Balance Deficits, Stroke, Stroke (CVA) or Transient Ischemic Attack, Stroke Gait Rehabilitation, Stroke Ischemic
Conditions
Brief 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. 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.
Interventions
DEVICECombined (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.
Participants in this group will receive a standard-of-care balance training (dose matched to the experimental group) administered by the Physical therapist.
Sponsors
National Institute on Disability, Independent Living, and Rehabilitation Research
Kessler Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The mode of HD-tDCS (active/sham) will be masked for the participant, the study investigator, and the outcomes assessor.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale (BBS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Mini Balance Evaluation Systems Test (MBT) | 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. |
| Trunk Impairment Scale (TIS) | 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. |
| Center of Pressure (COP) Displacement | Baseline, post 5-week training, and 2-month follow-up | To evaluate the body sway in response to the perturbations of the posturography platform. |
| TMS-evoked EEG Potentials (TEP) | 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. |
| Functional Gait Assessment (FGA) | 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.' |
| EEG-to-EMG Corticomuscular Connectivity | 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. |
| EMG Muscle Coactivation | 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. |
| Diffusion Tensor Imaging (DTI) Fractional Anisotropy | 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. |
| EEG Corticocortical Functional Connectivity | 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. |
Countries
United States
Contacts
Primary ContactVikram Shenoy Handiru, PhD
Backup ContactKathleen Goworek, B.S.
Outcome results
None listed