Acupuncture Treatment on Motor Dysfunction in Stroke Patients

NCT ID: NCT02975362

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2022-12-31

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.

Conditions

Stroke; Motor Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acupuncture combined rehabilitation

Acupuncture Treatment Rehabilitation Treatment

Group Type: EXPERIMENTAL

Acupuncture Treatment

Intervention Type: OTHER

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.

Rehabilitation

Rehabilitation Treatment

Group Type: EXPERIMENTAL

Rehabilitation Treatment

Intervention Type: OTHER

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

Interventions

Acupuncture Treatment

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.

Intervention Type: OTHER

Rehabilitation Treatment

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

Intervention Type: OTHER

Other Intervention Names

Acupuncture

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Pei, MD

Role: STUDY_CHAIR

Shanghai University of Traditional Chinese Medicine

Locations

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

1640197030

Identifier Type: -

Identifier Source: org_study_id