Recruiting

Robotic Balance Training & Brain Stimulation

Sponsor:

Kessler Foundation

Code:

NCT07113041

Conditions

Stroke

Stroke (CVA) or Transient Ischemic Attack

Stroke Ischemic

Stroke Gait Rehabilitation

Balance Deficits

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Combined (Robotic balance training and high-definition transcranial direct current stimulation)

Standard of Care Balance Training

Study Details

Brief 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

Study ID

NCT07113041

Start date

Jun 1, 2025

Status verified date

Aug, 2025

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged between 18-75 years
2. Diagnosed with a cortical/subcortical ischemic stroke at least 6 months before the screening, as confirmed by the neurological exam or an MRI.
3. Have complaints of impaired balance and poor postural control determined by a BBS score of ≤50.
4. Ability to stand upright with or without support for at least 20 seconds
5. Ability to walk with or without a walking aid for at least ten meters
6. Not planning to change medication in the next four months
7. 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).

Exclusion Criteria:

1. Currently undergoing any regular physical therapy program or research studies focusing on balance functions.
2. Having a brainstem stroke.
3. Contraindication for MRI scan (presence of metal implants, claustrophobia)
4. 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.
5. Have a scalp or skin condition (e.g., psoriasis or eczema) \* on the scalp near the stimulation site
6. Having severe visual impairment (e.g., spatial neglect) or hearing problems that may affect study compliance
7. Any other neurological injury or psychiatric conditions (e.g., severe anxiety or schizophrenia etc.)
8. Contraindications to MRI, including the presence of non-titanium metallic implants, claustrophobia, etc.
9. Not be pregnant or thinking of becoming pregnant
10. Diagnosed with alcohol or substance abuse in the last 3 years
11. 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.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kathleen Goworek, B.S.

kgoworek@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

More Information

Sponsor

Kessler Foundation

Last update posted

Aug 8, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2025-08-08.