TCM Clinical Practice Rehabilitation of Post-stroke Spasticity

February 15, 2017 updated by: JiangFeng, The First Affiliated Hospital with Nanjing Medical University

Traditional Chinese Medicine Clinical Practice Rehabilitation of Post-stroke Spasticity

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
        • Principal Investigator:
          • Li jianan, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modern rehabilitation treatment
Other: Modern rehabilitation treatment
PT 1 hour per day and OT 30min per day
Experimental: Modern rehabilitation &TCM
Modern rehabilitation treatment and traditional Chinese medicine
Other: Modern rehabilitation &TCM
Traditional Chinese Medicine, including massage and medicated bath
Experimental: modern rehabilitation &Baimai Ruangao
modern rehabilitation treatment and Baimai Ruangao
Other: modern rehabilitation &Baimai Ruangao
modern rehabilitation treatment with Baimai Ruangao and massage
Experimental: modern rehabilitation &Tibetan medicine
modern rehabilitation treatment and Tibetan medicine treatment
Other: modern rehabilitation &Tibetan medicine
modern rehabilitation treatment and Tibetan medicine(medicated bath with wuweiganlu and rub with baimairuangao)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale
Time Frame: 6 months
the common used clinical measurement to assess the levels of limb spasticity
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Fugl-Meyer Moter Assessment
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Barthel Index
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Chair: Li jianan, Doctor, The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 20, 2016

First Submitted That Met QC Criteria

February 15, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 15, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013BAI10B04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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