Actively Recruiting
Neuromodulation-Enhanced Use of RObotic BALANCE Training to Improve Balance Function in Individuals With Stroke
Led by Kessler Foundation · Updated on 2025-08-08
45
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
K
Kessler Foundation
Lead Sponsor
N
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Brief Title
Neuromodulation-Enhanced Use of RObotic BALANCE Training to Improve Balance Function in Individuals With Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Kessler Foundation
West Orange, New Jersey, United States, 07052
Actively Recruiting
Research Team
V
Vikram Shenoy Handiru, PhD
K
Kathleen Goworek, B.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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