TCM Clinical Practice Rehabilitation of Post-stroke Spasticity

NCT ID: NCT03054974

Last Updated: 2017-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Modern rehabilitation treatment

Modern rehabilitation treatment

Group Type EXPERIMENTAL

Modern rehabilitation treatment

Intervention Type OTHER

PT 1 hour per day and OT 30min per day

Modern rehabilitation &TCM

Modern rehabilitation treatment and traditional Chinese medicine

Group Type EXPERIMENTAL

Modern rehabilitation &TCM

Intervention Type OTHER

Traditional Chinese Medicine, including massage and medicated bath

modern rehabilitation &Baimai Ruangao

modern rehabilitation treatment and Baimai Ruangao

Group Type EXPERIMENTAL

modern rehabilitation &Baimai Ruangao

Intervention Type OTHER

modern rehabilitation treatment with Baimai Ruangao and massage

modern rehabilitation &Tibetan medicine

modern rehabilitation treatment and Tibetan medicine treatment

Group Type EXPERIMENTAL

modern rehabilitation &Tibetan medicine

Intervention Type OTHER

modern rehabilitation treatment and Tibetan medicine(medicated bath with wuweiganlu and rub with baimairuangao)

Interventions

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Modern rehabilitation treatment

PT 1 hour per day and OT 30min per day

Intervention Type OTHER

Modern rehabilitation &TCM

Traditional Chinese Medicine, including massage and medicated bath

Intervention Type OTHER

modern rehabilitation &Baimai Ruangao

modern rehabilitation treatment with Baimai Ruangao and massage

Intervention Type OTHER

modern rehabilitation &Tibetan medicine

modern rehabilitation treatment and Tibetan medicine(medicated bath with wuweiganlu and rub with baimairuangao)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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JiangFeng

JiangFeng Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li jianan, Doctor

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Locations

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Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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li jianan, Doctor

Role: CONTACT

+862583318752

Facility Contacts

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Li jianan, Doctor

Role: primary

+862583318752

Other Identifiers

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2013BAI10B04

Identifier Type: -

Identifier Source: org_study_id

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