StrokeEarly Phase 1MABNCT05760885
Multisensory Augmentation for Post-stroke Standing Balance
A Early Phase 1 study testing Balance training with sensory augmentation and Balance training in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Many individuals who experience a stroke have problems with their balance. In part, these balance problems may be due to sensory issues. This study will test whether sensory augmentation has the potential to improve post-stroke balance. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Balance training with sensory augmentation and Balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2025to 1 Jan 2027
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of at least 21 years;
- Experience of a stroke at least 6 months prior to participation;
- Berg Balance Scale score less than 52
- Ability to stand independently for at least 1 minute without wearing an AFO or other brace that would preclude delivery of stimulation to the ankle or foot sole
- Provision of informed consent
Who cannot join
- Resting blood pressure higher than 220/110 mm Hg
- History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- Pre-existing neurological disorders or dementia
- Severe visual impairment
- History of DVT or pulmonary embolism within 6 months
- Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
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
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
Jesse C Dean, PhD, 843-792-9566, Jesse.Dean@va.gov
Aaron E Embry, DPT, (843) 792-8198, Aaron.Embry@va.gov
About this study
Official title: Multisensory Augmentation to Improve the Standing Balance of People With Chronic Stroke
Many individuals who experience a stroke have problems with their balance. In part, these balance problems may be due to sensory issues. This study will test whether sensory augmentation has the potential to improve post-stroke balance. Sensory augmentation is a method by which non-invasive vibration is used to enhance the sensory information available to users, which may make it easier to feel where they are and prevent losses of balance.
Read the detailed description
The objective of this study is to design a novel multisensory augmentation approach to improve the control of standing balance in people with chronic stroke. With sensory augmentation, artificial feedback provides the nervous system with information about the dynamic state of the body, which can be used to prevent losses of balance. This clinical trial will investigate whether multisensory augmentation produces sustained balance improvements when applied as a training device. These potential improvements will be assessed by comparing the results of clinical and biomechanical assessments before and after a 10-week balance training program, in which half of the participants will be randomly assigned sensory augmentation.
- Conditions
- Stroke
- Being tested
- Balance training with sensory augmentation, Balance training
- Keywords
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance training with sensory augmentationBehavioural
Participants will complete 20 balance training sessions, in which they are required to keep their balance while standing on a platform that translates under their feet. During training, sensory augmentation will be delivered with an intensity controlled in real-time by their center of pressure motion. The difficulty of the balance training task will progressively increase over successive training sessions.
Balance trainingBehavioural
Participants will complete 20 balance training sessions, in which they are required to keep their balance while standing on a platform that translates under their feet. During training, no sensory stimulation will be delivered. The difficulty of the balance training task will progressively increase over successive training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Sensory Augmentation | Experimental | Participants will receive sensory augmentation in the form of non-invasive vibration, while balance training is performed as described below. Receives: Behavioral: Balance training with sensory augmentation |
| Control | Active comparator | Participants will receive balance training, without any sensory augmentation. Receives: Behavioral: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale score change
A standard clinical assessment to measure balance performance during various functional tasks
Measured: Before and after a 10-week period of balance training
Secondary outcomes (4)
Limits of Stability score (paretic direction)
A standard assessment of how far participants are willing and able to shift their weight toward the paretic leg while standing
Measured: Before and after a 10-week period of balance training
Limits of Stability score (non-paretic direction)
A standard assessment of how far participants are willing and able to shift their weight toward the non-paretic leg while standing
Measured: Before and after a 10-week period of balance training
Mediolateral center of pressure displacement
A measure of sideways sway, which will be quantified as participants stand on a platform that translates sideways, challenging participant balance
Measured: Before and after a 10-week period of balance training
Mediolateral center of pressure velocity
A measure of sideways sway, which will be quantified as participants stand on a platform that translates sideways, challenging participant balance
Measured: Before and after a 10-week period of balance training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start14 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either a Control or an Experimental group. The Experimental group will receive sensory augmentation during balance training, while the Control group will not.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jesse C. Dean, PhD, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760885
- Sponsor's protocol ID
- A4545-R
- Other IDs
- I01RX004545
- Acronym
- MAB
- Status last verified
- Dec 2025
- First submitted
- 23 Feb 2023
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified data that contains no protected participant information. This data will be shared in the form of pre-prints and through online servers upon study results publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisensory Augmentation to Improve the Standing Balance of People With Chronic Stroke
- ClinicalTrials.gov ID
- NCT05760885
- Acronym / sponsor ID
- MAB / A4545-R
- Conditions
- Stroke
- Keywords
- Stroke
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 8 Mar 2023 (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.
Many individuals who experience a stroke have problems with their balance. In part, these balance problems may be due to sensory issues. This study will test whether sensory augmentation has the potential to improve post-stroke balance. Sensory augmentation is a method by which non-invasive vibration is used to enhance the sensory information available to users, which may make it easier to feel where they are and prevent losses of balance.
Detailed description
The objective of this study is to design a novel multisensory augmentation approach to improve the control of standing balance in people with chronic stroke. With sensory augmentation, artificial feedback provides the nervous system with information about the dynamic state of the body, which can be used to prevent losses of balance. This clinical trial will investigate whether multisensory augmentation produces sustained balance improvements when applied as a training device. These potential improvements will be assessed by comparing the results of clinical and biomechanical assessments before and after a 10-week balance training program, in which half of the participants will be randomly assigned sensory augmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either a Control or an Experimental group. The Experimental group will receive sensory augmentation during balance training, while the Control group will not.
| Arm | Type | Receives |
|---|---|---|
| Sensory Augmentation | Experimental | Behavioral: Balance training with sensory augmentationParticipants will receive sensory augmentation in the form of non-invasive vibration, while balance training is performed as described below. |
| Control | Active comparator | Behavioral: Balance trainingParticipants will receive balance training, without any sensory augmentation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of at least 21 years;
- Experience of a stroke at least 6 months prior to participation;
- Berg Balance Scale score less than 52
- Ability to stand independently for at least 1 minute without wearing an AFO or other brace that would preclude delivery of stimulation to the ankle or foot sole
- Provision of informed consent
Key exclusion criteria (6 listed)
- Resting blood pressure higher than 220/110 mm Hg
- History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- Pre-existing neurological disorders or dementia
- Severe visual impairment
- History of DVT or pulmonary embolism within 6 months
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 |
|---|---|---|
| Balance training with sensory augmentationParticipants will complete 20 balance training sessions, in which they are required to keep their balance while standing on a platform that translates under their feet. During training, sensory augmentation will be delivered with an intensity controlled in real-time by their center of pressure motion. The difficulty of the balance training task will progressively increase over successive training sessions. | Behavioural | Sensory Augmentation |
| Balance trainingParticipants will complete 20 balance training sessions, in which they are required to keep their balance while standing on a platform that translates under their feet. During training, no sensory stimulation will be delivered. The difficulty of the balance training task will progressively increase over successive training sessions. | Behavioural | Control |
Primary outcome
Berg Balance Scale score change
Time frame: Before and after a 10-week period of balance training
A standard clinical assessment to measure balance performance during various functional tasks
4 secondary outcomes
Limits of Stability score (paretic direction)
Time frame: Before and after a 10-week period of balance training
Limits of Stability score (non-paretic direction)
Time frame: Before and after a 10-week period of balance training
Mediolateral center of pressure displacement
Time frame: Before and after a 10-week period of balance training
Mediolateral center of pressure velocity
Time frame: Before and after a 10-week period of balance training
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 6 Jan 2026.
- Individual participant dataSharing planned: Yes. We plan to share de-identified data that contains no protected participant information. This data will be shared in the form of pre-prints and through online servers upon study results publication.
Related trials for Stroke
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Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
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Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
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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.
Jesse C. Dean, PhD principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
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 Balance training with sensory augmentation and Balance training in people with Stroke, run by VA Office of Research and Development 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 5 inclusion and 6 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 6 Jan 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. 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 Jesse C Dean, PhD ((843) 792-9566, Jesse.Dean@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale score change (time frame: Before and after a 10-week period of balance training). 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 6 Jan 2026.