Neuromodulation-Enhanced Use of RObotic BALANCE Training to Improve Balance Function in Individuals With Stroke (NEUROBALANCE)

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 Overview

• Status: Recruiting
• Conditions: Stroke; Stroke Gait Rehabilitation; Stroke Ischemic; Balance Deficits; Stroke (CVA) or Transient Ischemic Attack
• Intervention / Treatment: Device: Combined (Robotic balance training and high-definition transcranial direct current stimulation); Other: Standard of Care Balance Training

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vikram Shenoy Handiru, PhD; Phone Number: 9733243578; Email: vshenoy@kesslerfoundation.org
• Study Contact Backup: Name: Kathleen Goworek, B.S.; Email: kgoworek@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Kessler Foundation
      • Contact: Vikram Shenoy Handiru, PhD; Phone Number: 9733243578; Email: vshenoy@kesslerfoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged between 18-75 years
2. Diagnosed with a cortical/subcortical ischemic stroke at least 6 months before the screening, as confirmed by the neurological exam or an MRI.
3. Have complaints of impaired balance and poor postural control determined by a BBS score of ≤50.
4. Ability to stand upright with or without support for at least 20 seconds
5. Ability to walk with or without a walking aid for at least ten meters
6. Not planning to change medication in the next four months
7. 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).

Exclusion Criteria:

1. Currently undergoing any regular physical therapy program or research studies focusing on balance functions.
2. Having a brainstem stroke.
3. Contraindication for MRI scan (presence of metal implants, claustrophobia)
4. 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.
5. Have a scalp or skin condition (e.g., psoriasis or eczema) * on the scalp near the stimulation site
6. Having severe visual impairment (e.g., spatial neglect) or hearing problems that may affect study compliance
7. Any other neurological injury or psychiatric conditions (e.g., severe anxiety or schizophrenia etc.)
8. Contraindications to MRI, including the presence of non-titanium metallic implants, claustrophobia, etc.
9. Not be pregnant or thinking of becoming pregnant
10. Diagnosed with alcohol or substance abuse in the last 3 years
11. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RBT + Active HD-tDCS Group; 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); 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.
Sham Comparator: RBT + Sham HD-tDCS Group; 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 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.
Other: SOC Control Group; 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; Participants in this group will receive a standard-of-care balance training (dose matched to the experimental group) administered by the Physical therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, post 5-week training, 2-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.'	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.	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.	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.	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.	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.	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.	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.	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.	Baseline and post-5-week training

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
• Investigators: Study Director: Guang Yue, PhD, Kessler Foundation; Study Director: Gail Forrest, PhD, Kessler Foundation; Principal Investigator: Vikram Shenoy Handiru,, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: August 1, 2025
• First Submitted That Met QC Criteria: August 1, 2025
• First Posted (Actual): August 8, 2025

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Ischemia; Ischemic Stroke; Stroke; Ischemic Attack, Transient; Ischemia
• Other Study ID Numbers: R-1279-24; 90REGE0025-01-00 (Other Grant/Funding Number: National Institute for Disability, Independent Living, and Rehabilitation Research (NIDILRR))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Six months after study completion.
• IPD Sharing Access Criteria: "Authorized Users" (i.e., all Users with an account on the ICSPR) will have access to the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No