Visual DependenceNCT04213521
Visual Dependence and Multisensory Balance Exercise
A study testing Multisensory balance exercise and Conventional balance exercise in people with Visual Dependence and Multisensory, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The study aimed to investigate the effectiveness of multisensory balance training on the levels of visual dependence and sensory organization capacity in community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Dependence, Multisensory, Exercise
- What is being tested?
- Multisensory balance exercise and Conventional balance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2019to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- any medical condition or recent injury that could affect the assessment of balance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visual Dependence and Multisensory Balance Exercise for Elderly
The study aimed to investigate the effectiveness of multisensory balance training on the levels of visual dependence and sensory organization capacity in community-dwelling older adults. Participants in the experimental group received multisensory balance training while those in the control group received conventional balance training without sensory manipulation.
Read the 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.
- Conditions
- Visual Dependence, Multisensory, Exercise, Training, Balance, Elderly
- Being tested
- Multisensory balance exercise, Conventional balance exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory balance exerciseOther
Multisensory balance training describes a balance exercise incorporating individual sensory manipulation of vision, vestibular, proprioception and sensory integration.
Conventional balance exerciseOther
such as static and dynamic standing balance without altered sensory inputs.
| Study group | Role | What they receive |
|---|---|---|
| Multisensory balance training group | Experimental | 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. Receives: Other: Multisensory balance exercise; Other: Conventional balance exercise |
| Conventional balance training group | Active comparator | The participants in the Conventional balance training group performed conventional balance exercises, such as static and dynamic standing balance without altered sensory inputs. Receives: Other: Conventional balance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rod and Disc Test
It is a computerized test which measures levels of visual dependence. Greater errors from true vertical indicates the greater levels of visual dependence.
Measured: Change from baseline to post-intervention at 4-8 weeks
Modified clinical test of sensory interaction in balance
It assess the contribution of the visual, somatosensory, and vestibular systems to postural control.
Measured: Change from baseline to post-intervention at 4-8 weeks
Secondary outcomes (6)
Chair sit and reach test
It measures lower limb flexibility.
Measured: Change from baseline to post-intervention at 4-8 weeks
Five times sit to stand test
It measures lower limb strength.
Measured: Change from baseline to post-intervention at 4-8 weeks
Berg balance scale
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.
Measured: Change from baseline to post-intervention at 4-8 weeks
The Activities specific Balance Confidence Scale
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.
Measured: Change from baseline to post-intervention at 4-8 weeks
Timed up and go test
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.
Measured: Change from baseline to post-intervention at 4-8 weeks
10 meters walk test
It is a performance measure used to assess walking speed and walking capacity in meters per second over a short distance.
Measured: Change from baseline to post-intervention at 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start1 Mar 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual DependenceStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Chun Lee, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213521
- Sponsor's protocol ID
- N20180725
- Status last verified
- Jul 2018
- First submitted
- 19 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: would like to share if other researchers officially request
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Dependence and Multisensory Balance Exercise for Elderly
- ClinicalTrials.gov ID
- NCT04213521
- Acronym / sponsor ID
- N20180725
- Conditions
- Visual Dependence, Multisensory, Exercise, Training, Balance, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to investigate the effectiveness of multisensory balance training on the levels of visual dependence and sensory organization capacity in community-dwelling older adults. Participants in the experimental group received multisensory balance training while those in the control group received conventional balance training without sensory manipulation.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multisensory balance training group | Experimental | Other: Multisensory balance exercise, Other: Conventional balance exerciseThe 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. |
| Conventional balance training group | Active comparator | Other: Conventional balance exerciseThe participants in the Conventional balance training group performed conventional balance exercises, such as static and dynamic standing balance without altered sensory inputs. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- any medical condition or recent injury that could affect the assessment of balance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multisensory balance exerciseMultisensory balance training describes a balance exercise incorporating individual sensory manipulation of vision, vestibular, proprioception and sensory integration. | Other | Multisensory balance training group |
| Conventional balance exercisesuch as static and dynamic standing balance without altered sensory inputs. | Other | Conventional balance training group, Multisensory balance training group |
Primary outcome
Rod and Disc Test
Time frame: Change from baseline to post-intervention at 4-8 weeks
It is a computerized test which measures levels of visual dependence. Greater errors from true vertical indicates the greater levels of visual dependence.
Modified clinical test of sensory interaction in balance
Time frame: Change from baseline to post-intervention at 4-8 weeks
It assess the contribution of the visual, somatosensory, and vestibular systems to postural control.
6 secondary outcomes
Chair sit and reach test
Time frame: Change from baseline to post-intervention at 4-8 weeks
Five times sit to stand test
Time frame: Change from baseline to post-intervention at 4-8 weeks
Berg balance scale
Time frame: Change from baseline to post-intervention at 4-8 weeks
The Activities specific Balance Confidence Scale
Time frame: Change from baseline to post-intervention at 4-8 weeks
Timed up and go test
Time frame: Change from baseline to post-intervention at 4-8 weeks
10 meters walk test
Time frame: Change from baseline to post-intervention at 4-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Individual participant dataSharing planned: Yes. would like to share if other researchers officially request
Related trials for Visual Dependence
Recruiting
Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy
Neuropathy, Ataxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Chun Lee, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory balance exercise and Conventional balance exercise in people with Visual Dependence and Multisensory, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rod and Disc Test (time frame: Change from baseline to post-intervention at 4-8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.