An interventional study of Combined (Robotic balance training and high-definition transcranial direct current stimulation) and Standard of Care Balance Training in Stroke, Stroke (CVA) or Transient Ischemic Attack and Stroke Ischemic, sponsored by Kessler Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 45 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Kessler Foundation is the lead sponsor of 175 studies on the registry; 61 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Ischemic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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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.
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.
Device: Combined (Robotic balance training and high-definition transcranial direct current stimulation)
The standard of care (SOC) control group participants will perform dose-matched conventional physical therapy exercises delivered by a trained PT.
Other: Standard of Care Balance Training
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.
Participants in this group will receive a standard-of-care balance training (dose matched to the experimental group) administered by the Physical therapist.
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.
Time frame: Baseline, post 5-week training, 2-month follow-up
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.'
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and post-5-week training
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Six months after study completion.
Access criteria: "Authorized Users" (i.e., all Users with an account on the ICSPR) will have access to the data.
Data sharing details ↗ · www.icpsr.umich.edu
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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