A Randomized Controlled Study of the Effectiveness of Scalp Electroacupuncture in Improving Upper Limb Motor Function in Convalescent Phase of Ischemic Stroke.

NCT ID: NCT02850198

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2020-12-31

Brief Summary

This research is primary to compare effectiveness of scalp electroacupuncture and scalp acupuncture on motor function of the upper limb(UL) in convalescence phase of ischemic stroke. The clinical research is a randomized controlled trial (RCT),consisting of two arms of scalp electroacupuncture group and sham sclp electroacupuncture group to value difference of upper limb function after 4 weeks. The result indicates that scalp electroacupuncture is more sufficient to alter function. The purpose is to value effectiveness of scalp electroacupuncture on motor function of the upper limb in convalescence phase of ischemic stroke.

Detailed Description

Upper limb(UL) impairment is common in patients of ischemic stroke and recovery of motor function is important for regaining independence in activities of daily living. Researches show that the death toll of people who suffering from stroke more than 200 millions,the annual growth rate of this data reached 8.7%, which ischemic stroke take percentage of 60-70, and who suffered from UL impairment reached about 70%. Nowadays, morbidity of ischemic stroke of China is the first of the world.

Aging is a risk for ischemic stroke，especially over the age of 50 years old, which will increase morbidity rate of UL motor function impairment.

UL dysfunction make patients despaired and can not attend social activity normally, decreasing the quality of their lives. Attending social activity is very important for people's health, otherwise, people will get a series of diseases, like disability, depressive disorder,etc.

This subject is primary to compare effectiveness of scalp electroacupuncture and scalp acupuncture on motor function of the UL in convalescence phase of ischemic stroke. The clinical research is a randomized controlled trial (RCT),consisting of two arms of scalp electroacupuncture group and sham sclp electroacupuncture group to value difference of upper limb function after 4 weeks. The result indicates that scalp electroacupuncture is more sufficient to alter function.

As a further study, this research contains two parallel arms of scalp electroacupuncture group and sham sclp electroacupuncture group. The purpose is to value effectiveness of scalp electroacupuncture on motor function of the UL in convalescence phase of ischemic stroke, comparing with sham scalp electroacupuncture.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Scalp electroacupuncture group

Select a 1.5 cun long disposable sterile filiform needle NO.30.Divide the Anterior oblique line of the vertex-temporal in ipsilesional into three equal parts to accept acupuncture.Insert the needle subcutaneously at a 30°angle to the scalp.The depth of insertion is 1 cun.The needle is twirled continuously at a frequency of about 170 times per minute.When the acupuncture sensation is obtained,connect the positive and negative outputs of the electroacupuncture to the handle of the needle in the Anterior oblique line of upper 1/3 and the middle 1/3. Select an sparse-dense wave .Use the low frequency electroacupuncture which the frequency is 2Hz. Every session lasts for 30 min per day.The treatment must be given once daily and 5 sessions constitute one therapeutic course.There is 2 days for relaxation between the two therapeutic courses.The participants must be treated for 4 weeks.

Group Type: EXPERIMENTAL

scalp electroacupuncture

Intervention Type: DEVICE

Sham scalp electroacupuncture group

Select a 1.5 cun long disposable sterile filiform needle NO.30.Divide the Anterior oblique line of the vertex-temporal in ipsilesional into three equal parts to accept acupuncture.Insert the needle subcutaneously at a 30°angle to the scalp.The depth of insertion is 1 cun.The needle is twirled continuously at a frequency of about 170 times per minute.When the acupuncture sensation is obtained,connect the positive and negative outputs of the electroacupuncture to the handle of the needle in the Anterior oblique line of upper 1/3 and the middle 1/3. with shame electroacupuncture. Select an sparse-dense wave .Use the low frequency electroacupuncture which the frequency is 2Hz. Every session lasts for 30 min per day.The treatment must be given once daily and 5 sessions constitute one therapeutic course.There is 2 days for relaxation between the two therapeutic courses.The participants must be treated for 4 weeks.

Group Type: SHAM_COMPARATOR

sham scalp electroacupuncture

Intervention Type: DEVICE

Interventions

scalp electroacupuncture

Intervention Type: DEVICE

sham scalp electroacupuncture

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 2 weeks to 6 months after Ischemic Stroke Experiencing motor difficulties in using the paretic arm, with a FMA-UE score in the range of 20 to 40 out of 66 Signing of the informed consent form indicating that the subject has understood the aim of the study as well as the procedures involved and that he/she accepts to participate and to comply with the demands and restrictions inherent to the study.

Exclusion Criteria

• Any medical condition compromising the safety or the ability to take part to The study (such as insufficient vision or hearing, inability to participate to therapy session, inability to communicate, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity) Recurrent and moderate to high upper limb pain limiting delivery of rehabilitation doseHistory of more than one epileptic seizures since stroke onset or uncontrolled epileptic seizure Mild to severe cognitive impairment (Mini mental state exam (MMSE) score <24/30) Depression (Hospital Anxiety and Depression Scale >8/21) Moderate to severe hemispatial neglect compromising the ability to take part to the study, as determined by the Bells tests (>6 errors) Brain stem stroke Had been diagnosed with hemorrhagic stroke. Had contraindications to electroacupuncture and MRI.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaanxi Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Tong sheng Su, Master

Role: CONTACT

chinasuts@126.com

+0086-15929562568

Other Identifiers

201507001-05-01

Identifier Type: -

Identifier Source: org_study_id