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

Shanghai University of Traditional Chinese Medicine

Status: Unknown

Conditions: Ischemic Stroke; Hemiplegia

Treatments: Other: Rehabilitation treatment; Device: Scalp Acupuncture Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02871453

ZYSNXD-CC-HPGC-JD-004

Details and patient eligibility

About

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.

Full 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 scalp acupuncture treatment could improve significantly motor function in ischemic stroke patients.

In this 8-week, assessor-blind, randomized, controlled study of scalp acupuncture as additional treatment with the rehabilitation treatment, a total of 116 patients with ischemic stroke patients will be recruited. The patients will be randomly assigned to scalp acupuncture combined with rehabilitation treatment (n =58) or rehabilitation treatment (n =58). (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.

Enrollment: 116 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The ages of stroke patients from 40 years old to 70 years old
2. Stroke diagnosed according to the criteria of cerebral arterial thrombosis in Western medicine and apoplexy in Chinese medicine
3. Ischemic stroke confirmed by CT brain or MRI brain, with stable medical condition and awareness clear
4. Recent stroke from 1 month to 6 months after onset
5. Stroke with limb motor dysfunction
6. Sufficient cognition to follow commands and Mini-Mental State Examination (MMSE) score > 24
7. Voluntary participation and informed consent signed.

Exclusion criteria

1. Stroke with conscious disturbance or serious cognitive impairment
2. Presence of another chronic disorder, including severe Parkinson's disease, cardiac disease, cancers, epilepsy, or chronic alcoholism
3. Impaired hepatic or renal function
4. bleeding tendency
5. Being oversensitive to acupuncture
6. participation in another clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

Acupuncture combined rehabilitation

Experimental group

Description:

Scalp acupuncture treatment Rehabilitation treatment

Treatment:

Device: Scalp Acupuncture Treatment

Rehabilitation

Experimental group

Description:

Rehabilitation treatment

Treatment:

Other: Rehabilitation treatment