Neuromodulation-Enhanced Use of RObotic BALANCE Training to Improve Balance Function in Individuals With Stroke

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
United States
New Jersey
Kessler Foundation
RECRUITING
West Orange
Contact Information
Primary
Vikram Shenoy Handiru, PhD
vshenoy@kesslerfoundation.org
9733243578
Backup
Kathleen Goworek, B.S.
kgoworek@kesslerfoundation.org
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 45
Treatments
Experimental: RBT + Active HD-tDCS Group
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.
Sham_comparator: RBT + Sham HD-tDCS Group
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.
Other: SOC Control Group
The standard of care (SOC) control group participants will perform dose-matched conventional physical therapy exercises delivered by a trained PT.
Related Therapeutic Areas
Sponsors
Leads: Kessler Foundation
Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research

This content was sourced from clinicaltrials.gov

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