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

Kessler Foundation

Status: Enrolling

Conditions: Stroke; Balance Deficits; Stroke Ischemic; Stroke (CVA) or Transient Ischemic Attack; Stroke Gait Rehabilitation

Treatments: Device: Combined (Robotic balance training and high-definition transcranial direct current stimulation); Other: Standard of Care Balance Training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07113041

R-1279-24

90REGE0025-01-00 (Other Grant/Funding Number)

Details and patient eligibility

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

RBT + Active HD-tDCS Group

Experimental group

Description:

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.

Treatment:

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

RBT + Sham HD-tDCS Group

Sham Comparator group

Description:

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.

Treatment:

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

SOC Control Group

Other group

Description:

The standard of care (SOC) control group participants will perform dose-matched conventional physical therapy exercises delivered by a trained PT.

Treatment:

Other: Standard of Care Balance Training