Acupuncture Treatment on Motor Dysfunction in Stroke Patients

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Rehabilitation treatment Other
    Intervention Desc: Rehabilitation treatment 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
  • Acupuncture Treatment Other
    Other Names: Acupuncture
    Intervention Desc: Acupuncture Treatment Acupoint selection base on disease stage combined adjunct acupuncture acupoint base on syndrome differentiation.①Base on disease stage: Flaccid paralysis period: DU24, DU20, Motor Area , LI15, LI14, LI11, SJ5, LI4, GB31, EX-LE2, GB34, ST36, ST40.Spastic period: DU24, DU20, Motor Area , SJ10, SJ13, LI10, SJ8, SJ5, SJ4, SJ4, BL37, BL40, BL39, BL55, BL57, ST41, GB40, BL60.②Base on syndrome differentiation:Excess syndrome of yang-type: LR3, ST37; Deficiency syndrome of Yang-type: KI3, BL23; Excess syndrome of yin-type: SP9, GB20;Deficiency syndrome of Yin-type: CV6, BL23.③Electroacupuncture acupoint: Flaccid paralysis period: LI15, LI4, GB31, ST40; Spastic period: SJ13, SJ5, BL40, BL57.30minutes each time,twenty times / treatment course,two treatment courses in total.
    ARM 1: Kind: Experimental
    Label: Acupuncture combined rehabilitation
    Description: Acupuncture Treatment Rehabilitation Treatment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from Baseline FMA at 4 weeks, 8 weeks,6 months The FMA will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).
Secondary Change from Baseline SS-QOL at 4 weeks, 8 weeks,6 months The SS-QOL will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).
Secondary Change from Baseline MBI at 4 weeks, 8 weeks,6 months The MBI will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).
Secondary Change from Baseline SSTCM at 4 weeks, 8 weeks,6 months The SSTCM will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).

Sponsors