Evaluating the Therapeutic Effect of Scalp Acupuncture Treatment for Motor Dysfunction in Ischemic Stroke Patients

Recruiting

Phase N/A Results N/A

Trial Description

The investigators design a randomized, control study to evaluate the therapeutic effect of scalp acupuncture using Jiao's motor area for motor dysfunction in ischemic stroke patients using the following outcomes: motor function, activity of daily living,quality of life.

Detailed Description

Functional disorder is a common and serious consequence of stroke. A large proportion of stroke patients develop motor dysfunction in the early stage after stroke. Acupuncture is often used as an adjunct to mainstream rehabilitation after stroke. Jiao's scalp acupuncture is a contemporary acupuncture technique integrating traditional Chinese needling methods with western medical knowledge of representative areas of the cerebral cortex. It has been widely applied to be a kind of effective treatment for stroke in China. But, there is meta-analysis suggests that with stroke rehabilitation, acupuncture has no additional effect on motor recovery but has a small positive effect on disability, which may be due to a true placebo effect and varied study quality. The efficacy of acupuncture without stroke rehabilitation remains uncertain, mainly because of the poor quality of such studies.
The objective of this proposed study is to determine whether Jiao's scalp acupuncture treatment could improve significantly motor function in ischemic stroke patients.
In this 8-week, assessor-blind, randomized, controlled study of Jiao's scalp acupuncture as additional treatment with the rehabilitation treatment, a total of 100 patients with ischemic stroke patients will be recruited. The patients will be randomly assigned to Jiao's scalp acupuncture combined with rehabilitation treatment (n =50) or rehabilitation treatment (n =50). (40 sessions, 5 sessions a week). Changes in the motor function over time are measured using Fugl-Meyer Scale, Modified Barthel Index and SS-QOL scale. The study will be conducted at Shanghai University of Traditional Chinese Medicine, Long Hua Hospital, Fudan University, Hua Shan Hospital.

Conditions

Interventions

  • Rehabilitation treatment Other
    Intervention Desc: The rehabilitation program was designed according to the Chinese stroke rehabilitation treatment guidelines, which included physical therapy (PT) and occupational therapy (OT). The rehabilitation programs will be carried out five times a week (that is, Monday to Friday) for 8 weeks, and every time the rehabilitation treatment( PT and OT) will last approximately for 1 hour. All rehabilitation treatment will be carried out by qualified therapists.
    ARM 1: Kind: Experimental
    Label: Rehabilitation
    Description: Rehabilitation treatment
  • Scalp Acupuncture Treatment Device
    Other Names: Acupuncture
    Intervention Desc: The Motor Area of the Jiao's scalp acupuncture is located over the anterior central convolution of the cerebral cortex, being a line starting from a point 0.5cm posterior to the midpoint of the anterior-posterior midline of the head and stretching diagonally to the juncture between the eyebrow-occipital line and the anterior border of the corner of temporal hairline is indistinct, draw a vertical line upward from the middle point of the zygomatic arch to the eyebrow-occipital line, the intersection of the two lines is the projection of the Motor Area. Needles will be inserted in an about 15 degree angle to a depth of 1.0-1.5cm. Needles are rotated at least 200 revolutions per minute for 1 minute every 10 minutes for a total of 60 minutes. five times a week, 8 weeks in total.
    ARM 1: Kind: Experimental
    Label: Acupuncture combined rehabilitation
    Description: Scalp acupuncture treatment Rehabilitation treatment

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from Baseline FMA at 4 weeks, 8 weeks The FMA will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months). No
Secondary Change from Baseline MBI at 4 weeks, 8 weeks The MBI will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months). No
Secondary Change from Baseline SS-QOL at 4 weeks, 8 weeks The SS-QOL will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months). No
Secondary Change from Baseline SSTCM at 4 weeks, 8 weeks The SSTCM will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months). No

Sponsors