Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients

Acute Stroke Clinical Trial

Official title:

Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210988
• Other study ID #: CGHIRBCT-P-100002
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2014
• Source: Cathay General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Stroke
• Ischemic Stroke
• Stroke

Intervention

Other:
• acupuncture
Intervention with acupuncture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cathay General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Adverse Events	Adverse events was monitored in each acupuncture maneuver and post therapeutic course two weeks later.	The two week
Primary	National Institute of Health Stroke Scale		the fourth week
Primary	Fugal-Mayer Assessment		The fourth week
Primary	Functional Independent Measure		The fourth week
Secondary	National Institute of Health Stroke Scale		The three months after admission
Secondary	Barthel index		The three month after admission
Secondary	Modified Rankin Scale		The three after admission