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TCM Clinical Practice Rehabilitation of Post-stroke Spasticity

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Modern rehabilitation treatment
Modern rehabilitation &TCM
modern rehabilitation &Baimai Ruangao
modern rehabilitation &Tibetan medicine
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Traditional Chinese Medicine, Rehabilitation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Jiangsu Province HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Modern rehabilitation treatment

Modern rehabilitation &TCM

modern rehabilitation &Baimai Ruangao

modern rehabilitation &Tibetan medicine

Arm Description

Modern rehabilitation treatment

Modern rehabilitation treatment and traditional Chinese medicine

modern rehabilitation treatment and Baimai Ruangao

modern rehabilitation treatment and Tibetan medicine treatment

Outcomes

Primary Outcome Measures

Modified Ashworth Scale
the common used clinical measurement to assess the levels of limb spasticity

Secondary Outcome Measures

Fugl-Meyer Moter Assessment

Full Information

First Posted
November 20, 2016
Last Updated
February 15, 2017
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03054974
Brief Title
TCM Clinical Practice Rehabilitation of Post-stroke Spasticity
Official Title
Traditional Chinese Medicine Clinical Practice Rehabilitation of Post-stroke Spasticity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Traditional Chinese Medicine, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modern rehabilitation treatment
Arm Type
Experimental
Arm Description
Modern rehabilitation treatment
Arm Title
Modern rehabilitation &TCM
Arm Type
Experimental
Arm Description
Modern rehabilitation treatment and traditional Chinese medicine
Arm Title
modern rehabilitation &Baimai Ruangao
Arm Type
Experimental
Arm Description
modern rehabilitation treatment and Baimai Ruangao
Arm Title
modern rehabilitation &Tibetan medicine
Arm Type
Experimental
Arm Description
modern rehabilitation treatment and Tibetan medicine treatment
Intervention Type
Other
Intervention Name(s)
Modern rehabilitation treatment
Intervention Description
PT 1 hour per day and OT 30min per day
Intervention Type
Other
Intervention Name(s)
Modern rehabilitation &TCM
Intervention Description
Traditional Chinese Medicine, including massage and medicated bath
Intervention Type
Other
Intervention Name(s)
modern rehabilitation &Baimai Ruangao
Intervention Description
modern rehabilitation treatment with Baimai Ruangao and massage
Intervention Type
Other
Intervention Name(s)
modern rehabilitation &Tibetan medicine
Intervention Description
modern rehabilitation treatment and Tibetan medicine(medicated bath with wuweiganlu and rub with baimairuangao)
Primary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
the common used clinical measurement to assess the levels of limb spasticity
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fugl-Meyer Moter Assessment
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Barthel Index
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
li jianan, Doctor
Phone
+862583318752
Email
lijianan@carm.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li jianan, Doctor
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li jianan, Doctor
Phone
+862583318752
Email
lijianan@carm.org.cn
First Name & Middle Initial & Last Name & Degree
Li jianan, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No

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TCM Clinical Practice Rehabilitation of Post-stroke Spasticity

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