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NCT Number: NCT07113041

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

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.

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Key information

Conditions

Stroke Balance Deficits Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Ischemic Stroke Nervous System Diseases Stroke (CVA) or Transient Ischemic Attack Stroke Gait Rehabilitation Stroke Ischemic Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location status: Recruiting

Location contact

Vikram Shenoy Handiru, PhD

CONTACT

[email protected]

9733243578

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

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 Training

Other

Participants in this group will receive a standard-of-care balance training (dose matched to the experimental group) administered by the Physical therapist.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Functional Gait Assessment (FGA)

    Time frame: Baseline, post 5-week training, and 2-month follow-up

    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.'

  2. Mini Balance Evaluation Systems Test (MBT)

    Time frame: Baseline, post 5-week training, and 2-month follow-up

    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.

  3. Trunk Impairment Scale (TIS)

    Time frame: Baseline, post 5-week training, and 2-month follow-up

    To estimate the trunk motor impairment(Verheyden et al., 2004). The scale ranges from 0 to 23 and assesses static and dynamic postural control.

  4. Center of Pressure (COP) Displacement

    Time frame: Baseline, post 5-week training, and 2-month follow-up

    To evaluate the body sway in response to the perturbations of the posturography platform.

  5. TMS-evoked EEG Potentials (TEP)

    Time frame: Baseline, post 5-week training, and 2-month follow-up

    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.

  6. EEG Corticocortical Functional Connectivity

    Time frame: Baseline, post 5-week training, and 2-month follow-up

    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.

  7. EEG-to-EMG Corticomuscular Connectivity

    Time frame: Baseline, post 5-week training, and 2-month follow-up.

    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.

  8. EMG Muscle Coactivation

    Time frame: Baseline, post 5-week training, and 2-month follow-up.

    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.

  9. Diffusion Tensor Imaging (DTI) Fractional Anisotropy

    Time frame: Baseline and post-5-week training

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen Goworek, B.S.

CONTACT

[email protected]

Vikram Shenoy Handiru, PhD

CONTACT

[email protected]

9733243578

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Acronym: NEUROBALANCE

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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