Skip to content

Bilateral rTMS Combined with Balance Training for Post-stroke Gait Recovery: A Protocol for a Prospective Study

Bilateral rTMS Combined with Balance Training for Post-stroke Gait Recovery: A Protocol for a Prospective Study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102071
Enrollment
Unknown
Registered
2025-05-08
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

Bilateral rTMS Combined with Balance Training Group:The bilateral stimulation protocol comprises high-frequency stimulation (10 Hz) to the affected hemisphere at 90% RMT, delivered in 40 trains of 50
Unilateral rTMS combined with balance training group:The control group will receive unilateral rTMS using identical equipment and setup procedures, with high-frequency stimulation to the affected hemi

Sponsors

Guangdong Sanjiu Brain Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) age 18-75 years; (2) first-ever ischemic stroke confirmed by CT or MRI occurring between 2-8 weeks before enrollment, consistent with the therapeutic window identified in recent meta-analyses (Chen et al., 2023); (3) unilateral supratentorial lesion affecting motor function; (4) Brunnstrom stage III-V for lower extremity, allowing sufficient motor function for balance training participation while maintaining rehabilitation potential (Wang et al., 2024); (5) ability to maintain standing position for at least 1 minute with minimal support; (6) Functional Ambulation Category (FAC) score 2-4, indicating potential for gait improvement; (7) Mini-Mental State Examination (MMSE) score >= 24, ensuring adequate cognitive function for informed participation and following instructions; and (8) written informed consent.

Exclusion criteria

Exclusion criteria: (1) contraindications to rTMS according to current safety guidelines[17], including history of epilepsy, metal implants in the head region, or cardiac pacemakers; (2) severe cognitive impairment, aphasia, or psychiatric disorders that might interfere with assessment or treatment compliance; (3) other neurological conditions affecting motor function (e.g., Parkinson's disease, multiple sclerosis); (4) severe cardiovascular or respiratory diseases limiting participation in balance training; (5) uncontrolled hypertension (>180/100 mmHg); (6) previous brain surgery or severe brain trauma; (7) current participation in other clinical trials; (8) severe spasticity (Modified Ashworth Scale >3) that might interfere with gait assessment; (9) severe visual or vestibular disorders affecting balance; and (10) previous exposure to rTMS therapy within the past three months.

Design outcomes

Primary

MeasureTime frame
The Functional Ambulation Category;Gait parameters ;Fugl-Meyer Assessment Lower Extremity subscale;Berg Balance Scale;Modified Barthel Index (MBI);

Countries

China

Contacts

Public ContactYongliang Guo

Guangdong Sanjiu Brain Hospital

drguoyl@126.com+86 137 2514 2578

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026