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| ID | Type | Description | Link |
|---|---|---|---|
| 90REGE0025-01-00 | Other Grant/Funding Number | National Institute for Disability, Independent Living, and Rehabilitation Research (NIDILRR) |
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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vikram Shenoy Handiru, PhD | Contact | 9733243578 | vshenoy@kesslerfoundation.org | |
| Kathleen Goworek, B.S. | Contact | kgoworek@kesslerfoundation.org |
| Name | Affiliation | Role |
|---|---|---|
| Vikram Shenoy Handiru,, PhD | Kessler Foundation | Principal Investigator |
| Guang Yue, PhD | Kessler Foundation | Study Director |
| Gail Forrest, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | Recruiting | West Orange | New Jersey | 07052 | United States |
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.
Six months after study completion.
"Authorized Users" (i.e., all Users with an account on the ICSPR) will have access to the data.
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The mode of HD-tDCS (active/sham) will be masked for the participant, the study investigator, and the outcomes assessor.
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| 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. |
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| 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 |
| Kessler Foundation |
| Study Director |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
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