Clinical trial NCT02975362: Acupuncture Treatment on Motor Dysfunction in Stroke Patients
Official title: Standardized Treatment of Acupuncture on Motor Dysfunction in Stroke Patients: a Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Motor Disorders
Keywords: Acupuncture Treatment; Motor Dysfunction; Stroke Patients
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2016-11-29
Enrollment: 240
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this proposed study is to determine whether acupuncture combined with rehabilitation treatment could improve significantly motor function in ischemic stroke patients. In this 8-week, assessor-blind, a Multi-center randomized, controlled study of acupuncture as additional treatment with the rehabilitation treatment, a total of 240 patients with stroke patients will be recruited. The patients will be randomly assigned to acupuncture combined with rehabilitation treatment (n =120) or rehabilitation treatment (n =120). (40 sessions, 5 sessions a week). Changes in the motor function over time are measured using Fugl-Meyer Scale and Modified Barthel Index. Change in the stroke syndromes over time are measured using stroke syndrome of TCM Scale. Change in the quality of life over time are measured using SS-QOL scale. The study will be conducted at Shanghai University of Traditional Chinese Medicine, Long Hua Hospital, Fudan University, Hua Shan Hospital.

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. 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 acupuncture combined with rehabilitation treatment could improve significantly motor function in ischemic stroke patients.

In this 8-week, assessor-blind, a Multi-center randomized, controlled study of acupuncture as additional treatment with the rehabilitation treatment, a total of 240 patients with stroke patients will be recruited. The patients will be randomly assigned to acupuncture combined with rehabilitation treatment (n =120) or rehabilitation treatment (n =120). (40 sessions, 5 sessions a week). Changes in the motor function over time are measured using Fugl-Meyer Scale and Modified Barthel Index. Change in the stroke syndromes over time are measured using stroke syndrome of TCM Scale. Change in the quality of life over time are measured using SS-QOL scale.The study will be conducted at Shanghai University of Traditional Chinese Medicine, Long Hua Hospital, Fudan University, Hua Shan Hospital.

Eligibility criteria: Inclusion Criteria:

* The ages of stroke patients from 45 years old to 80 years old.
* The principle diagnosis according to \<diagnosis-treatment criteria of stroke(trial implementation)\>formulated by Collaboration Acute Brain Diseases of State Administration of Traditional Chinese Medicine in 1996；Ischemic stroke confirmed by CT brain or MRI brain, with stable medical condition and awareness clear.
* Recent stroke from 6month to 12 months after onset.
* Stroke with limb motor dysfunction.
* Sufficient cognition to follow commands and Mini-Mental State Examination (MMSE) score \> 24.
* All the patients sign a consent form.

Exclusion Criteria:

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

Primary outcomes:
measure: Change from Baseline FMA at 4 weeks, 8 weeks,6 months
timeFrame: The FMA will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).
Secondary outcomes:
measure: Change from Baseline SS-QOL at 4 weeks, 8 weeks,6 months
timeFrame: The SS-QOL will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).
measure: Change from Baseline MBI at 4 weeks, 8 weeks,6 months
timeFrame: The MBI will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).
measure: Change from Baseline SSTCM at 4 weeks, 8 weeks,6 months
timeFrame: The SSTCM will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Longhua Hospital, Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Jian Pei, MD
role: STUDY_CHAIR
References: