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
221 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
Official 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 and 75 years
- Diagnosed with cortical or subcortical ischemic stroke at least 6 months before screening confirmed by neurological exam or MRI
- Complaints of impaired balance and poor postural control with a Berg Balance Scale score of 50 or less
- Able to stand upright with or without support for at least 20 seconds
- Able to walk at least 10 meters with or without a walking aid
- Not planning to change medications in the next four months
- Sufficient cognitive ability to understand instructions and follow study procedures as assessed by the UBACC
You will not qualify if you...
- Currently receiving regular physical therapy or participating in research focused on balance
- Having a brainstem stroke
- Contraindications for MRI such as metal implants or claustrophobia
- Peripheral nerve injury, neuromuscular conditions, orthopedic issues of lower limbs before stroke, or persistent pain or blood pressure difficulties when upright
- Scalp or skin conditions near the stimulation site like psoriasis or eczema
- Severe visual impairments or hearing problems affecting study participation
- Other neurological or psychiatric conditions such as severe anxiety or schizophrenia
- Presence of non-titanium metallic implants or other MRI contraindications
- Pregnant or planning to become pregnant
- Diagnosed with alcohol or substance abuse in the last three years
- Contraindications to transcranial magnetic stimulation including metallic implants in the head, history of seizures, medication-resistant epilepsy, or use of 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
CONTACT
K
Kathleen Goworek, B.S.
CONTACT
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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