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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Combined (Robotic balance training and high-definition transcranial direct current stimulation) — DEVICE
  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.
• Standard of Care Balance Training — OTHER
  Participants in this group will receive a standard-of-care balance training (dose matched to the experimental group) administered by the Physical therapist.

Study Details

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.

Key Dates

Start date

Jun 1, 2025

Status verified

Aug 2025

Primary completion

Dec 31, 2028

Completion

Aug 31, 2029

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Berg Balance Scale (BBS) [ Time Frame: Baseline, post 5-week training, 2-month follow-up ]

Central Contacts

• Vikram Shenoy Handiru, PhD
  9733243578
  [email protected]
• Kathleen Goworek, B.S.
  [email protected]

Locations (1)

Find similar trials in West Orange, NJ

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