- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04213521
Visual Dependence and Multisensory Balance Exercise
Visual Dependence and Multisensory Balance Exercise for Elderly
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Older people often find it difficult to maintain balance with their eyes closed, which emphasizes the importance of vision. The greater influence of vision on orientation and balance has been observed by manipulating static and dynamic visual cues-for instance, tilting the frame of reference or moving visual scenes. Older people-particularly those prone to falls-have been reported to make significantly greater errors in subjective visual verticality and exhibit greater sway and continued center of gravity oscillation during and following visual disturbances. They also adopted hip strategies to restore balance in response to visual perturbation, indicating that they were unstable in the event of visual disturbance. These results indicate that older people may have higher levels of visual dependence than younger adults.
The underlying mechanism of visual dependence remains unclear. Visual dependence is considered a form of sensory reweighting deficit. In a situation of sensory conflict, the central nervous system must first recognize the discrepancy and reduce the weighting (suppress) of the inaccurate input while increasing the weighting of the input from the sensory systems that are deemed to provide more reliable information. This complex process of sensory organization is termed multiple-sensory reweighting and is vital in maintaining balance and orientation in a continuously changing and complex environment.
Studies have suggested that visual dependence could benefit from promoting desensitization and increased visual motion tolerance through visual adaptation and habituation exercises in vestibular rehabilitation. This may be because the majority of visually dependent adults have the comorbid symptom of visual vertigo. However, according to the National Audit Survey in the United States, one-third of patients with vestibular disorders and visual dependence lack signs and symptoms of dizziness or vertigo. Recent evidence has demonstrated that healthy older adults with greater levels of visual dependence did not have dizziness; therefore, it is unclear whether visual adaptation exercises can effectively reduce the degree of visual dependence in such people. However, visual dependence can be considered as a sensory reweighting deficit; therefore, multisensory balance training with manipulation of the visual, vestibular, and proprioceptive inputs could be an alternative for decreasing visual dependence through improving the integration and reweighting of sensory systems. In fact, multiple studies have documented that multisensory balance training improves mobility and balance in older adults with instability or a history of falls; however, few have investigated its effectiveness on visual dependence and in healthy elderly people. Therefore, the aim of the study was to investigate the effectiveness of multisensory balance training on the levels of visual dependence and sensory organization capacity in older adults.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan, 110
- Taipei Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1) age more than 60 years
- 2) able to walk continuously for 10 meters independently without aid
- 3) normal cognitive function with a Mini-Mental State Examination score more than 24
- 4) able to follow oral commands.
Exclusion Criteria:
- any medical condition or recent injury that could affect the assessment of balance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Multisensory balance training group
The participants in the multisensory balance training group were provided with multiple-sensory balance exercises using visual, proprioceptive, and vestibular manipulations.
The exercises involved movements of the eye, head, and body to stimulate the vestibular system-postural control exercises in different positions (feet together, tandem stance, and one leg stance), use of a soft surface to reduce the proprioceptive inputs, and exercises with closed eyes to deprive them of visual cues.
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Multisensory balance training describes a balance exercise incorporating individual sensory manipulation of vision, vestibular, proprioception and sensory integration.
such as static and dynamic standing balance without altered sensory inputs.
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Active Comparator: Conventional balance training group
The participants in the Conventional balance training group performed conventional balance exercises, such as static and dynamic standing balance without altered sensory inputs.
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such as static and dynamic standing balance without altered sensory inputs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rod and Disc Test
Time Frame: Change from baseline to post-intervention at 4-8 weeks
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It is a computerized test which measures levels of visual dependence.
Greater errors from true vertical indicates the greater levels of visual dependence.
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Change from baseline to post-intervention at 4-8 weeks
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Modified clinical test of sensory interaction in balance
Time Frame: Change from baseline to post-intervention at 4-8 weeks
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It assess the contribution of the visual, somatosensory, and vestibular systems to postural control.
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Change from baseline to post-intervention at 4-8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chair sit and reach test
Time Frame: Change from baseline to post-intervention at 4-8 weeks
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It measures lower limb flexibility.
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Change from baseline to post-intervention at 4-8 weeks
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Five times sit to stand test
Time Frame: Change from baseline to post-intervention at 4-8 weeks
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It measures lower limb strength.
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Change from baseline to post-intervention at 4-8 weeks
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Berg balance scale
Time Frame: Change from baseline to post-intervention at 4-8 weeks
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It is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks.
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
A total score of 56 indicates functional balance and but less than 45 indicates individuals may be at greater risk of falling.
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Change from baseline to post-intervention at 4-8 weeks
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The Activities specific Balance Confidence Scale
Time Frame: Change from baseline to post-intervention at 4-8 weeks
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It measures balance confidence level and contains 16 items scored on a range from 0% to 100%.
The score of 0 indicates no confidence and 100 indicates full confidence.
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Change from baseline to post-intervention at 4-8 weeks
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Timed up and go test
Time Frame: Change from baseline to post-intervention at 4-8 weeks
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It measures functional mobility.
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Normal healthy elderly usually complete the task in 10 seconds or less.
Very frail or weak elderly with poor mobility may take 2 minutes or more.
A score of more than or equal to 14 seconds has been shown to indicate high risk of falls.
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Change from baseline to post-intervention at 4-8 weeks
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10 meters walk test
Time Frame: Change from baseline to post-intervention at 4-8 weeks
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It is a performance measure used to assess walking speed and walking capacity in meters per second over a short distance.
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Change from baseline to post-intervention at 4-8 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mini mental state examination
Time Frame: During screening
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It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive function.
Any score of 24 or more (out of 30) indicates a normal cognition.
Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
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During screening
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shu-Chun Lee, PhD, Taipei Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- N20180725
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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