StrokeNEUROBALANCENCT07113041
Neuromodulation-Enhanced Use of RObotic BALANCE Training to Improve Balance Function in Individuals With Stroke
A study testing Combined (Robotic balance training and high-definition transcranial direct current stimulation) in people with Stroke and Stroke (CVA) or Transient Ischemic Attack, run by Kessler Foundation at 1 site in United States.
Trial summary
Our proposed study, "NEUROBALANCE Stroke,"; aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance function and postural control in individuals with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Stroke (CVA) or Transient Ischemic Attack, Stroke Ischemic
- What is being tested?
- Combined (Robotic balance training and high-definition transcranial direct current stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 31 Aug 2029
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-75 years
- Diagnosed with a cortical/subcortical ischemic stroke at least 6 months before the screening, as confirmed by the neurological exam or an MRI.
- Have complaints of impaired balance and poor postural control determined by a BBS score of ≤50.
- Ability to stand upright with or without support for at least 20 seconds
- Ability to walk with or without a walking aid for at least ten meters
- Not planning to change medication in the next four months
- Minimum Cognitive Ability to understand the verbal instructions and comply with the study procedures, as determined by the University of California, San Diego, Brief Assessment of Capacity to Consent Instrument (UBACC).
Who cannot join
- Currently undergoing any regular physical therapy program or research studies focusing on balance functions.
- Having a brainstem stroke.
- Contraindication for MRI scan (presence of metal implants, claustrophobia)
- Affected by the peripheral nerve injury, neuromuscular conditions, or orthopedic issues of lower limbs before stroke, or have any persistent pain or difficulty maintaining blood pressure while upright.
- Have a scalp or skin condition (e.g., psoriasis or eczema) * on the scalp near the stimulation site
- Having severe visual impairment (e.g., spatial neglect) or hearing problems that may affect study compliance
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- Any other neurological injury or psychiatric conditions (e.g., severe anxiety or schizophrenia etc.)
- Contraindications to MRI, including the presence of non-titanium metallic implants, claustrophobia, etc.
- Not be pregnant or thinking of becoming pregnant
- Diagnosed with alcohol or substance abuse in the last 3 years
- Contraindications to TMS, including the presence of metallic implants in the head and a history of seizures or medication-resistant epilepsy or ongoing use of anti-seizure/seizure threshold-lowering medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kathleen Goworek, B.S. contact
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Vikram Shenoy Handiru, PhD, 9733243578, vshenoy@kesslerfoundation.org
About this study
Our proposed study, "NEUROBALANCE Stroke,"; aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance function and postural control in individuals with chronic stroke. The study will recruit 45 participants who have had a stroke at least 6 months before enrolment and experience persistent balance and gait deficits. Participants will be randomized into three groups: (1) robotic balance training with active brain stimulation, (2) robotic balance training with sham brain stimulation, and (3) standard-of-care rehabilitation.
The study will involve 15 training sessions over 5 weeks, with assessments conducted at baseline, post-training, and two months post-training to evaluate balance recovery and retention. The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function. Additionally, participant feedback on brain stimulation and exercise engagement will be collected to inform future studies.
The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies.
- Conditions
- Stroke, Stroke (CVA) or Transient Ischemic Attack, Stroke Ischemic, Stroke Gait Rehabilitation, Balance Deficits
- Being tested
- Combined (Robotic balance training and high-definition transcranial direct current stimulation), Standard of Care Balance Training
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined (Robotic balance training and high-definition transcranial direct current stimulation)Device
The robotic platform will train the participants to maintain dynamic balance in the sagittal and transverse planes (mediolateral and anterior-posterior directions) and engage in core stability and trunk control with seated balance exercises. In addition, high-definition transcranial direct current stimulation (HD-tDCS) will be used as an adjuvant to robotic balance training by priming the corticospinal circuits.
Standard of Care Balance TrainingOther
Participants in this group will receive a standard-of-care balance training (dose matched to the experimental group) administered by the Physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| RBT + Active HD-tDCS Group | Experimental | Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using individual MRI-guided neuronavigated transcranial magnetic stimulation (nTMS), and the stimulation will be turned ON for 20 minutes. Receives: Device: Combined (Robotic balance training and high-definition transcranial direct current stimulation) |
| RBT + Sham HD-tDCS Group | Sham comparator | Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using individual MRI-guided neuronavigated transcranial magnetic stimulation (nTMS), and the stimulation will be turned ON transiently for 30 s to provide a sensation of stimulation. Receives: Device: Combined (Robotic balance training and high-definition transcranial direct current stimulation) |
| SOC Control Group | Other | The standard of care (SOC) control group participants will perform dose-matched conventional physical therapy exercises delivered by a trained PT. Receives: Other: Standard of Care Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
A widely used outcome measure of static standing balance function (Newstead et al., 2005), categorized under the 'Activity' subsection of ICF domain. BBS scores range from 0 to 56 (the higher, the better). The change in BBS scores from baseline to 4 weeks post-training will be the primary endpoint.
Measured: Baseline, post 5-week training, 2-month follow-up
Secondary outcomes (9)
Functional Gait Assessment (FGA)
To assess dynamic balance during walking, unlike BBS, it is not prone to the ceiling effect(Van Bloemendaal et al., 2019). FGA will be used as the secondary outcome measure of balance function and gait. FGA comes under the ICF domains of 'Activity' and 'Body Function.'
Measured: Baseline, post 5-week training, and 2-month follow-up
Mini Balance Evaluation Systems Test (MBT)
To identify the risk of falls (Yingyongyudha et al., 2016) with a high internal consistency with BBS and similar advantage of FGA, i.e., no ceiling effect. MBT will be used as the secondary endpoint of the balance function.
Measured: Baseline, post 5-week training, and 2-month follow-up
Trunk Impairment Scale (TIS)
To estimate the trunk motor impairment(Verheyden et al., 2004). The scale ranges from 0 to 23 and assesses static and dynamic postural control.
Measured: Baseline, post 5-week training, and 2-month follow-up
Center of Pressure (COP) Displacement
To evaluate the body sway in response to the perturbations of the posturography platform.
Measured: Baseline, post 5-week training, and 2-month follow-up
TMS-evoked EEG Potentials (TEP)
A neurophysiological outcome measure of cortical reactivity. TEPs can directly measure cortical reactivity without being affected by the distal components of the nervous system, especially in neurological populations(Keser et al., 2022). In contrast to motor-evoked potentials, TEPs also offer the advantage of eliciting cortical responses at TMS intensity below the resting motor threshold.
Measured: Baseline, post 5-week training, and 2-month follow-up
EEG Corticocortical Functional Connectivity
The imaginary part of coherence (iCOH) measured from the source-space EEG time-series will be used as an outcome measure of corticocortical connectivity, representing sensorimotor functional integration.
Measured: Baseline, post 5-week training, and 2-month follow-up
EEG-to-EMG Corticomuscular Connectivity
EG-to-EMG directed transfer function (DTF) will be used as an outcome measure of causal information flow from cortical areas to the leg muscles (Artoni et al., 2017; Peterson and Ferris, 2019). This measure is intended to capture changes in the efferent communication due to combined interventions.
Measured: Baseline, post 5-week training, and 2-month follow-up.
EMG Muscle Coactivation
EMG co-contraction index will be used as an outcome measure of muscle activation between the antagonist and agonist muscle pair involved in reactive balance control.
Measured: Baseline, post 5-week training, and 2-month follow-up.
Diffusion Tensor Imaging (DTI) Fractional Anisotropy
The intervention-related changes in the structural neuroplasticity will be measured using the baseline-to-post-5-week-training changes in the Fractional Anisotropy Laterality Index (FALI) computed from the bilateral corticospinal tracts.
Measured: Baseline and post-5-week training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Aug 2029 (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 Kessler FoundationThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Vikram Shenoy Handiru, Kessler Foundation
- Investigators
- Vikram Shenoy Handiru,, PhD, Principal investigator, Kessler FoundationGuang Yue, PhD, Study director, Kessler FoundationGail Forrest, PhD, Study director, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113041
- Sponsor's protocol ID
- R-1279-24
- Other IDs
- 90REGE0025-01-00
- Acronym
- NEUROBALANCE
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We will submit the IPD available in the tabular data to the ICPSR after removing any personal or private identifiers. The neuroimaging and neurophysiological data (such as the MRI, EEG, TMS, and EMG) will be shared on OpenNeuro.org (or a similar platform) in a BIDS-standardized format.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation-Enhanced Use of RObotic BALANCE Training to Improve Balance Function in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT07113041
- Acronym / sponsor ID
- NEUROBALANCE / R-1279-24
- Conditions
- Stroke, Stroke (CVA) or Transient Ischemic Attack, Stroke Ischemic, Stroke Gait Rehabilitation, Balance Deficits
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 8 Aug 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.
Our proposed study, "NEUROBALANCE Stroke,"; aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance function and postural control in individuals with chronic stroke. The study will recruit 45 participants who have had a stroke at least 6 months before enrolment and experience persistent balance and gait deficits. Participants will be randomized into three groups: (1) robotic balance training with active brain stimulation, (2) robotic balance training with sham brain stimulation, and (3) standard-of-care rehabilitation.
The study will involve 15 training sessions over 5 weeks, with assessments conducted at baseline, post-training, and two months post-training to evaluate balance recovery and retention. The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function. Additionally, participant feedback on brain stimulation and exercise engagement will be collected to inform future studies.
The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RBT + Active HD-tDCS Group | Experimental | Device: Combined (Robotic balance training and high-definition transcranial direct current stimulation)Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using individual MRI-guided neuronavigated transcranial magnetic stimulation (nTMS), and the stimulation will be turned ON for 20 minutes. |
| RBT + Sham HD-tDCS Group | Sham comparator | Device: Combined (Robotic balance training and high-definition transcranial direct current stimulation)Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using individual MRI-guided neuronavigated transcranial magnetic stimulation (nTMS), and the stimulation will be turned ON transiently for 30 s to provide a sensation of stimulation. |
| SOC Control Group | Other | Other: Standard of Care Balance TrainingThe standard of care (SOC) control group participants will perform dose-matched conventional physical therapy exercises delivered by a trained PT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 18-75 years
- Diagnosed with a cortical/subcortical ischemic stroke at least 6 months before the screening, as confirmed by the neurological exam or an MRI.
- Have complaints of impaired balance and poor postural control determined by a BBS score of ≤50.
- Ability to stand upright with or without support for at least 20 seconds
- Ability to walk with or without a walking aid for at least ten meters
Key exclusion criteria (11 listed)
- Currently undergoing any regular physical therapy program or research studies focusing on balance functions.
- Having a brainstem stroke.
- Contraindication for MRI scan (presence of metal implants, claustrophobia)
- Affected by the peripheral nerve injury, neuromuscular conditions, or orthopedic issues of lower limbs before stroke, or have any persistent pain or difficulty maintaining blood pressure while upright.
- Have a scalp or skin condition (e.g., psoriasis or eczema) * on the scalp near the stimulation site
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 |
|---|---|---|
| Combined (Robotic balance training and high-definition transcranial direct current stimulation)The robotic platform will train the participants to maintain dynamic balance in the sagittal and transverse planes (mediolateral and anterior-posterior directions) and engage in core stability and trunk control with seated balance exercises. In addition, high-definition transcranial direct current stimulation (HD-tDCS) will be used as an adjuvant to robotic balance training by priming the corticospinal circuits. | Device | RBT + Active HD-tDCS Group, RBT + Sham HD-tDCS Group |
| Standard of Care Balance TrainingParticipants in this group will receive a standard-of-care balance training (dose matched to the experimental group) administered by the Physical therapist. | Other | SOC Control Group |
Primary outcome
Berg Balance Scale (BBS)
Time frame: Baseline, post 5-week training, 2-month follow-up
A widely used outcome measure of static standing balance function (Newstead et al., 2005), categorized under the 'Activity' subsection of ICF domain. BBS scores range from 0 to 56 (the higher, the better). The change in BBS scores from baseline to 4 weeks post-training will be the primary endpoint.
9 secondary outcomes
Functional Gait Assessment (FGA)
Time frame: Baseline, post 5-week training, and 2-month follow-up
Mini Balance Evaluation Systems Test (MBT)
Time frame: Baseline, post 5-week training, and 2-month follow-up
Trunk Impairment Scale (TIS)
Time frame: Baseline, post 5-week training, and 2-month follow-up
Center of Pressure (COP) Displacement
Time frame: Baseline, post 5-week training, and 2-month follow-up
TMS-evoked EEG Potentials (TEP)
Time frame: Baseline, post 5-week training, and 2-month follow-up
EEG Corticocortical Functional Connectivity
Time frame: Baseline, post 5-week training, and 2-month follow-up
EEG-to-EMG Corticomuscular Connectivity
Time frame: Baseline, post 5-week training, and 2-month follow-up.
EMG Muscle Coactivation
Time frame: Baseline, post 5-week training, and 2-month follow-up.
Diffusion Tensor Imaging (DTI) Fractional Anisotropy
Time frame: Baseline and post-5-week 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 21 Oct 2026.
- Individual participant dataSharing planned: Yes. We will submit the IPD available in the tabular data to the ICPSR after removing any personal or private identifiers. The neuroimaging and neurophysiological data (such as the MRI, EEG, TMS, and EMG) will be shared on OpenNeuro.org (or a similar platform) in a BIDS-standardized format.
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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.
Kathleen Goworek, B.S. contact
Vikram Shenoy Handiru,, PhD principal investigator
Kessler Foundation
Guang Yue, PhD study director
Kessler Foundation
Gail Forrest, PhD study director
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined (Robotic balance training and high-definition transcranial direct current stimulation) in people with Stroke and Stroke (CVA) or Transient Ischemic Attack, run by Kessler Foundation 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 7 inclusion and 11 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 21 Oct 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.
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 Vikram Shenoy Handiru, PhD (9733243578, vshenoy@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS) (time frame: Baseline, post 5-week training, 2-month follow-up). 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 21 Oct 2026.