Ischemic StrokeNCT02871453
Evaluating the Therapeutic Effect of Scalp Acupuncture Treatment for Motor Dysfunction in Ischemic Stroke Patients
A study testing Scalp Acupuncture Treatment and Rehabilitation treatment in people with Ischemic Stroke and Hemiplegia, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The investigators design a randomized, control study to evaluate the therapeutic effect of scalp acupuncture using Jiao's motor area for motor dysfunction in ischemic stroke patients using the following outcomes: motor function, activity of daily living,quality of life. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Ischemic Stroke, Hemiplegia
- What is being tested?
- Scalp Acupuncture Treatment and Rehabilitation treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2020
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The ages of stroke patients from 40 years old to 70 years old
- Stroke diagnosed according to the criteria of cerebral arterial thrombosis in Western medicine and apoplexy in Chinese medicine
- Ischemic stroke confirmed by CT brain or MRI brain, with stable medical condition and awareness clear
- Recent stroke from 1 month to 6 months after onset
- Stroke with limb motor dysfunction
- Sufficient cognition to follow commands and Mini-Mental State Examination (MMSE) score > 24
- Voluntary participation and informed consent signed.
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
- bleeding tendency
- Being oversensitive to acupuncture
- participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Jian Pei, MD, +86 21 6438 5700 ext. 3534, jianpei99@yahoo.com
Jun Wang, MM
About this study
Official title: Scalp Acupuncture for Motor Dysfunction in Ischemic Stroke: a Randomized, Controlled Trial
The investigators design a randomized, control study to evaluate the therapeutic effect of scalp acupuncture using Jiao's motor area for motor dysfunction in ischemic stroke patients using the following outcomes: motor function, activity of daily living,quality of life.
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. Jiao's scalp acupuncture is a contemporary acupuncture technique integrating traditional Chinese needling methods with western medical knowledge of representative areas of the cerebral cortex. 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 scalp acupuncture treatment could improve significantly motor function in ischemic stroke patients.
In this 8-week, assessor-blind, randomized, controlled study of scalp acupuncture as additional treatment with the rehabilitation treatment, a total of 116 patients with ischemic stroke patients will be recruited. The patients will be randomly assigned to scalp acupuncture combined with rehabilitation treatment (n =58) or rehabilitation treatment (n =58). (40 sessions, 5 sessions a week). Changes in the motor function over time are measured using Fugl-Meyer Scale, Modified Barthel Index and SS-QOL scale. The study will be conducted at Shanghai University of Traditional Chinese Medicine, Long Hua Hospital, Fudan University, Hua Shan Hospital.
- Conditions
- Ischemic Stroke, Hemiplegia
- Being tested
- Scalp Acupuncture Treatment, Rehabilitation treatment
- Keywords
- Ischemic Stroke, Motor Dysfunction, Scalp Acupuncture
- Medical subject headings
- Ischemic Stroke, Hemiplegia, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp Acupuncture TreatmentDevice
Also called Acupuncture
The Motor Area of the scalp acupuncture is located over the anterior central convolution of the cerebral cortex, being a line starting from a point 0.5cm posterior to the midpoint of the anterior-posterior midline of the head and stretching diagonally to the juncture between the eyebrow-occipital line and the anterior border of the corner of temporal hairline is indistinct, draw a vertical line upward from the middle point of the zygomatic arch to the eyebrow-occipital line, the intersection of the two lines is the projection of the Motor Area. Needles will be inserted in an about 15 degree angle to a depth of 1.0-1.5cm. Needles are rotated at least 200 revolutions per minute for 1 minute every 10 minutes for a total of 60 minutes. five times a week, 8 weeks in total.
Rehabilitation treatmentOther
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 | Scalp acupuncture treatment
Rehabilitation treatment Receives: Device: Scalp 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
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 (1 month, 2 months).
Secondary outcomes (3)
Change from Baseline MBI at 4 weeks, 8 weeks
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 (1 month, 2 months).
Change from Baseline SS-QOL at 4 weeks, 8 weeks
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 (1 month, 2 months).
Change from Baseline SSTCM at 4 weeks, 8 weeks
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 (1 month, 2 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic 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
- 116 participants (estimated)
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
- NCT02871453
- Sponsor's protocol ID
- ZYSNXD-CC-HPGC-JD-004
- Status last verified
- Feb 2020
- First submitted
- 17 Jul 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wang J, Pei J, Khiati D, Fu Q, Cui X, Song Y, Yan M, Shi L, Cai Y, Ma Y. Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial. Trials. 2017 Jun 20;18(1):287. doi: 10.1186/s13063-017-2000-x.
PubMed 28633675
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalp Acupuncture for Motor Dysfunction in Ischemic Stroke: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02871453
- Acronym / sponsor ID
- ZYSNXD-CC-HPGC-JD-004
- Conditions
- Ischemic Stroke, Hemiplegia
- Keywords
- Ischemic Stroke, Motor Dysfunction, Scalp Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- Jan 2015
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Aug 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 investigators design a randomized, control study to evaluate the therapeutic effect of scalp acupuncture using Jiao's motor area for motor dysfunction in ischemic stroke patients using the following outcomes: motor function, activity of daily living,quality of life.
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. Jiao's scalp acupuncture is a contemporary acupuncture technique integrating traditional Chinese needling methods with western medical knowledge of representative areas of the cerebral cortex. 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 scalp acupuncture treatment could improve significantly motor function in ischemic stroke patients.
In this 8-week, assessor-blind, randomized, controlled study of scalp acupuncture as additional treatment with the rehabilitation treatment, a total of 116 patients with ischemic stroke patients will be recruited. The patients will be randomly assigned to scalp acupuncture combined with rehabilitation treatment (n =58) or rehabilitation treatment (n =58). (40 sessions, 5 sessions a week). Changes in the motor function over time are measured using Fugl-Meyer Scale, Modified Barthel Index and 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 | Device: Scalp Acupuncture TreatmentScalp acupuncture treatment Rehabilitation treatment |
| Rehabilitation | Experimental | Other: Rehabilitation treatmentRehabilitation treatment |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The ages of stroke patients from 40 years old to 70 years old
- Stroke diagnosed according to the criteria of cerebral arterial thrombosis in Western medicine and apoplexy in Chinese medicine
- Ischemic stroke confirmed by CT brain or MRI brain, with stable medical condition and awareness clear
- Recent stroke from 1 month to 6 months after onset
- Stroke with limb motor dysfunction
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
- 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 |
|---|---|---|
| Scalp Acupuncture TreatmentAlso: AcupunctureThe Motor Area of the scalp acupuncture is located over the anterior central convolution of the cerebral cortex, being a line starting from a point 0.5cm posterior to the midpoint of the anterior-posterior midline of the head and stretching diagonally to the juncture between the eyebrow-occipital line and the anterior border of the corner of temporal hairline is indistinct, draw a vertical line upward from the middle point of the zygomatic arch to the eyebrow-occipital line, the intersection of the two lines is the projection of the Motor Area. Needles will be inserted in an about 15 degree angle to a depth of 1.0-1.5cm. Needles are rotated at least 200 revolutions per minute for 1 minute every 10 minutes for a total of 60 minutes. five times a week, 8 weeks in total. | Device | Acupuncture combined rehabilitation |
| Rehabilitation treatmentThe 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
Time frame: The FMA will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 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 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 (1 month, 2 months).
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 (1 month, 2 months).
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 (1 month, 2 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 28633675Wang J, Pei J, Khiati D, Fu Q, Cui X, Song Y, Yan M, Shi L, Cai Y, Ma Y. Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial. Trials. 2017 Jun 20;18(1):287. doi: 10.1186/s13063-017-2000-x.
- Individual participant dataSharing planned: No
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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 Scalp Acupuncture Treatment and Rehabilitation treatment in people with Ischemic Stroke and Hemiplegia, 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 7 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 5 Feb 2020. 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?
Contact Jian Pei, MD (021-64385700 ext. 3534, jianpei99@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (1 month, 2 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02871453, which also lists 1 linked publication.
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 5 Feb 2020.