No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Kessler Foundation · Other
Who this trial is looking for
This trial is looking for adults aged 18-75 who have had a stroke and struggle with balance. Participants will take part in robotic training sessions for five weeks to improve their balance and control.
Are You a Good Fit for This Trial?
Rules you outSubstance abuse
You may be able to join if
I am aged between 18-75 years
I had a stroke at least 6 months ago
I have balance problems as shown by my score on a balance test
I can stand upright for at least 20 seconds
I can walk at least ten meters with or without a walking aid
I am not planning to change my medication in the next four months
I can understand and follow verbal instructions
You may not be able to join if
I am currently in a physical therapy program
I have had a brainstem stroke
I have metal implants that prohibit an MRI scan
I have nerve injuries or pain that affects my lower limbs
I have a scalp condition near the stimulation site
I have severe vision or hearing problems that affect my ability to participate
I have other neurological or psychiatric conditions
I am pregnant or planning to become pregnant
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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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. Abi…
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.
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