Clinical trial NCT02210988: Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients
Official title: Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Keywords: Acupuncture therap
Acute stroke
Randomized controlled trials
Lead sponsor: Cathay General Hospital
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators design a randomized, single blinded, control study to evaluate the therapeutic effect of acupuncture in acute ischemic stroke patients:

Detailed description: Acupuncture therapy in traditional Chinese medicine has been verified in many disease by thousands years. Due to the feasible and relatively safe in acupuncture management, now the west countries had been well document about acupuncture in medicine. The acupuncture therapy applied in post stroke functional recovery has been considered as more benefit than physical therapy only to post stroke rehabilitation. However, the effect of combined acupuncture therapy with standard management in acute stroke patient still remains unknown. The aim of this study is to evaluate the therapeutic effect of acupuncture in acute ischemic stroke patients. The prospective study was designed as a randomized, single blinded, control trial. We collected newly onset of acute ischemic stroke patient without underling systemic major illness, and randomized assign the collected patients into two groups as experimental (acupuncture)group and normal control group. The two groups both treat with routine western medicine as standard stroke therapy. The outcome measurement will evaluate by the changes from baseline at one and three months. The assessed scales including NIH stroke scale, the Barthel index, the Functional Independence Measure score, the Fugl-Meyer Assessment, and the Modified Rankin Scale. We compared the all variable measurements to see if any benefit from acupuncture group than the control group.

Eligibility criteria: Inclusion Criteria:

* newly onset of acute ischemic stroke,Exclusion Criteria:
* without underling systemic major illness

Primary outcomes:
measure: National Institute of Health Stroke Scale
timeFrame: the fourth week
measure: Fugal-Mayer Assessment
timeFrame: The fourth week
measure: Functional Independent Measure
timeFrame: The fourth week
Secondary outcomes:
measure: National Institute of Health Stroke Scale
timeFrame: The three months after admission
measure: Barthel index
timeFrame: The three month after admission
measure: Modified Rankin Scale
timeFrame: The three after admission
Other outcomes:
measure: Number of Participants with Adverse Events
timeFrame: The two week
Locations:
Study officials:
References:
citation: Liu CH, Hsieh YT, Tseng HP, Lin HC, Lin CL, Wu TY, Lin SH, Tsao SH, Zhang H. Acupuncture for a first episode of acute ischaemic stroke: an observer-blinded randomised controlled pilot study. Acupunct Med. 2016 Oct;34(5):349-355. doi: 10.1136/acupmed-2015-010825. Epub 2016 Apr 19.