NCT01003470

Brief Summary

The purpose of this study is to evaluate the therapeutic effect of acupuncture method of "Xing Nao Kai Qiao" for paralysis as an apoplectic sequela in a multicenter randomized and controlled clinical trial and to compare the efficacy between acupuncture and rehabilitation therapy. In addition, evaluating the trial in the view of medical economics.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
288

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 28, 2009

Status Verified

October 1, 2009

Enrollment Period

3 years

First QC Date

October 27, 2009

Last Update Submit

October 27, 2009

Conditions

Cerebral Infarction

Keywords

cerebral infarctionParalysisacupuncturerehabilitationtrial

Outcome Measures

Primary Outcomes (1)

  • Score of neurological defect

    before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.

Secondary Outcomes (3)

  • Visualized anologue score

    before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.

  • Spasm evaluation

    before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.

  • Safety evaluation

    before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.

Study Arms (3)

acupuncture

EXPERIMENTAL
Other: acupuncture

rehabilitation

ACTIVE COMPARATOR
Behavioral: rehabilitation

acupuncture and rehabilitation

ACTIVE COMPARATOR
Other: acupuncture and rehabilitation

Interventions

acupunctureOTHER

Xing Nao Kai Qiao Acupuncture

acupuncture
rehabilitationBEHAVIORAL

Kinesitherapy

rehabilitation
acupuncture and rehabilitationOTHER

Xing Nao Kai Qiao Acupuncture plus Kinesitherapy

acupuncture and rehabilitation

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cerebral infarction diagnosed according to the diagnostic standard of western medicine
  • Apoplexy diagnosed according to the diagnostic standard of traditional Chinese medicine for apoplexy
  • Cerebral vascular accident occured in the internal carotid artery system which was verified by cerebral CT or MRI
  • The incidence of apoplexy less than twice and the time of onset 15\~3 months
  • Age: 40-75 years, non-limited gender
  • NDS score of limb functional defect ≥10
  • The patient was alert and the vital signs are stable
  • Participant signed the informed consent form

You may not qualify if:

  • TIA or RIND
  • The nerve function defect induced by the cerebral tumor, trauma, parasitic diseases, heart disease and metabolic disorder or hemorrhagic cerebrovascular disease
  • Pregnant or breast-feeding women
  • Complicated with severe primary disease in heart, liver, kidney and hematology system or psychopath

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM)

Tianjin, Tianjin Municipality, 300193, China

RECRUITING

Related Publications (1)

  • Shiflett SC. Does acupuncture work for stroke rehabilitation: what do recent clinical trials really show? Top Stroke Rehabil. 2007 Jul-Aug;14(4):40-58. doi: 10.1310/tsr1404-40.

    PMID: 17698457BACKGROUND

Related Links

MeSH Terms

Conditions

Cerebral InfarctionParalysis

Interventions

Acupuncture TherapyRehabilitation

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sicheng Wang, Master

    State Administration of Traditional Chinese Medicine of China

    STUDY DIRECTOR

Central Study Contacts

Lixin Fu, M.D.

CONTACT

86-13821316617fulixin66@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 28, 2009

Study Start

October 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2010

Last Updated

October 28, 2009

Record last verified: 2009-10

Locations

CN(1)