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Status unknownNCT02850198Updated Feb 26, 2019

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

An interventional study of scalp electroacupuncture and sham scalp electroacupuncture in Ischemic Stroke, sponsored by Shaanxi Hospital of Traditional Chinese Medicine. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by Shaanxi Hospital of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
328
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ischemic Stroke

Keywords

  • ischemic stroke
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 328 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Shaanxi Hospital of Traditional Chinese Medicine is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
328 participants (estimated)

Study arms

  • Experimental
    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.

    Device: scalp electroacupuncture

  • Sham comparator
    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.

    Device: sham scalp electroacupuncture

Interventions

  • Devicescalp electroacupuncture
  • Devicesham scalp electroacupuncture
06

What researchers measure

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

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

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02850198
Lead sponsor
Shaanxi Hospital of Traditional Chinese Medicine
Responsible party
Sponsor
First posted
Jul 29, 2016
Start date
Aug 2016
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Feb 26, 2019

Study contacts

Tong sheng Su, Master
Contact
chinasuts@126.com
+0086-15929562568

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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