A Randomized Controlled Study of the Effectiveness of Scalp Electroacupuncture in Improving Upper Limb Motor Function in Convalescent Phase of Ischemic Stroke.
1 other identifier
interventional
328
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2016
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2016
CompletedFirst Posted
Study publicly available on registry
July 29, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 26, 2019
July 1, 2016
4.3 years
July 25, 2016
February 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of upper limb spasm during flexion and extension of the elbow and wrist with Modified Ashworth scale.
4 weeks
Secondary Outcomes (1)
Evaluation of upper limb motor function with Fugl-meyer scale.
4 weeks
Study Arms (2)
Scalp electroacupuncture group
EXPERIMENTALSelect 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.
Sham scalp electroacupuncture group
SHAM COMPARATORSelect 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2016
First Posted
July 29, 2016
Study Start
August 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
February 26, 2019
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will share