Acupuncture Treatment on Motor Dysfunction in Stroke Patients

NCT02975362 | Unknown DMC

• 1 other identifier: 1640197030
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Motor Disorders

Keywords

Acupuncture Treatment; Motor Dysfunction; Stroke Patients

Outcome Measures

Primary Outcomes (1)

• Change from Baseline FMA at 4 weeks, 8 weeks,6 months

  The Fugl-Meyer Assessment (FMA) scale for motor function, the FMA was developed as the first quantitative evaluative instrument for measuring sensorimotor stroke recovery, which includes an assessment of the upper extremity (UE, 66 points) and lower extremity (LE, 34 points). The motor domain has well-established reliability and validity as an indicator of motor impairment severity across different stroke recovery time points

  The FMA will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).

Secondary Outcomes (3)

• 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).

• 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).

• 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).

Study Arms (2)

Acupuncture combined rehabilitation

EXPERIMENTAL

Acupuncture Treatment Rehabilitation Treatment

Other: Acupuncture Treatment

Rehabilitation

EXPERIMENTAL

Rehabilitation Treatment

Other: Rehabilitation Treatment

Interventions

Acupuncture Treatment 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.

Also known as: Acupuncture

Acupuncture combined rehabilitation

Rehabilitation Treatment 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

Rehabilitation

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Fudan University: collaborator

Study Sites (1)

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Stroke; Motor Disorders; Neurologic Manifestations

Interventions

Acupuncture Therapy; Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jian Pei, MD

  Shanghai University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 29, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

CN (1)