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

T

Taipei Medical University

Status

Invitation-only

Conditions

Vestibular Function Disorder
Vestibular Abnormality
Dizziness
Cognitive Decline

Treatments

Other: Dual-task vestibule rehabilitation training
Other: Traditional vestibule rehabilitation training

Study type

Interventional

Funder types

Other

Identifiers

NCT05990023
N202212070

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

55 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Year 1 (Study A):

    1. Could walk more than 30 meters with or without walking aids independently.
    2. Able to comprehend and communicate in Mandarin or Taiwanese.
    3. Sufficient corrected vision that allows independent outdoor mobility.
  • Year 2 (Study B):

    1. Could walk more than 30 meters with or without walking aids independently.
    2. Able to comprehend and communicate in Mandarin or Taiwanese.
    3. Sufficient corrected vision that allows independent outdoor mobility.
    4. Healthy participants and those who have experienced dizziness or falls within the past two years.
  • Year 3 (Study C):

    1. Could walk more than 30 meters with or without walking aids independently.
    2. Able to comprehend and communicate in Mandarin or Taiwanese.
    3. Sufficient corrected vision that allows independent outdoor mobility.
    4. Willing to engage in moderate-intensity exercise for 45 minutes per session.
    5. Participants who have experienced dizziness or falls within the past two years.

Exclusion criteria

  • Year 1 (Study A):

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

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

    1. Severe central or peripheral nervous system disorders.
    2. Participants who are blind or deaf.
    3. Individuals who cannot communicate or understand instructions.
    4. Current fractures or significant joint injuries.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

150 participants in 2 patient groups

Traditional vestibule rehabilitation training
Active Comparator group
Description:
The intervention for the control group primarily follows conventional rehabilitation methods but incorporates the computerized training system developed in this project.
Treatment:
Other: Traditional vestibule rehabilitation training
Dual-task vestibule rehabilitation training
Experimental group
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.
Treatment:
Other: Dual-task vestibule rehabilitation training

Trial contacts and locations

1

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Central trial contact

Chen Po-Yin, PhD

Data sourced from clinicaltrials.gov

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