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Therapeutic effects of focal muscle vibration combined with Tuina on patients with lower-limb spasticity after stroke

A randomized, controlled, monocenter study on therapeutic effects of focal muscle vibration combined with Tuina on patients with lower-limb spasticity after stroke

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034328
Enrollment
Unknown
Registered
2020-07-02
Start date
2022-02-10
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Stroke

Interventions

Tuina group:Tuina intervention
Focal vibration group:Lower-limb vibration
Combined group:Tuina + focal vibration

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate; the subjects have no mental disorders, can fully understand and cooperate with this trial, and are willing to sign the consent form. If the subject is unable to sign due to hemiplegia on the dominant side, the informed consent form may be signed by the subject's legal representative with the subject's agreement; 2. Meet the diagnostic criteria for "Ischemic Stroke (Cerebral Infarction)" or "Cerebral Hemorrhage" in the 2019 published "Key Points in the Diagnosis of Various Cerebrovascular Diseases," and head CT or MRI shows a single unilateral infarct or hemorrhagic lesion; 3. Unilateral hemiplegia, with a MAS score of 1-3 in the plantar flexor muscles on the affected side, and normal muscle tone on the non-affected side; 4. First-ever stroke or previous lacunar infarction with no residual disability; 5. Stroke course between 1 month and 2 years, condition stable, and no progression or deterioration of recent (within 1 month) disease; 6. Age between 18 and 80 years, any gender, any dominant hand; 7. Conscious, basic hearing and comprehension intact, able to cooperate with treatment and assessment; 8. No significant discomfort during postural changes (subject transfers from bed to wheelchair with the help of two people), stable blood pressure, heart rate, and respiration, without pain, chest tightness, shortness of breath, dizziness, headache, etc., able to tolerate 30 minutes in supine or prone position; 9. Able to walk to a certain extent, with or without the aid of a walking device.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of diabetes or other conditions that may cause peripheral nerve damage, Parkinson's disease or other conditions that can lead to high muscle tone, or those with combined muscle disorders; 2. Those with severe cognitive, speech, vision, or hearing impairments (such as deaf-mute individuals) or mental disorders that affect examination and treatment; 3. Patients with concurrent tumors, severe respiratory, heart, liver, kidney, endocrine, or hematopoietic system diseases, such as congestive heart failure, uncontrolled hypertension with blood pressure above 140/90 mmHg, active liver disease, or hepatic and renal dysfunction; 4.Joints being measured that have existing diseases (e.g., severe infection, contracture, joint surgery, rheumatism, or rheumatoid arthritis); 5. Those with contraindications for neuroelectrophysiology, ultrasound assessment, or localized muscle vibration therapy (e.g., skin lesions, fever, history of tumors, pregnancy, breastfeeding, or women of childbearing age not using reliable contraception); 6. Those taking medications affecting muscle tone or who have received botulinum toxin injections in the past three months; 7. Those currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Modified Ashworth Scale;

Secondary

MeasureTime frame
Modified Tardieu Scale;Fugl-Meyer Assessment of the Lower Extremity;Functional Ambulation Categories;Modified Barthel Index;H Reflex;Elastic Modulus;Clonus scale;

Countries

China

Contacts

Public ContactBai Yulong

Huashan Hospital, Fudan University

dr_baiyl@fudan.edu.cn+86 52889999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 27, 2026