BalanceEarly Phase 1NCT06804512
Intermittent Visual Perturbations to Enhance Balance Training
A Early Phase 1 study testing Visual Occlusion Goggles and Balance Beam Walking in people with Balance, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to determine if intermittent visual perturbations can improve balance training. The investigators will quantify differences in body movement, muscle activity, and beam walking performance during and after practice walking on a balance beam that is 1" high. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- Visual Occlusion Goggles and Balance Beam Walking
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2024to 28 Feb 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-30 years, or 65-89 years.
- Ability to walk independently for 10 minutes continuously.
- Willingness to be randomized to any experimental group and to participate in all aspects of study assessment and intervention
Who cannot join
- -Major cognitive disorder that interferes with independence, based on affirmative response (always/usually/sometimes) to the following question: "As a result of confusion or memory loss, how often do you need assistance with day-to-day activities such as cooking, cleaning, taking medications, driving, or paying bills? Would you say it is 1) Always; 2) Usually; 3) Sometimes; 4) Rarely; or 5) Never".
- Current or recent (within 6 months) lower limb musculoskeletal injury that causes pain during walking or limits walking ability.
- History of neurological injury or disability (including spinal cord injury, stroke, Parkinson's disease, or multiple sclerosis).
- Difficulty communicating with study personnel.
- Current enrollment in any other clinical trial.
- Low vision that cannot be corrected by wearing contact lens. Low vision will be operationally defined as visual acuity less than 20/70 on standard eye chart, or difficulty perform complex walking tasks due to visual conditions affecting accurate navigation around and over obstacles (self-reported or observed by examiner). The goggles to be used in the study do not permit eyeglasses while using them.
- Illiterate or non-English speaking, due to the likelihood of difficulties following protocol instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Florida
Gainesville, Florida, 32611
Daniel P Ferris, Ph.D., 734-834-0379, dferris@bme.ufl.edu
Ethan T Swierski, B.S., 716-399-7761, eswierski@ufl.edu
About this study
The purpose of this research study is to determine if intermittent visual perturbations can improve balance training. The investigators will quantify differences in body movement, muscle activity, and beam walking performance during and after practice walking on a balance beam that is 1" high. The investigators will ask the participants to come to the laboratory twice (2 sessions). The first session will not last more than 3 hours. The second session will not last more than 1 hour and will be two weeks after the first session. In total, the maximum amount of time the participant would be asked to participate is 4 hours.
Read the detailed description
The investigators will recruit both younger (18-30 years of age) and older (65-89 years of age) participants. Half of the subjects will be male and half will be female. All subjects will walk on a treadmill-mounted beam for training and testing with a width determined by the challenge point approach. The beam width will vary for all participants based on the functional abilities of each individual.
When all subjects are consented into the study, the participant will walk across 6 different beams with differing widths laid on the ground. After practicing each width five times, the participant will start on the widest beam (7.6 cm) and walk across it three times. If the participant manages to reach the end of the beam (~3 m) without stepping off, that is a successful traverse. If the participant steps off the beam, it is not a successful traverse. The participant will either proceed to the next beam in the progression or stop at that beam width. That is the participant's starting beam width for the first training session. During the training session, if the participant goes 5 minutes without stepping off the beam, the investigators will move down to the next size beam to increase the participant's challenge level.
All the participants will wear liquid crystal lens goggles (Senaptec) during training. The goggles are sold commercially. The investigators can vary the length of time for unrestricted vision and for occluded vision.
Participants will be randomly assigned to different conditions that vary the parameters of brief intermittent visual perturbations provided by the goggles. One control group will not wear the goggles and one control group will wear the goggles but have no perturbations to their vision. Other groups will have varying lengths of occlusions and/or varying lengths of unobstructed vision. Another two groups will have different levels of light transmission in the goggles intermittently.
Subjects will come to the laboratory twice for training and testing. The first visit will be a pre-test, 30 minutes of training, and a post-test, Two weeks later, the participant will come back for one post-test. For both sessions, participants will wear motion analysis markers, inertial measurement sensors, and electromyography sensors on their body. For pre-tests and post-tests, participants will walk on the treadmill-mounted beam for 5 minutes without wearing the goggles. For training, they will complete three, 10-minute practice sessions walking on the beam for a total of 30 minutes of practice. The speed of the treadmill will be 0.22 m/s. The 30 minutes of training will be broken down into three 10-minute bouts with 5 minutes of rest in between. After completing the training on the first day, subjects will rest for 15 minutes and then complete a 5-minute post-test without the goggles. In the second day of testing 2 weeks later, participants will return to the lab to complete a 5-minute retention test of walking on the balance beam to measure step off errors. During beam walking on the treadmill, subjects will wear a safety harness about their torso that is connected to an overhead support to protect against falls.
Investigators will also assess cross-transfer of the beam walking training, with and without intermittent visual occlusions, to a secondary balance metrics. Participants will complete a single leg stance test before the beam walking pre-test and on the day of retention testing. Subjects will be asked to stand quietly with eyes open while the investigators monitor the time they are able to stand on one leg. Subjects will stand barefoot on the limb of their choice, with the other limb raised so that the raised foot is near but not touching the ankle of their stance limb. Each subject will be asked to focus on a spot on the wall at eye level in front with their vision. Subjects will cross their arms over the chest. Investigators will use a stopwatch to measure the amount of time the subject can stand on one limb. Time will commence when subjects raise their foot off the floor. Time will end when the subject either: (1) uncrossed arms, (2) moved the raised foot, (3) moved the weight-bearing foot to maintain balance, OR (4) 45 seconds elapses. The procedure will be repeated 3 times.
- Conditions
- Balance
- Being tested
- Visual Occlusion Goggles, Balance Beam Walking
- Keywords
- walking balance, gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Occlusion GogglesDevice
Also called Senaptec
The visual occlusion goggles alternate between sight and visual occlusion in a regular and programmable pattern. Based on the electrical properties of the goggles, they are also able to have the tint adjusted instead of blacking out entirely for the occlusion times during the programmed timings.
Balance Beam WalkingBehavioural
Participants will walk on a treadmill mounted balance beam to assess their balance
| Study group | Role | What they receive |
|---|---|---|
| Control - No Goggles | Placebo comparator | Participants will complete the balance beam walking practice without any changes to vision. Receives: Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking |
| Intervention - Goggles Worn But Turned Off | Experimental | Participants will complete the balance beam walking practice while wearing the goggles, but they will not be turned on. Receives: Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking |
| Intervention - Vision for 3.75s and Occlusion for 1.5s | Experimental | Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 3.75s, and the occlusion time will be set to 1.5s for the duration of the practice time. Receives: Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking |
| Intervention - Vision for 7.5s and Occlusion for 0.75s | Experimental | Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 0.75s for the duration of the practice time. Receives: Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking |
| Intervention - Vision for 7.5s and Occlusion for 1.5s | Experimental | Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 1.5s for the duration of the practice time. Receives: Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking |
| Intervention - Vision for 7.5s and Occlusion for 3s | Experimental | Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 3s for the duration of the practice time. Receives: Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking |
| Intervention - Vision for 15s and Occlusion for 1.5s | Experimental | Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 15s, and the occlusion time will be set to 1.5s for the duration of the practice time. Receives: Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking |
| Intervention - Low Visible Light Transmission | Experimental | Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 1.5s for the duration of the practice time. The visible light transmission will be set to a low value around 20% instead of total blackout for the occlusion time. Receives: Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking |
| Intervention - High Visible Light Transmission | Experimental | Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 1.5s for the duration of the practice time. The visible light transmission will be set to a high value around 90% instead of total blackout for the occlusion time. Receives: Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Changes Between Pre and Post-Tests
The primary outcome is a change in balance between the pre-test and post-tests and the pretest and follow-up. For the pre-test, post-test, and follow-up, participants will walk on the treadmill-mounted beam for 5 minutes without wearing the goggles. The pre-test will occur before the training periods begin, the post-test will occur after the training periods, and the follow-up occurs two weeks after the the first training. Step offs and time on the beam is recorded for each trial to make balance comparisons. The step offs and time on the beam used in conjunction to get step offs per minute by dividing step offs by time on the beam. Balance will be measured in step offs per minute.
Measured: Each subject completes the study in two weeks
Secondary outcomes (1)
Balance Changes Between Static, Single Leg Standing on the Day of Training and Follow-up
The secondary outcome will be a change in balance of the single legged balance between the first day and follow-up. Subjects will be asked to stand quietly with eyes open, standing barefoot on the limb of their choice, with the other limb raised so that the raised foot is near but not touching the ankle of their stance limb, looking forward, and with their arms crossed over their chest. This will be done any beam walking is done on both days. The subjects will be timed, ending when they uncross their arms, move their raised foot, move their weight bearing foot, or 45 seconds elapse. This will be done three times on each day. The times will then be compared between the first day of training and the follow-up to look for improvement.
Measured: Each subject completes the study in two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start20 Aug 2024
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of 9 different training conditions. The intervention is walking on a treadmill mounted balance beam while wearing goggles that can perturb vision intermittently.
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804512
- Sponsor's protocol ID
- IRB202302204
- Other IDs
- 2R01NS104772-06A1
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are currently not planning on publishing in an ICMJE journal.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Visual Perturbations to Enhance Balance Training
- ClinicalTrials.gov ID
- NCT06804512
- Acronym / sponsor ID
- IRB202302204
- Conditions
- Balance
- Keywords
- walking balance, gait
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 3 Feb 2025 (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 research study is to determine if intermittent visual perturbations can improve balance training. The investigators will quantify differences in body movement, muscle activity, and beam walking performance during and after practice walking on a balance beam that is 1" high. The investigators will ask the participants to come to the laboratory twice (2 sessions). The first session will not last more than 3 hours. The second session will not last more than 1 hour and will be two weeks after the first session. In total, the maximum amount of time the participant would be asked to participate is 4 hours.
Detailed description
The investigators will recruit both younger (18-30 years of age) and older (65-89 years of age) participants. Half of the subjects will be male and half will be female. All subjects will walk on a treadmill-mounted beam for training and testing with a width determined by the challenge point approach. The beam width will vary for all participants based on the functional abilities of each individual.
When all subjects are consented into the study, the participant will walk across 6 different beams with differing widths laid on the ground. After practicing each width five times, the participant will start on the widest beam (7.6 cm) and walk across it three times. If the participant manages to reach the end of the beam (~3 m) without stepping off, that is a successful traverse. If the participant steps off the beam, it is not a successful traverse. The participant will either proceed to the next beam in the progression or stop at that beam width. That is the participant's starting beam width for the first training session. During the training session, if the participant goes 5 minutes without stepping off the beam, the investigators will move down to the next size beam to increase the participant's challenge level.
All the participants will wear liquid crystal lens goggles (Senaptec) during training. The goggles are sold commercially. The investigators can vary the length of time for unrestricted vision and for occluded vision.
Participants will be randomly assigned to different conditions that vary the parameters of brief intermittent visual perturbations provided by the goggles. One control group will not wear the goggles and one control group will wear the goggles but have no perturbations to their vision. Other groups will have varying lengths of occlusions and/or varying lengths of unobstructed vision. Another two groups will have different levels of light transmission in the goggles intermittently.
Subjects will come to the laboratory twice for training and testing. The first visit will be a pre-test, 30 minutes of training, and a post-test, Two weeks later, the participant will come back for one post-test. For both sessions, participants will wear motion analysis markers, inertial measurement sensors, and electromyography sensors on their body. For pre-tests and post-tests, participants will walk on the treadmill-mounted beam for 5 minutes without wearing the goggles. For training, they will complete three, 10-minute practice sessions walking on the beam for a total of 30 minutes of practice. The speed of the treadmill will be 0.22 m/s. The 30 minutes of training will be broken down into three 10-minute bouts with 5 minutes of rest in between. After completing the training on the first day, subjects will rest for 15 minutes and then complete a 5-minute post-test without the goggles. In the second day of testing 2 weeks later, participants will return to the lab to complete a 5-minute retention test of walking on the balance beam to measure step off errors. During beam walking on the treadmill, subjects will wear a safety harness about their torso that is connected to an overhead support to protect against falls.
Investigators will also assess cross-transfer of the beam walking training, with and without intermittent visual occlusions, to a secondary balance metrics. Participants will complete a single leg stance test before the beam walking pre-test and on the day of retention testing. Subjects will be asked to stand quietly with eyes open while the investigators monitor the time they are able to stand on one leg. Subjects will stand barefoot on the limb of their choice, with the other limb raised so that the raised foot is near but not touching the ankle of their stance limb. Each subject will be asked to focus on a spot on the wall at eye level in front with their vision. Subjects will cross their arms over the chest. Investigators will use a stopwatch to measure the amount of time the subject can stand on one limb. Time will commence when subjects raise their foot off the floor. Time will end when the subject either: (1) uncrossed arms, (2) moved the raised foot, (3) moved the weight-bearing foot to maintain balance, OR (4) 45 seconds elapses. The procedure will be repeated 3 times.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- Participants are randomly assigned to one of 9 different training conditions. The intervention is walking on a treadmill mounted balance beam while wearing goggles that can perturb vision intermittently.
| Arm | Type | Receives |
|---|---|---|
| Control - No Goggles | Placebo comparator | Device: Visual Occlusion Goggles, Behavioral: Balance Beam WalkingParticipants will complete the balance beam walking practice without any changes to vision. |
| Intervention - Goggles Worn But Turned Off | Experimental | Device: Visual Occlusion Goggles, Behavioral: Balance Beam WalkingParticipants will complete the balance beam walking practice while wearing the goggles, but they will not be turned on. |
| Intervention - Vision for 3.75s and Occlusion for 1.5s | Experimental | Device: Visual Occlusion Goggles, Behavioral: Balance Beam WalkingParticipants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 3.75s, and the occlusion time will be set to 1.5s for the duration of the practice time. |
| Intervention - Vision for 7.5s and Occlusion for 0.75s | Experimental | Device: Visual Occlusion Goggles, Behavioral: Balance Beam WalkingParticipants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 0.75s for the duration of the practice time. |
| Intervention - Vision for 7.5s and Occlusion for 1.5s | Experimental | Device: Visual Occlusion Goggles, Behavioral: Balance Beam WalkingParticipants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 1.5s for the duration of the practice time. |
| Intervention - Vision for 7.5s and Occlusion for 3s | Experimental | Device: Visual Occlusion Goggles, Behavioral: Balance Beam WalkingParticipants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 3s for the duration of the practice time. |
| Intervention - Vision for 15s and Occlusion for 1.5s | Experimental | Device: Visual Occlusion Goggles, Behavioral: Balance Beam WalkingParticipants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 15s, and the occlusion time will be set to 1.5s for the duration of the practice time. |
| Intervention - Low Visible Light Transmission | Experimental | Device: Visual Occlusion Goggles, Behavioral: Balance Beam WalkingParticipants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 1.5s for the duration of the practice time. The visible light transmission will be set to a low value around 20% instead of total blackout for the occlusion time. |
| Intervention - High Visible Light Transmission | Experimental | Device: Visual Occlusion Goggles, Behavioral: Balance Beam WalkingParticipants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 1.5s for the duration of the practice time. The visible light transmission will be set to a high value around 90% instead of total blackout for the occlusion time. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18-30 years, or 65-89 years.
- Ability to walk independently for 10 minutes continuously.
- Willingness to be randomized to any experimental group and to participate in all aspects of study assessment and intervention
Key exclusion criteria (7 listed)
- -Major cognitive disorder that interferes with independence, based on affirmative response (always/usually/sometimes) to the following question: "As a result of confusion or memory loss, how often do you need assistance with day-to-day activities such as cooking, cleaning, taking medications, driving, or paying bills? Would you say it is 1) Always; 2) Usually; 3) Sometimes; 4) Rarely; or 5) Never".
- Current or recent (within 6 months) lower limb musculoskeletal injury that causes pain during walking or limits walking ability.
- History of neurological injury or disability (including spinal cord injury, stroke, Parkinson's disease, or multiple sclerosis).
- Difficulty communicating with study personnel.
- Current enrollment in any other clinical trial.
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 |
|---|---|---|
| Visual Occlusion GogglesAlso: SenaptecThe visual occlusion goggles alternate between sight and visual occlusion in a regular and programmable pattern. Based on the electrical properties of the goggles, they are also able to have the tint adjusted instead of blacking out entirely for the occlusion times during the programmed timings. | Device | Control - No Goggles, Intervention - Goggles Worn But Turned Off, Intervention - High Visible Light Transmission, Intervention - Low Visible Light Transmission, Intervention - Vision for 15s and Occlusion for 1.5s, Intervention - Vision for 3.75s and Occlusion for 1.5s, Intervention - Vision for 7.5s and Occlusion for 0.75s, Intervention - Vision for 7.5s and Occlusion for 1.5s, Intervention - Vision for 7.5s and Occlusion for 3s |
| Balance Beam WalkingParticipants will walk on a treadmill mounted balance beam to assess their balance | Behavioural | Control - No Goggles, Intervention - Goggles Worn But Turned Off, Intervention - High Visible Light Transmission, Intervention - Low Visible Light Transmission, Intervention - Vision for 15s and Occlusion for 1.5s, Intervention - Vision for 3.75s and Occlusion for 1.5s, Intervention - Vision for 7.5s and Occlusion for 0.75s, Intervention - Vision for 7.5s and Occlusion for 1.5s, Intervention - Vision for 7.5s and Occlusion for 3s |
Primary outcome
Balance Changes Between Pre and Post-Tests
Time frame: Each subject completes the study in two weeks
The primary outcome is a change in balance between the pre-test and post-tests and the pretest and follow-up. For the pre-test, post-test, and follow-up, participants will walk on the treadmill-mounted beam for 5 minutes without wearing the goggles. The pre-test will occur before the training periods begin, the post-test will occur after the training periods, and the follow-up occurs two weeks after the the first training. Step offs and time on the beam is recorded for each trial to make balance comparisons. The step offs and time on the beam used in conjunction to get step offs per minute by dividing step offs by time on the beam. Balance will be measured in step offs per minute.
1 secondary outcome
Balance Changes Between Static, Single Leg Standing on the Day of Training and Follow-up
Time frame: Each subject completes the study in two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Undecided. We are currently not planning on publishing in an ICMJE journal.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Visual Occlusion Goggles and Balance Beam Walking in people with Balance, run by University of Florida 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel P Ferris, Ph.D. (734-834-0379, dferris@bme.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Changes Between Pre and Post-Tests (time frame: Each subject completes the study in two weeks). 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 10 Feb 2026.