TCM Clinical Practice Rehabilitation of Post-stroke Spasticity

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

Tracking Information

• First Submitted Date: November 20, 2016
• First Posted Date: February 16, 2017
• Last Update Posted Date: February 16, 2017
• Study Start Date: January 2013
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: February 15, 2017): Fugl-Meyer Moter Assessment [ Time Frame: 6 months ]
• Original Secondary Outcome Measures: 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: TCM Clinical Practice Rehabilitation of Post-stroke Spasticity
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stroke

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 15, 2017): 1208
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2018
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03054974
• Other Study ID Numbers: 2013BAI10B04
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: JiangFeng, The First Affiliated Hospital with Nanjing Medical University
• Study Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Not Provided

Investigators

• 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