Clinical Trial: Acupuncture Treatment on Motor Dysfunction in Stroke Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Standardized Treatment of Acupuncture on Motor Dysfunction in Stroke Patients: a Multi-center Randomized Controlled Trial

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 Summary:

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.


Sponsor: Shanghai University of Traditional Chinese Medicine

Current Primary Outcome: Change from Baseline FMA at 4 weeks, 8 weeks,6 months [ Time Frame: The FMA will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (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


Original Primary Outcome: Change from Baseline FMA at 4 weeks, 8 weeks [ Time Frame: The FMA will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (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


Current Secondary Outcome:

  • Change from Baseline SS-QOL at 4 weeks, 8 weeks,6 months [ Time Frame: The SS-QOL will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months). ]
    The Stroke-Specific Quality of Life Scale (SS-QOL) is a patient-reported outcome measure intended to provide an assessment of health-related quality of life, specific to patients with stroke. The SS-QOL questionnaire consists of 49 items in the 12 domains of energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, and work. Scoring of the SS-QOL is rated on a 5-point Likert scale. Response options are scored as 5 ("no help needed/no trouble at all/strongly disagree"), 4 ("a little help/a little trouble/moderately disagree"), 3 ("some help/some trouble/neither agree nor disagree"), 2 ("a lot of help/a lot of trouble/moderately agree"), and 1 ("total help/could not do it at all/strongly agree"). The domains are scored separately, and a total score is also calculated, with higher scores indicating better function.
  • Change from Baseline MBI at 4 weeks, 8 weeks,6 months [ Time Frame: The MBI will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months). ]
    The Barthel Index(BI) is a scale that measures ten basic aspects of activity daily living related to self-care and mobility. For the Chinese Modified Barthel Index(MBI) version, the ten items are: continence of bowels and bladder, feeding, dressing, transferring to and from a toilet, grooming, bathing, moving from wheelchair to bed and return, walking on level surface for 45 meters, and ascend and descend stairs. Standard for Evaluation：Each item (activity) be divided into 5 levels, different level represents a different degree of independence, the lowest level is 1 and the highest level is 5.The more higher level, more independence. The normal score is 100. If a person score is 100, he is able to get along without attendant care.
  • Change from Baseline SSTCM at 4 weeks, 8 weeks,6 months [ Time Frame: The SSTCM will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months). ]
    The Stroke Syndrome of TCM (SSTCM) was developed mainly based on quantified index of TCM symptoms. The SSTCM includes signs and symptoms which were the most concern of the patients and doctors themselves after stroke. SSTCM mainly consists of two domains: TCM symptoms and pulse conditions and tongue pictures. TCM symptoms area contains 24 items. The assessment standards of each item was divided into four levels and corresponding scores (normal = 0, light = 1, middle=2, heavy = 3) according different degree base on the severity of the symptoms and the impacts on life. Pulse conditions and tongue pictures record contents only, not to score. The total score is calculated from the domain one, with lower scores indicating the lighter degree of the symptom severity and the less impact on life. The SSTCM was evaluated by experienced traditional Chinese medicine doctors who were accepted the unification of assessment training.


Original Secondary Outcome:

  • Change from Baseline SS-QOL at 4 weeks, 8 weeks [ Time Frame: The SS-QOL will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months). ]
    The Stroke-Specific Quality of Life Scale (SS-QOL) is a patient-reported outcome measure intended to provide an assessment of health-related quality of life, specific to patients with stroke. The SS-QOL questionnaire consists of 49 items in the 12 domains of energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, and work. Scoring of the SS-QOL is rated on a 5-point Likert scale. Response options are scored as 5 ("no help needed/no trouble at all/strongly disagree"), 4 ("a little help/a little trouble/moderately disagree"), 3 ("some help/some trouble/neither agree nor disagree"), 2 ("a lot of help/a lot of trouble/moderately agree"), and 1 ("total help/could not do it at all/strongly agree"). The domains are scored separately, and a total score is also calculated, with higher scores indicating better function.
  • Change from Baseline MBI at 4 weeks, 8 weeks [ Time Frame: The MBI will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months). ]
    The Barthel Index(BI) is a scale that measures ten basic aspects of activity daily living related to self-care and mobility. For the Chinese Modified Barthel Index(MBI) version, the ten items are: continence of bowels and bladder, feeding, dressing, transferring to and from a toilet, grooming, bathing, moving from wheelchair to bed and return, walking on level surface for 45 meters, and ascend and descend stairs. Standard for Evaluation：Each item (activity) be divided into 5 levels, different level represents a different degree of independence, the lowest level is 1 and the highest level is 5.The more higher level, more independence. The normal score is 100. If a person score is 100, he is able to get along without attendant care.
  • Change from Baseline SSTCM at 4 weeks, 8 weeks [ Time Frame: The SSTCM will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months). ]
    The Stroke Syndrome of TCM (SSTCM) was developed mainly based on quantified index of TCM symptoms. The SSTCM includes signs and symptoms which were the most concern of the patients and doctors themselves after stroke. SSTCM mainly consists of two domains: TCM symptoms and pulse conditions and tongue pictures. TCM symptoms area contains 24 items. The assessment standards of each item was divided into four levels and corresponding scores (normal = 0, light = 1, middle=2, heavy = 3) according different degree base on the severity of the symptoms and the impacts on life. Pulse conditions and tongue pictures record contents only, not to score. The total score is calculated from the domain one, with lower scores indicating the lighter degree of the symptom severity and the less impact on life. The SSTCM was evaluated by experienced traditional Chinese medicine doctors who were accepted the unification of assessment training.


Information By: Shanghai University of Traditional Chinese Medicine

Dates:
Date Received: November 23, 2016
Date Started: December 2016
Date Completion: December 2019
Last Updated: February 12, 2017
Last Verified: November 2016