Neuromodulation-Enhanced Use of RObotic BALANCE Training to Improve Balance Function in Individuals With Stroke
NCT ID: NCT07113041
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2025-06-01
2029-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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.
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.
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.
SOC Control Group
The standard of care (SOC) control group participants will perform dose-matched conventional physical therapy exercises delivered by a trained PT.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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National Institute on Disability, Independent Living, and Rehabilitation Research
FED
Kessler Foundation
OTHER
Responsible Party
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Vikram Shenoy Handiru
Research Scientist
Principal Investigators
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Vikram Shenoy Handiru,, PhD
Role: PRINCIPAL_INVESTIGATOR
Kessler Foundation
Guang Yue, PhD
Role: STUDY_DIRECTOR
Kessler Foundation
Gail Forrest, PhD
Role: STUDY_DIRECTOR
Kessler Foundation
Locations
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Kessler Foundation
West Orange, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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90REGE0025-01-00
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
R-1279-24
Identifier Type: -
Identifier Source: org_study_id
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