinical assessment scales to test the walking and balance ability to valuate the falling risk. The minimum and maximum values are 0 and 28, and whether higher scores mean a better outcome.
Montreal Cognitive Assessment Taiwanese version (MoCA).
Cognitive-related assessments. The minimum and maximum values are 0 and 30, and whether higher scores mean a better outcome. The minimum and maximum values are 0 and 24, and whether higher scores mean a better outcome.
Trail Making Test.
Clinical assessment scales which provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Longer time consumed means worse performance. An average score for TMT-A is 29 seconds and a deficient score is greater than 78 seconds. For TMT-B, an average score is 75 seconds and a deficient score is greater than 273 seconds.
Digit Span Test.
Clinical assessment scales to test subject's ability to remember a sequence of numbers that appear on the screen, one at a time. The minimum and maximum values are 0 and 21, and whether higher scores mean a better outcome.
Stroop Test.
Clinical assessment scales for color recognize.The minimum and maximum values are 1% and 100%, and whether the higher percentage rates mean better performance

Full Information

First Posted
May 22, 2023
Last Updated
August 4, 2023
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05990023
Brief Title
The Effect of Computerized Vestibular Function Assessment and Training System Combined With Cognitive/Motor Dual-task
Official Title
Investigating the Effect of Computerized Vestibular Function Assessment and Interactive Training System, Combined With Cognitive/Motor Dual-task for the Elderly With Dizziness
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 10, 2023 (Anticipated)
Primary Completion Date
February 14, 2026 (Anticipated)
Study Completion Date
May 14, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Dizziness is one of the most common complaints among older adults and often a concern within healthcare systems. It leads to distressing sensations, reduced mobility, and decreased quality of life. Dizziness is also closely associated with falls, which are a major cause of comorbidities and mortality in older adults. During clinical rehabilitation training, it has been observed that some elderly patients with vestibular dizziness often experience difficulties with speech clarity, lack of attention, poor direction control, or easy forgetfulness of rehabilitation training content. Similar observations have been made by scholars who interacted with dizzy patients, noting difficulties in maintaining attention, deficits in attention and spatial memory, speech expression impairments, and impacts on spatial memory, fluency of speech, thinking abilities, calculation impairments, and other forms of numerical cognition. Clinical studies have already noted the association between vestibular dysfunction and cognitive impairment. However, there is limited research that can clarify the intricacies and complexities of this issue. Currently, there is scarce knowledge regarding the relationship between the vestibular system and specific cognitive aspects, as well as its correlation with balance deficits. 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. Drawing from previous clinical rehabilitation experiences, a method for assessing vestibular function and balance performance will be designed to compare the movement differences among older adults with different cognitive performances. Subsequently, through scientific and objective motion capture analysis, a comprehensive assessment module will be established to evaluate the dual-task performance of participants in both vestibular and cognitive tasks. The performance differences attributed to cognition will be analyzed, and the correlation with vestibular function performance will be integrated to serve as a prescription reference for computer-assisted rehabilitation interventions. 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. Methods: First year, the study will recruit 60 elderly people and integrate the use of inertial sensors and force plates with vestibular and balance tests to establish a vertigo assessment system for the elderly. In the second year, the subjects were divided into two groups: a control group of 25 healthy elderly people, and an experimental group of 25 elderly people who had experienced dizziness and falls in the past two years. Data were collected using a motion analysis system combined with a computerized assisted assessment. The main analysis is whether the experience of dizziness or fall affects the balance, vestibular and cognitive related activities. In the third year, 40 vestibular hypofunction patients will be randomized into either traditional or dual-task group. Both groups will receive 2~3 times per week for 4 weeks of computerized vestibular interventions with and without dual-task training protocols. Expected achievements: Combining safe stochastic dual-task training and computer-assisted rehabilitation interventions in this 3-year project, the mechanisms of cognition related to vestibular training will be elucidated. The optimal strategy for vestibular rehabilitation can thus be established.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Function Disorder, Cognitive Decline, Dizziness, Vestibular Abnormality
Keywords
Vestibular function, Elderly cognition, Vestibular functional assessment, Vestibular vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional vestibule rehabilitation training
Arm Type
Active Comparator
Arm Description
The intervention for the control group primarily follows conventional rehabilitation methods but incorporates the computerized training system developed in this project.
Arm Title
Dual-task vestibule rehabilitation training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional vestibule rehabilitation training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dual-task vestibule rehabilitation training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rotation of head, chest, and pelvis.
Description
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.
Time Frame
3 year.
Title
Inclination of head, chest, and pelvis.
Description
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.
Time Frame
3 year.
Title
Acceleration of head, chest, and pelvis.
Description
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.
Time Frame
3 year.
Title
Static Visual acuity.
Description
Parameters recorded by a screen with optotype chart and eyeglass system.
Time Frame
3 year.
Title
Dynamic Visual acuity.
Description
Parameters recorded by a screen with optotype chart and eyeglass system during movements.
Time Frame
3 year.
Title
Static vestibulo-ocular reflex (VOR gain)
Description
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.
Time Frame
3 year.
Title
Dynamic vestibulo-ocular reflex. (VOR gain)
Description
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.
Time Frame
3 year.
Title
Step length (centimeter) during walking
Description
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.
Time Frame
3 year.
Title
Step frequency
Description
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.
Time Frame
3 year.
Title
Walking trajectory (centimeter)
Description
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.
Time Frame
3 year.
Title
Step width (centimeter) during walking
Description
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.
Time Frame
3 year.
Title
Step variability of step length (standard deviation) during walking
Description
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.
Time Frame
3 year.
Title
Step variability of step width (standard deviation) during walking
Description
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.
Time Frame
3 year.
Title
Speed (meter per second) during walking
Description
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.
Time Frame
3 year.
Title
Lower limb Joint force (Newton)
Description
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.
Time Frame
3 year.
Title
Lower limb Joint moment (Newton-metre)
Description
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).
Time Frame
3 year.
Title
Lower limb Joint power (Watt)
Description
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).
Time Frame
3 year.
Title
Joint movement (degree)
Description
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.
Time Frame
3 year.
Title
Body center of mass sway (millimeter) during testing session
Description
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.
Time Frame
3 year.
Secondary Outcome Measure Information:
Title
Activities-Specific Balance Confidence Scale (ABC scale).
Description
Clinical assessment scales to identify individuals with a fall risk. The minimum and maximum values are 0% and 100%, and whether higher scores mean a better outcome.
Time Frame
3 year.
Title
Dizziness Handicap Inventory (DHI).
Description
Clinical assessment scales that quantifies the impact of dizziness on daily life. The minimum and maximum values are 0 and 100, and whether higher scores mean a worse outcome.
Time Frame
3 year.
Title
Hospital Anxiety and Depression Scale (HADS).
Description
Clinical assessment scales to measure anxiety and depression in a general medical population of patients. The minimum and maximum values are 0 and 42, and whether higher scores mean a worse outcome.
Time Frame
3 year.
Title
Dynamic Gait Index (DGI).
Description
Clinical assessment scales to test the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. The minimum and maximum values are 0 and 24, and whether higher scores mean a better outcome.
Time Frame
3 year.
Title
Tinetti Fall Risk Assessment Tool (Tinetti Scale).
Description
Clinical assessment scales to test the walking and balance ability to valuate the falling risk. The minimum and maximum values are 0 and 28, and whether higher scores mean a better outcome.
Time Frame
3 year.
Title
Montreal Cognitive Assessment Taiwanese version (MoCA).
Description
Cognitive-related assessments. The minimum and maximum values are 0 and 30, and whether higher scores mean a better outcome. The minimum and maximum values are 0 and 24, and whether higher scores mean a better outcome.
Time Frame
3 year.
Title
Trail Making Test.
Description
Clinical assessment scales which provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Longer time consumed means worse performance. An average score for TMT-A is 29 seconds and a deficient score is greater than 78 seconds. For TMT-B, an average score is 75 seconds and a deficient score is greater than 273 seconds.
Time Frame
3 year.
Title
Digit Span Test.
Description
Clinical assessment scales to test subject's ability to remember a sequence of numbers that appear on the screen, one at a time. The minimum and maximum values are 0 and 21, and whether higher scores mean a better outcome.
Time Frame
3 year.
Title
Stroop Test.
Description
Clinical assessment scales for color recognize.The minimum and maximum values are 1% and 100%, and whether the higher percentage rates mean better performance
Time Frame
3 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Po-Yin, PhD
Phone
(02)27361661
Ext
6311
Email
poyin1128@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Po-Yin
Organizational Affiliation
Taipei Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Po-Yin Chen, PhD
Phone
(02)27361661
Ext
6311
Email
poyin1128@tmu.edu.tw

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

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