NCT02612441

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2017

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

November 10, 2015

Last Update Submit

April 4, 2019

Conditions

Keywords

stroke

Outcome Measures

Primary Outcomes (1)

  • (NIHSS)

    1 week

Study Arms (2)

1 real Acupuncture group-intervention

EXPERIMENTAL

real Acupuncture Needles

Device: real Acupuncture Needles

2 sham Acupuncture group

SHAM COMPARATOR

sham Acupuncture Needles

Device: sham Acupuncture Needles

Interventions

Acupuncture needles

1 real Acupuncture group-intervention

sham Acupuncture Needles

2 sham Acupuncture group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical center, Neurology Department

Haifa, Israel

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2015

First Posted

November 23, 2015

Study Start

November 1, 2015

Primary Completion

October 22, 2017

Study Completion

October 22, 2017

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations