Clinical trial NCT03054974: TCM Clinical Practice Rehabilitation of Post-stroke Spasticity
Official title: Traditional Chinese Medicine Clinical Practice Rehabilitation of Post-stroke Spasticity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Traditional Chinese Medicine
Rehabilitation
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 1208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: 6 months
Secondary outcomes:
measure: Fugl-Meyer Moter Assessment
timeFrame: 6 months
Other outcomes:
measure: Barthel Index
timeFrame: 6 months
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Li jianan, Doctor
role: STUDY_CHAIR
References: