Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-11 @ 8:48 PM
Study NCT ID:
NCT03120650
Status:
UNKNOWN
Last Update Posted:
2022-09-07
First Post:
2017-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scalp Acupuncture for Dyskinesia After Ischemic Stroke
Sponsor:
Shanghai University of Traditional Chinese Medicine
Organization:
Study Overview
Official Title:
Scalp Acupuncture for Dyskinesia After Ischemic Stroke
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUSA
Brief Summary:
Scalp acupuncture formed by combining traditional Chinese acupuncture techniques and modern theories in medical anatomy has been widely used to treat ischemic stroke in China, but effective clinical trials that verify its efficacy are lacking. This study proposes to verify the effects of Lu's scalp acupuncture on ischemic stroke by comparing differential improvement of motor function between conventional rehabilitation alone and conventional rehabilitation with Lu's scalp acupuncture.
Detailed Description:
A randomized, controlled, parallel, clinical trial. 116 ischemic stroke patients will be collected with dyskinesia from Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Huashan Hospital, Fudan University in China. All patients will be equally randomized into either a control group (conventional rehabilitation) or an experimental group (scalp acupuncture + conventional rehabilitation). In the control group, patients will receive conventional rehabilitation according to the Guidelines for Stroke Rehabilitation in China. In the experimental group, conventional rehabilitation will be supplemented with oblique acupuncture at approximately 15° and an insertion depth of 25-35 mm in the motor areas of the scalp. Twisting speed will be 200 times per minute. Acupuncture will be performed six times per day in 1-minute bouts, with a 4-minute rest following each bout. Patients in both groups will receive rehabilitation five times per week for 8 consecutive weeks. The primary outcome will be the difference in Fugl-Meyer motor function score between posttreatment (4 weeks, 8 weeks, and 6 months of follow-up) and baseline.
The secondary outcomes will be differences in the Modified Barthel Index, stroke-specific quality of life, and stroke syndrome of traditional Chinese medicine.
The secondary outcomes will be differences in the Modified Barthel Index, stroke-specific quality of life, and stroke syndrome of traditional Chinese medicine.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: