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

Primary Purpose

Ischemic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
scalp electroacupuncture
sham scalp electroacupuncture
Sponsored by
Shaanxi Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring ischemic stroke

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Scalp electroacupuncture group

    Sham scalp electroacupuncture group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Evaluation of upper limb spasm during flexion and extension of the elbow and wrist with Modified Ashworth scale.

    Secondary Outcome Measures

    Evaluation of upper limb motor function with Fugl-meyer scale.

    Full Information

    First Posted
    July 25, 2016
    Last Updated
    February 25, 2019
    Sponsor
    Shaanxi Hospital of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02850198
    Brief Title
    A Randomized Controlled Study of the Effectiveness of Scalp Electroacupuncture in Improving Upper Limb Motor Function in Convalescent Phase of Ischemic Stroke.
    Official Title
    A Randomized Controlled Study of the Effectiveness of Scalp Electroacupuncture in Improving Upper Limb Motor Function in Convalescent Phase of Ischemic Stroke.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shaanxi Hospital of Traditional Chinese Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Stroke
    Keywords
    ischemic stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    328 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Scalp electroacupuncture group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Sham scalp electroacupuncture group
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    scalp electroacupuncture
    Intervention Type
    Device
    Intervention Name(s)
    sham scalp electroacupuncture
    Primary Outcome Measure Information:
    Title
    Evaluation of upper limb spasm during flexion and extension of the elbow and wrist with Modified Ashworth scale.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Evaluation of upper limb motor function with Fugl-meyer scale.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tong sheng Su, Master
    Phone
    +0086-15929562568
    Email
    chinasuts@126.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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