Robotic balance training with brain stimulation to improve balance after stroke
Neuromodulation-Enhanced Use of RObotic BALANCE Training to Improve Balance Function in Individuals With Stroke
This program tests whether adding noninvasive brain stimulation to robotic balance training helps people with chronic stroke who still have balance and walking problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT07113041 on ClinicalTrials.gov |
What this trial studies
NEUROBALANCE Stroke will randomize 45 people with chronic ischemic stroke into three groups: robotic balance training with active high-definition transcranial direct current stimulation (HD-tDCS), robotic balance training with sham stimulation, or standard-of-care balance rehabilitation. Participants will complete 15 training sessions over five weeks with assessments at baseline, immediately after training, and two months later to measure retention. Outcomes include clinical balance measures, gait tests, and recordings of brain and muscle activity during balance tasks to link neural changes with functional gains. The goal is to determine whether the combined neuromodulation and robotic approach produces greater and more durable balance improvements than standard care.
Who should consider this trial
Good fit: Ideal candidates are people aged 18–75 with a cortical or subcortical ischemic stroke at least six months earlier who have persistent balance problems (Berg Balance Scale ≤50) and can stand for at least 20 seconds and walk 10 meters with or without assistance.
Not a fit: People with brainstem strokes, those who cannot undergo MRI, those already in regular balance-focused physical therapy or competing research, or those who cannot meet the standing/walking requirements are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the combined robotic and brain-stimulation approach could produce larger and longer-lasting improvements in balance and walking ability than standard rehabilitation alone.
How similar studies have performed: Prior small trials combining noninvasive brain stimulation with rehabilitation after stroke have shown mixed but sometimes promising results, while larger definitive trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Vikram Shenoy Handiru,, PhD — Kessler Foundation
- Study coordinator: Vikram Shenoy Handiru, PhD
- Email: vshenoy@kesslerfoundation.org
- Phone: 9733243578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.