NCT07113041

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Stroke (CVA) or Transient Ischemic Attack
• Stroke Ischemic
• Stroke Gait Rehabilitation
• Balance Deficits

Interventions

Type	Name	Description
DEVICE	Combined (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.
OTHER	Standard of Care Balance Training	Participants in this group will receive a standard-of-care balance training (dose matched to the experimental group) administered by the Physical therapist.

Timeline

• Start date: 2025-06-01
• Primary completion: 2028-12-31
• Completion: 2029-08-31
• First posted: 2025-08-08
• Last updated: 2025-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study