TCM Clinical Practice Rehabilitation of Post-stroke Spasticity

Nanjing Medical University

Status: Unknown

Conditions: Stroke

Treatments: Other: modern rehabilitation &Baimai Ruangao; Other: modern rehabilitation &Tibetan medicine; Other: Modern rehabilitation treatment; Other: Modern rehabilitation &TCM

Study type: Interventional

Funder types: Other

Identifiers

NCT03054974

2013BAI10B04

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness,safety and Input-output ratio of chinese traditional treatment in spasm after stroke,both in massage and herbal medicine bathing.

Full description

A Muti-center randomized controlled study with large samples to observe improvement of motor function,severity of spasm,ADL(activity of daily lives),by standardized protocols of TCM techniques(massage and herbal bathing) combined with conventional rehabilitation on spasm after stroke in 1 month.Modified Ashworth scale,Fugl-Meyer Index and Modified barthel Index were used for spasm,motor function and ADL.And also the follow up research within 3 months and 6 months focus on the efficacy duration of TCM on spasm.Try to find suitable timing for intervention on spasm by CTM(Massage and herbal medicine bathing)and the connection between spasm severity and treatment efficacy.

Enrollment: 1,208 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• According to the diagnostic criteria of stroke and diagnosed by CT or MRI
• Patient must be between the ages of 18 and 85 years.
• All patients were examined at least 1 month after stroke and less than 12 months.
• At least a set of spasmous muscles' level ≥1+ of dysfunctional extremities (modified Ashworth scale)
• Body movement function decreased significantly.
• The doses and kinds of anticonvulsant drugs should be used stable for more than 1 month if they are used
• Patient must understand and be willing, able and likely to comply with all study procedures.
• Patient must be able to give voluntary written informed consent.

Exclusion criteria

• Significant cognitive defects(MMSE<16)，unable to finish the Fugl-Meyer scale,etc..
• Other significant limb diseases such as fracture, severe arthritis,amputation
• Joint contracture formation
• Patients with significant pain and swelling suffering from complex regional syndrome after acute stroke
• Accept botulinum toxin or alcohol nerve block 3 months prior to the start of the experiment
• Patients need nerve block at any point of time during the whole experiment procedure.
• Serious cardiac,hepatic or renal insufficiency and patients with shock.
• Limb skin of patients who need medicated is visible wound.
• Patients with cancer or pregnancy
• Patients who participate in other clinical studies within 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,208 participants in 4 patient groups

Modern rehabilitation treatment

Experimental group

Description:

Modern rehabilitation treatment

Treatment:

Other: Modern rehabilitation treatment

Modern rehabilitation &TCM

Experimental group

Description:

Modern rehabilitation treatment and traditional Chinese medicine

Treatment:

Other: Modern rehabilitation &TCM

modern rehabilitation &Baimai Ruangao

Experimental group

Description:

modern rehabilitation treatment and Baimai Ruangao

Treatment:

Other: modern rehabilitation &Baimai Ruangao

modern rehabilitation &Tibetan medicine

Experimental group

Description:

modern rehabilitation treatment and Tibetan medicine treatment

Treatment:

Other: modern rehabilitation &Tibetan medicine