StrokeNCT02975362
Acupuncture Treatment on Motor Dysfunction in Stroke Patients
A study testing Acupuncture Treatment and Rehabilitation Treatment in people with Stroke and Motor Disorders, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Stroke, Motor Disorders
- What is being tested?
- Acupuncture Treatment and Rehabilitation Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Standardized Treatment of Acupuncture on Motor Dysfunction in Stroke Patients: a Multi-center Randomized Controlled Trial
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.
Read the 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
- Being tested
- Acupuncture Treatment, Rehabilitation Treatment
- Keywords
- Acupuncture Treatment; Motor Dysfunction; Stroke Patients
- Medical subject headings
- Stroke, Motor Disorders, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture TreatmentOther
Also called Acupuncture
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 TreatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture combined rehabilitation | Experimental | Acupuncture Treatment Rehabilitation Treatment Receives: Other: Acupuncture Treatment |
| Rehabilitation | Experimental | Rehabilitation Treatment Receives: Other: Rehabilitation Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: The SSTCM will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Jian Pei, MD, Study chair, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975362
- Sponsor's protocol ID
- 1640197030
- Status last verified
- Oct 2022
- First submitted
- 23 Nov 2016
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Treatment of Acupuncture on Motor Dysfunction in Stroke Patients: a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02975362
- Acronym / sponsor ID
- 1640197030
- Conditions
- Stroke, Motor Disorders
- Keywords
- Acupuncture Treatment; Motor Dysfunction; Stroke Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- Dec 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture combined rehabilitation | Experimental | Other: Acupuncture TreatmentAcupuncture Treatment Rehabilitation Treatment |
| Rehabilitation | Experimental | Other: Rehabilitation TreatmentRehabilitation Treatment |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture TreatmentAlso: AcupunctureAcupuncture 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. | Other | Acupuncture combined rehabilitation |
| Rehabilitation TreatmentRehabilitation 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 | Other | Rehabilitation |
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
3 secondary outcomes
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Pei, MD study chair
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Treatment and Rehabilitation Treatment in people with Stroke and Motor Disorders, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.