The Efficacy of Acupuncture on Patients With First Acute Ischemic Stroke, With Signs of Hemiplegia and Hemiparesis

NCT ID: NCT02612441

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-10-22

Brief Summary

Chinese Acupuncture can improve the motor ability of patients after having first acute ischemic stroke, in time scale up to 3 weeks from when the ischemic stroke occur and in minimum receiving number of 3 Acupuncture treatments.

The accepted treatment on cerebral vascular accident (CVA) is focus on two lines: the first is the treatment when the stroke occurs, and the second is prevention from having more cerebral vascular accident in the future.

In the first accepted treatment line, the only medicinal measure that stand up in critique of organized researches, is Tissue Plasminogen Activator (TPA), and there is Short and limited time after the CVA occur that it can be used. Also (TPA) can be used only on part of the patients with specific defined criterions.

The aim of this study is to add a new accepted treatment method that appointed to improve the results of acute ischemic stroke by Chinese Acupuncture. The written works on this topic is unambiguously.

Detailed Description

The number of participant in the clinical trial: approximately 100 patients. 50 patients will receive Chinese Acupuncture and the others 50 will receive sham Acupuncture.

Stages and work method:

The treatments in Acupuncture will occur every week. Each patient will receive minimum 3 Acupuncture/ sham treatments while staying in the neurology department.

1 After the suitable patients selected to be included in the study, with the assistance of statistical software, the acupuncturist will get from each patient approval to be participating in the study.

2. The direct physician of all the patients that will be participate in the study will approve the accepted treatment in Acupuncture/ sham and get the patients acceptance by signature.

3. The acupuncturist will receive a list of all the patients after they signed the research agreement forms, and after they have been taking The National Institutes of Health Stroke Scale- (NIHSS) and Medical Research Council (MRC) Scale for Muscle Strength..

4. The first treatment for each patient from each group (real or sham acupuncture), will take approximately 45 minutes and include:

1. the acupuncturist will filling an intake form, according to the principle of Chinese medicine

2. treatment: Staying with needles / sham needles for about 20 minutes. *take notice that the following treatments will take approximately 30 minutes and includes filling brief questions form according to the principle of Chinese medicine and treatment.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 real Acupuncture group-intervention

real Acupuncture Needles

Group Type: EXPERIMENTAL

real Acupuncture Needles

Intervention Type: DEVICE

Acupuncture needles

2 sham Acupuncture group

sham Acupuncture Needles

Group Type: SHAM_COMPARATOR

sham Acupuncture Needles

Intervention Type: DEVICE

sham Acupuncture Needles

Interventions

real Acupuncture Needles

Acupuncture needles

Intervention Type: DEVICE

sham Acupuncture Needles

sham Acupuncture Needles

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All patients with first acute ischemic stroke, with preserved cognitive awareness and with the ability to sign on the research agreement forms.

Division for two main groups:

• Group number 1: will get real Acupuncture
• Group number 2: will get false Acupuncture- ( SHAM).

• The patients will be selected with the assistance of statistical software which will divide them randomly and equally by the standard Criteria.

Exclusion Criteria

• Patients with understanding dysfunction:

• Dysphasia, sensory aphasia,
• Patients with cerebral hemorrhage,
• pregnant women's, children's, and Patients with lack of judgment ability.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rambam Medical center, Neurology Department

Haifa, , Israel

Countries

Israel

Other Identifiers

Acupuncture_neurology_CTIL

Identifier Type: -

Identifier Source: org_study_id