AgingNCT05117463
Postural Control During Concurrent Cognitive Tasks During Optic Flow Stimulation
An observational study of Aging and Postural Balance, run by Chia-Cheng Lin, PhD, PT, MSPT at 1 site in United States.
Trial summary
The purpose of this study is to investigate brain activity during current visual and auditory tasks for balance control. The participants will perform cognitive, gait, and balance measures before the data collection to exclude people with neurological disorders. Read more about this study
- Who is it for?
- Ages 25 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Postural Balance
- What is being tested?
- Optic Flow Stimulation and Auditory Reaction Time
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 28 Feb 2025
- Phase
- Observational
- 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 25 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy younger adults: aged between 25-45 years old Healthy older adults: aged between 65-85 years old Older adults with risks of falls: aged between 65-85 years old
Who may be able to join
- must not have any vestibular, orthopedic or neurological disorders, knee or hip replacements, reports of dizziness, low visual acuity (corrective vision less than 20/40) or require the use of an assistive device for ambulation.
- Right-handed
Who cannot join
- Healthy group: have a low fall risk profile based on current available clinical balance and gait assessment tools, such as the MiniBEST and STEADI fall risk self-assessment tool and normal cognitive status using the Montreal Cognitive Assessment (MoCA > 26/30)
- Fall risk group: other medical issues rather than balance problems
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Chiacheng Lin, PhD, 252-744-6231, linch14@ecu.edu
About this study
Official title: Characterizing Brain Activation and Postural Response During Concurrent Cognitive Tasks in the Presence of Optic Flow Stimulation: A Functional Near-Infrared Spectroscopy Study
The purpose of this study is to investigate brain activity during current visual and auditory tasks for balance control. The participants will perform cognitive, gait, and balance measures before the data collection to exclude people with neurological disorders. The participants will wear VR headset which provides visual tasks. The participants will need to maintain balance while performing concurrent visual and auditory tasks. The brain activities, reaction time, and eye-tracking data will be collected during doing our experimental tasks.
Read the detailed description
Virtual reality (VR), defined as an interactive system including computers and media peripherals, creates an environment similar to a real-world and also provides audio and video feedback to users. Recently, the virtual reality technology is able to make a headset displaying 360 degrees VR environment and locate the headset in the space. This improvement of VR technology significantly reduces the cost of VR equipment and enhances the application of VR technology in the field of balance assessment and treatment.
Optic flow (OF) has been used to study the effect of visual input on balance control. Most of the studies displayed OF on a screen rather than using 360 degrees visual field environment. Therefore, the subjects could obtain reference inputs for balance adjustment. The new VR headset makes it possible to play OF in a 360-degree visual field in which the subject will not able to obtain any reference inputs rather than using somatosensory and/or vestibular systems. It is unclear how the effect of aging and attention relocation affects postural control with concurrent visual and auditory attention tasks. In this study, fNIRS will be used to detect the brain activity of healthy adults in the prefrontal and temporal-parietal junction as they complete concurrent cognitive and visual tasks displayed by a VR headset. This work will focus on age and test positions (sitting vs standing). As age can play a role in brain activation levels, the investigators will compare results among younger adults (25-35 years), older adults (65-85 years), and older adults with the risk of falls. All the subjects will undergo concurrent auditory reaction time tasks and visual tracking tasks. The investigators will compare the brain images from the test conditions between the age groups and investigate if brain activity differs during the performance of reaction time tasks and visual tacking tasks. The goal of this study is to examine the effect of concurrent visual and auditory tasks on brain activation and postural control.
- Conditions
- Aging, Postural Balance
- Being tested
- Optic Flow Stimulation, Auditory Reaction Time
- Keywords
- Aging, Functional Near-Infrared Spectroscopy, Optic Flow, Balance Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic Flow StimulationOther
The optic flow will be displayed at different speeds. The subject will need to look at the center of the optic flow.
Auditory Reaction TimeOther
Two different pitches of tones will be played. The participants will need to press a button on the right or left hand based on the pitch of the tone.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Younger Adults | Healthy younger adults without any neurological and orthopedic disorders. Receives: Other: Optic Flow Stimulation; Other: Auditory Reaction Time | |
| Healthy Older Adults | Healthy older adults without any neurological and orthopedic disorders. Receives: Other: Optic Flow Stimulation; Other: Auditory Reaction Time | |
| Older Adults with higher risk of falls | Older adults with a history of falls or poor balance based on the clinical balance and gait assessment. Receives: Other: Optic Flow Stimulation; Other: Auditory Reaction Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activation of region of interest
The functional Near-Infrared Spectroscopy (fNIRS) will be used to collect the brain activity in the region of interest. The fNIRS is a non-invasive neuroimaging technology that has been used to study brain activation during dynamic conditions.
Measured: 30 minutes
Postural Sway
A forceplate will be used to measure the postural sway during static standing conditions.
Measured: 30 minutes
Reaction time
The auditory choice reaction time task will be used to measure the reaction time. The participant will need to push a button on right hand when hearing a lower pitch of tone and left hand when hearing a higher pitch of tone.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Jul 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia-Cheng Lin, PhD, PT, MSPT
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Chia-Cheng Lin, PhD, PT, MSPT, East Carolina University
- Investigators
- Brain Sylcott, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117463
- Sponsor's protocol ID
- Interventional
- Other IDs
- R21AG070300
- Status last verified
- Aug 2024
- First submitted
- 14 Oct 2021
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hinderaker M, Sylcott B, Williams K, Lin CC. Aging Affects the Ability to Process the Optic Flow Stimulations: A Functional Near-Infrared Spectrometry Study. J Mot Behav. 2020;52(4):466-473. doi: 10.1080/00222895.2019.1645639. Epub 2019 Jul 30.
PubMed 31361196Berard JR, Fung J, McFadyen BJ, Lamontagne A. Aging affects the ability to use optic flow in the control of heading during locomotion. Exp Brain Res. 2009 Apr;194(2):183-90. doi: 10.1007/s00221-008-1685-1. Epub 2009 Jan 13.
PubMed 19139863Dijkstra BW, Bekkers EMJ, Gilat M, de Rond V, Hardwick RM, Nieuwboer A. Functional neuroimaging of human postural control: A systematic review with meta-analysis. Neurosci Biobehav Rev. 2020 Aug;115:351-362. doi: 10.1016/j.neubiorev.2020.04.028. Epub 2020 May 11.
PubMed 32407735Lin CC, Barker JW, Sparto PJ, Furman JM, Huppert TJ. Functional near-infrared spectroscopy (fNIRS) brain imaging of multi-sensory integration during computerized dynamic posturography in middle-aged and older adults. Exp Brain Res. 2017 Apr;235(4):1247-1256. doi: 10.1007/s00221-017-4893-8. Epub 2017 Feb 14.
PubMed 28197672Hoppes CW, Sparto PJ, Whitney SL, Furman JM, Huppert TJ. Functional near-infrared spectroscopy during optic flow with and without fixation. PLoS One. 2018 Mar 7;13(3):e0193710. doi: 10.1371/journal.pone.0193710. eCollection 2018.
PubMed 29513720
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Brain Activation and Postural Response During Concurrent Cognitive Tasks in the Presence of Optic Flow Stimulation: A Functional Near-Infrared Spectroscopy Study
- ClinicalTrials.gov ID
- NCT05117463
- Acronym / sponsor ID
- Interventional
- Conditions
- Aging, Postural Balance
- Keywords
- Aging, Functional Near-Infrared Spectroscopy, Optic Flow, Balance Control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Chia-Cheng Lin, PhD, PT, MSPTUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 11 Nov 2021 (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 purpose of this study is to investigate brain activity during current visual and auditory tasks for balance control. The participants will perform cognitive, gait, and balance measures before the data collection to exclude people with neurological disorders. The participants will wear VR headset which provides visual tasks. The participants will need to maintain balance while performing concurrent visual and auditory tasks. The brain activities, reaction time, and eye-tracking data will be collected during doing our experimental tasks.
Detailed description
Virtual reality (VR), defined as an interactive system including computers and media peripherals, creates an environment similar to a real-world and also provides audio and video feedback to users. Recently, the virtual reality technology is able to make a headset displaying 360 degrees VR environment and locate the headset in the space. This improvement of VR technology significantly reduces the cost of VR equipment and enhances the application of VR technology in the field of balance assessment and treatment.
Optic flow (OF) has been used to study the effect of visual input on balance control. Most of the studies displayed OF on a screen rather than using 360 degrees visual field environment. Therefore, the subjects could obtain reference inputs for balance adjustment. The new VR headset makes it possible to play OF in a 360-degree visual field in which the subject will not able to obtain any reference inputs rather than using somatosensory and/or vestibular systems. It is unclear how the effect of aging and attention relocation affects postural control with concurrent visual and auditory attention tasks. In this study, fNIRS will be used to detect the brain activity of healthy adults in the prefrontal and temporal-parietal junction as they complete concurrent cognitive and visual tasks displayed by a VR headset. This work will focus on age and test positions (sitting vs standing). As age can play a role in brain activation levels, the investigators will compare results among younger adults (25-35 years), older adults (65-85 years), and older adults with the risk of falls. All the subjects will undergo concurrent auditory reaction time tasks and visual tracking tasks. The investigators will compare the brain images from the test conditions between the age groups and investigate if brain activity differs during the performance of reaction time tasks and visual tacking tasks. The goal of this study is to examine the effect of concurrent visual and auditory tasks on brain activation and postural control.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Younger Adults | – | Other: Optic Flow Stimulation, Other: Auditory Reaction TimeHealthy younger adults without any neurological and orthopedic disorders. |
| Healthy Older Adults | – | Other: Optic Flow Stimulation, Other: Auditory Reaction TimeHealthy older adults without any neurological and orthopedic disorders. |
| Older Adults with higher risk of falls | – | Other: Optic Flow Stimulation, Other: Auditory Reaction TimeOlder adults with a history of falls or poor balance based on the clinical balance and gait assessment. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy younger adults: aged between 25-45 years old Healthy older adults: aged between 65-85 years old Older adults with risks of falls: aged between 65-85 years old
Key inclusion criteria (2 listed)
- must not have any vestibular, orthopedic or neurological disorders, knee or hip replacements, reports of dizziness, low visual acuity (corrective vision less than 20/40) or require the use of an assistive device for ambulation.
- Right-handed
Key exclusion criteria (2 listed)
- Healthy group: have a low fall risk profile based on current available clinical balance and gait assessment tools, such as the MiniBEST and STEADI fall risk self-assessment tool and normal cognitive status using the Montreal Cognitive Assessment (MoCA > 26/30)
- Fall risk group: other medical issues rather than balance problems
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 |
|---|---|---|
| Optic Flow StimulationThe optic flow will be displayed at different speeds. The subject will need to look at the center of the optic flow. | Other | Healthy Older Adults, Healthy Younger Adults, Older Adults with higher risk of falls |
| Auditory Reaction TimeTwo different pitches of tones will be played. The participants will need to press a button on the right or left hand based on the pitch of the tone. | Other | Healthy Older Adults, Healthy Younger Adults, Older Adults with higher risk of falls |
Primary outcome
Brain activation of region of interest
Time frame: 30 minutes
The functional Near-Infrared Spectroscopy (fNIRS) will be used to collect the brain activity in the region of interest. The fNIRS is a non-invasive neuroimaging technology that has been used to study brain activation during dynamic conditions.
Postural Sway
Time frame: 30 minutes
A forceplate will be used to measure the postural sway during static standing conditions.
Reaction time
Time frame: 30 minutes
The auditory choice reaction time task will be used to measure the reaction time. The participant will need to push a button on right hand when hearing a lower pitch of tone and left hand when hearing a higher pitch of tone.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Background: PubMed 31361196Hinderaker M, Sylcott B, Williams K, Lin CC. Aging Affects the Ability to Process the Optic Flow Stimulations: A Functional Near-Infrared Spectrometry Study. J Mot Behav. 2020;52(4):466-473. doi: 10.1080/00222895.2019.1645639. Epub 2019 Jul 30.
- Background: PubMed 19139863Berard JR, Fung J, McFadyen BJ, Lamontagne A. Aging affects the ability to use optic flow in the control of heading during locomotion. Exp Brain Res. 2009 Apr;194(2):183-90. doi: 10.1007/s00221-008-1685-1. Epub 2009 Jan 13.
- Background: PubMed 32407735Dijkstra BW, Bekkers EMJ, Gilat M, de Rond V, Hardwick RM, Nieuwboer A. Functional neuroimaging of human postural control: A systematic review with meta-analysis. Neurosci Biobehav Rev. 2020 Aug;115:351-362. doi: 10.1016/j.neubiorev.2020.04.028. Epub 2020 May 11.
- Results publication: PubMed 28197672Lin CC, Barker JW, Sparto PJ, Furman JM, Huppert TJ. Functional near-infrared spectroscopy (fNIRS) brain imaging of multi-sensory integration during computerized dynamic posturography in middle-aged and older adults. Exp Brain Res. 2017 Apr;235(4):1247-1256. doi: 10.1007/s00221-017-4893-8. Epub 2017 Feb 14.
- Results publication: PubMed 29513720Hoppes CW, Sparto PJ, Whitney SL, Furman JM, Huppert TJ. Functional near-infrared spectroscopy during optic flow with and without fixation. PLoS One. 2018 Mar 7;13(3):e0193710. doi: 10.1371/journal.pone.0193710. eCollection 2018.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Not yet recruiting
Effects of Cannabidiol on Memory and Attention in Adults Aged 60-70: A Pilot Study
Healthy Aging, Cognition
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruitingObservational study
MCR Syndrome in Quebec : Results From NuAge Study
Motoric Cognitive Risk Syndrome, Aging Disorder
Active, not recruitingObservational study
Passive Limb Movement: A Tool to Assess Vascular Health and Guide Rehabilitation
Aging, Cardiovascular Disease
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.
Brain Sylcott, PhD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Postural Balance, run by Chia-Cheng Lin, PhD, PT, MSPT at 1 site in United States.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Sylcott, PhD (252-737-4652, sylcottb15@ecu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activation of region of interest (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05117463, which also lists 5 linked publications.
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 27 Aug 2024.