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TCM Clinical Practice Rehabilitation of Post-stroke Spasticity

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ClinicalTrials.gov Identifier: NCT03054974
Recruitment Status : Unknown
Verified February 2017 by JiangFeng, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
JiangFeng, The First Affiliated Hospital with Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE November 20, 2016
First Posted Date  ICMJE February 16, 2017
Last Update Posted Date February 16, 2017
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
Modified Ashworth Scale [ Time Frame: 6 months ]
the common used clinical measurement to assess the levels of limb spasticity
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
Fugl-Meyer Moter Assessment [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 15, 2017)
Barthel Index [ Time Frame: 6 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE TCM Clinical Practice Rehabilitation of Post-stroke Spasticity
Official Title  ICMJE Traditional Chinese Medicine Clinical Practice Rehabilitation of Post-stroke Spasticity
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Other: Modern rehabilitation treatment
    PT 1 hour per day and OT 30min per day
  • Other: Modern rehabilitation &TCM
    Traditional Chinese Medicine, including massage and medicated bath
  • Other: modern rehabilitation &Baimai Ruangao
    modern rehabilitation treatment with Baimai Ruangao and massage
  • Other: modern rehabilitation &Tibetan medicine
    modern rehabilitation treatment and Tibetan medicine(medicated bath with wuweiganlu and rub with baimairuangao)
Study Arms  ICMJE
  • Experimental: Modern rehabilitation treatment
    Modern rehabilitation treatment
    Intervention: Other: Modern rehabilitation treatment
  • Experimental: Modern rehabilitation &TCM
    Modern rehabilitation treatment and traditional Chinese medicine
    Intervention: Other: Modern rehabilitation &TCM
  • Experimental: modern rehabilitation &Baimai Ruangao
    modern rehabilitation treatment and Baimai Ruangao
    Intervention: Other: modern rehabilitation &Baimai Ruangao
  • Experimental: modern rehabilitation &Tibetan medicine
    modern rehabilitation treatment and Tibetan medicine treatment
    Intervention: Other: modern rehabilitation &Tibetan medicine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 15, 2017)
1208
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03054974
Other Study ID Numbers  ICMJE 2013BAI10B04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party JiangFeng, The First Affiliated Hospital with Nanjing Medical University
Study Sponsor  ICMJE The First Affiliated Hospital with Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Li jianan, Doctor The First Affiliated Hospital with Nanjing Medical University
PRS Account The First Affiliated Hospital with Nanjing Medical University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP