TCM Clinical Practice Rehabilitation of Post-stroke Spasticity

Last updated: February 15, 2017
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT03054974
2013BAI10B04
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 (modifiedAshworth scale)

  • Body movement function decreased significantly.

  • The doses and kinds of anticonvulsant drugs should be used stable for more than 1month if they are used

  • Patient must understand and be willing, able and likely to comply with all studyprocedures.

  • Patient must be able to give voluntary written informed consent.

Exclusion

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 syndromeafter acute stroke

  • Accept botulinum toxin or alcohol nerve block 3 months prior to the start of theexperiment

  • 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 Design

Total Participants: 1208
Study Start date:
January 01, 2013
Estimated Completion Date:
December 31, 2018

Study 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.

Connect with a study center

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

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