Ischemic Stroke Clinical Trial
Official title:
A Randomized Controlled Study of the Effectiveness of Scalp Electroacupuncture in Improving Upper Limb Motor Function in Convalescent Phase of Ischemic Stroke.
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.
Status | Not yet recruiting |
Enrollment | 328 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shaanxi Hospital of Traditional Chinese Medicine |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of upper limb spasm during flexion and extension of the elbow and wrist with Modified Ashworth scale. | 4 weeks | ||
Secondary | Evaluation of upper limb motor function with Fugl-meyer scale. | 4 weeks |
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