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Search / Trial NCT07113041

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

Launched by KESSLER FOUNDATION · Aug 1, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people who have had a stroke improve their balance and walking. The study combines special robotic balance training with gentle, noninvasive brain stimulation to see if this approach can help people regain better control of their posture and movement. The goal is to find out if this combined treatment works better than standard rehabilitation or robotic training alone. Researchers will also look at how these treatments affect brain and muscle activity during balance tasks.

People who might join this study are adults between 18 and 75 years old who had a stroke at least six months ago and still have trouble with balance or walking. Participants need to be able to stand for at least 20 seconds and walk at least 10 meters, with or without help. The study will last about five weeks, with 15 training sessions, and participants will be checked before, right after, and two months after the training to see how much they’ve improved. This study could help develop better, personalized rehabilitation programs for stroke survivors in the future.

Gender

ALL

Eligibility criteria

  • 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.

About Kessler Foundation

Kessler Foundation is a leading nonprofit organization dedicated to advanced rehabilitation research and the development of innovative strategies to improve the lives of individuals with disabilities. With a strong emphasis on clinical trials and evidence-based practices, the Foundation collaborates with academic institutions, healthcare providers, and industry partners to explore novel therapeutic approaches and technologies. Its commitment to enhancing mobility, cognitive function, and overall quality of life for people with neurological and musculoskeletal conditions drives its mission to transform rehabilitation outcomes through cutting-edge research and community engagement.

Locations

West Orange, New Jersey, United States

Patients applied

0 patients applied

Trial Officials

Vikram Shenoy Handiru,, PhD

Principal Investigator

Kessler Foundation

Guang Yue, PhD

Study Director

Kessler Foundation

Gail Forrest, PhD

Study Director

Kessler Foundation

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported