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The therapeutic effects of focal vibration combined with rTMS on poststroke spasticity of lower limbs and "central-peripheral" modulation

The therapeutic effects of focal vibration combined with rTMS on poststroke spasticity of lower limbs and "central-peripheral" modulation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078374
Enrollment
Unknown
Registered
2023-12-06
Start date
2023-12-21
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Stroke

Interventions

FMV group:FMV+physical therapy
FMV+rTMS (single cortex):FMV+rTMS (single cortex)+physical therapy
FMV+rTMS (paired cortices):FMV+rTMS (paired cortices)+physical therapy

Sponsors

Shanghai Geriatric Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) It meets the diagnosis of "stroke" in the "Diagnostic Points of Various Cerebrovascular Diseases" adopted by the Fourth National Cerebrovascular Disease Conference in 2019, and the head CT or MRI examination showed a single infarction or hemorrhage. (2) Aged 18-80 years. (3) Subject had a stroke course of 3 month to 1 year. (4) Hemiplegia, hemiplegic lateral ankle and plantar flexor muscle group modified Ashworth scale score from 1+ to 3. (5) Subjects voluntary to participate, understanding the orders, and signing the informed consent forms. (6) The condition was stable, and the disease did not progress or deteriorate in the recent period.

Exclusion criteria

Exclusion criteria: (1) Hypertonia caused by PD; the joints have severe infection, contracture, operations, rheumatoid arthritis, ect. (2) Severe cognitive, language, visual, auditory dysfunction or mental disorders. (3) Tumor; severe inspiratory, cardiovascular disease. (4) There are contraindications for neuroelectrophysiology, sEMG, local muscle vibration therapy and MRI. (5) Use botulinum toxin injection in the last 3 months; ;the dosage of anti-spasm drugs is changed within a month.

Design outcomes

Primary

MeasureTime frame
Modified Ashworth Scale;

Secondary

MeasureTime frame
Clonus Scale;Fugl-Meyer Assessment;10m walking test;sEMG and gait analyses;neuroelectrical parameters;fMRI;

Countries

China

Contacts

Public ContactYinglun Chen

Shanghai Geriatric Medical Center

chenyl11@foxmail.com+86 51371990

Outcome results

None listed

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