Cerebral InfarctionNCT07140406
Observation of the Therapeutic Effect of Fire Needle on Upper Limb Function in Stroke Patients
A study testing conventional rehabilitation training, conventional acupuncture and Acupuncture with the milli-needle fire-puncture on flexor muscle groups in people with Cerebral Infarction, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Objective: To explore the clinical efficacy of different needling strategies with moxibustion needles on upper limb function in post-stroke patients. Method: 105 patients with upper limb dysfunction after stroke were randomly divided into an extensor treatment group, a flexor treatment group, and a control group, with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- conventional rehabilitation training, conventional acupuncture and Acupuncture with the milli-needle fire-puncture on flexor muscle groups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria.
- The patient had a first stroke and the course of disease was 15 days to 12 months.
- With unilateral disease， the muscular tone assessed by the modified Ashworth scale of upper limb was Ⅰ/Ⅰ+/Ⅱ/Ⅲ level ，Brunnstrom stage in upper limb was Ⅲ/Ⅳ/Ⅴ， Upper limb muscle strength is greater than or equal to grade 2.
- Age 18-70 years old.
- Have not taken Chinese or Western medicine sedatives muscle relaxants or any drugs that have an impact on muscle tone recently.
- Clear consciousness stable vital signs no other acute diseases and serious complications.
- Patients or family members agree to accept this clinical study and have signed informed consent.
Who cannot join
- Bilateral disease.
- History of serious injury or disease of other upper limb nerves muscles or bones.
- Patients with severe cervical spondylosis and hypertension.
- Patients with audiovisual abnormalities severe cognitive impairment and mental diseases who cannot cooperate with the examination.
- Patients with tumor and severe malnutrition.
- There are contraindications for needle treatment such as extreme hunger tension infectious diseases skin collapse etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-dimensional Motion Capture System Combined With sEMG Was Used to Evaluate the Effect of Different Firebone Acupuncture Strategies on Upper Limb Function in Stroke Patients
Objective: To explore the clinical efficacy of different needling strategies with moxibustion needles on upper limb function in post-stroke patients. Method: 105 patients with upper limb dysfunction after stroke were randomly divided into an extensor treatment group, a flexor treatment group, and a control group, with 35 patients in each group. Patients in the extensor treatment group were treated with extensor group moxibustion, patients in the flexor treatment group were treated with flexor group moxibustion, and patients in the control group were treated with conventional moxibustion. Observe the upper limb movement trajectory, surface electromyographic signals (sEMG) of extensor and flexor muscle groups, MAS scale scores, and FMA-UE scores of two groups of patients under specific tasks detected by a three-dimensional motion capture system before and after treatment, and determine the clinical efficacy. Result: Moxibustion therapy with moxibustion is helpful in improving upper limb dysfunction in stroke patients, safe and reliable, and worthy of application. The efficacy of needling the flexor muscle group with moxibustion is better than that of needling the extensor muscle group and conventional acupuncture, providing certain evidence and guidance for the selection of moxibustion sites in clinical practice.
Read the detailed description
105 patients with upper limb dysfunction after stroke were selected according to the inclusion criteria and randomly divided into an extensor treatment group, a flexor treatment group, and a control group of 35 cases each. The patients in the extensor treatment group were treated with routine rehabilitation training+routine acupuncture and moxibustion+millifire needle acupuncture for the extensor muscle group (triceps brachii, forearm extensor muscle group), the patients in the flexor treatment group were treated with routine rehabilitation training+routine acupuncture and moxibustion+millifire needle acupuncture for the flexor muscle group (biceps brachii, forearm flexor muscle group), and the patients in the control group were treated with routine rehabilitation training+routine acupuncture and moxibustion+routine millifire needle acupuncture. The treatment was administered once every other day with a moxibustion needle for a total of 4 weeks. Observe the upper limb movement trajectory, surface electromyographic signals (sEMG) of extensor and flexor muscle groups, changes in MAS scale scores, and FMA-UE scores of two groups of patients under specific tasks detected by a three-dimensional motion capture system before, after one treatment, and after 4 weeks of treatment. Calculate joint angles and motion distances through spatial coordinates, and apply RMS MF、CC、 Coherence analysis quantifies muscle strength, muscle tension, fatigue, and coordination.
- Conditions
- Cerebral Infarction
- Being tested
- conventional rehabilitation training, conventional acupuncture, Acupuncture with the milli-needle fire-puncture on flexor muscle groups, Acupuncture with the milli-needle fire-puncture on extensor muscle groups, Conventional needle puncture with a fire needle
- Keywords
- dysfunction, stroke, fire needle, Surface electromyography, 3D motion capture system
- Medical subject headings
- Cerebral Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional rehabilitation trainingOther
The rehabilitation training is designed based on the specific functional conditions of the patient's limbs. The specific training methods include proper limb positioning, exercise therapy such as passive movement, anti-spasticity training, scapular girdle muscle training, joint extension training, forearm pronation and supination training, occupational therapy, joint movement training, roller treatment, and fine motor skill training, etc. The treatment is conducted once a day and five times a week. The treatment lasts for 4 consecutive weeks.
conventional acupunctureOther
Conventional acupuncture treatment involves needling at acupoints on the upper limbs of patients to improve their upper limb function. The treatment is administered once a day, five times a week, for a continuous period of four weeks.
Acupuncture with the milli-needle fire-puncture on flexor muscle groupsOther
The acupuncture points of the milli-needle fire-puncture device are located in the flexor muscle groups of the upper limbs, including the biceps brachii and the flexor muscle group of the forearm.
Acupuncture with the milli-needle fire-puncture on extensor muscle groupsOther
The acupuncture points for the milli-needle fire-puncture device are located in the extensor muscle groups of the upper limbs, including the triceps brachii and the extensor muscles of the forearm.
Conventional needle puncture with a fire needleOther
The acupuncture points for milli-needle fire-puncture are commonly used ones on the upper limbs.
| Study group | Role | What they receive |
|---|---|---|
| Flexed muscle Milli-fire needle | Experimental | Patients in the flexor treatment group received conventional rehabilitation training, conventional acupuncture, and moxibustion with fine fire needles on the flexor muscle groups (biceps brachii and forearm flexor muscle groups).The Milli-fire needle treatment was administered every other day for a total of 4 weeks. Receives: Other: conventional rehabilitation training; Other: conventional acupuncture; Other: Acupuncture with the milli-needle fire-puncture on flexor muscle groups |
| Extensor muscle Milli-fire needle | Experimental | The patients in the extensor muscle treatment group received conventional rehabilitation training , conventional acupuncture and moxibustion with Milli-fire needle on the extensor muscle groups (triceps brachii, forearm extensor muscles).The Milli-fire needle treatment was administered every other day for a total of 4 weeks. Receives: Other: conventional rehabilitation training; Other: conventional acupuncture; Other: Acupuncture with the milli-needle fire-puncture on extensor muscle groups |
| Control group | Active comparator | Patients in the control group received conventional rehabilitation training, conventional acupuncture, and conventional moxibustion with Milli-fire needle.The acupuncture points for fire needle puncture are commonly used ones on the upper limbs.The Milli-fire needle treatment was administered every other day for a total of 4 weeks. Receives: Other: conventional rehabilitation training; Other: conventional acupuncture; Other: Conventional needle puncture with a fire needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root mean square(RMS) of surface electromyography(sEMG）
Using sEMG the EMG of the upper limb muscles is collected including RMS
Measured: 4 weeks
Secondary outcomes (9)
RMS of sEMG
Using sEMG, the EMG signals of the upper limb muscles are collected, including RMS .
Measured: first day
Mean Frequency (MF)of SEMG
Using sEMG, the EMG signals of the upper limb muscles are collected, including MF.
Measured: first day
Joint angle
Three-dimensional motion capture system was used to detect joint angle .
Measured: first day
Motion distance
Three-dimensional motion capture system was used to detect motion distance.
Measured: first day
Joint angle
Three-dimensional motion capture system was used to detect joint angle .
Measured: 4 weeks
Motion distance
Three-dimensional motion capture system was used to detect motion distance.
Measured: 4 weeks
Fugl-Meyer Assessment Upper Extremity Scale(FMA-UE)
FMA-UE is a commonly used scale for assessing upper limb motor function in stroke patients, mainly evaluating reflex activity, motor control, and muscle strength of the hemiplegic upper limb. FMA-UE includes 33 items related to proximal and distal limb movements of the upper limbs, with each item scored on a scale of 0, 1, and 2. 0 points indicates complete inability to complete, 2 points indicates ability to complete the specified action, and 1 point falls between the two; The total score ranges from 0 to 66 points. The higher the score, the better the upper limb function.
Measured: 4 weeks
Modified Ashworth Scale(MAS)
MAS is a standardized tool for assessing the degree of muscle spasms and has been established as the clinical gold standard in the assessment of limb spasms after stroke. This scale is divided into levels 0-4, with higher levels indicating greater muscle tone.
Measured: 4 weeks
Mean Frequency (MF)of SEMG
Using sEMG, the EMG signals of the upper limb muscles are collected, including MF.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start2 Dec 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhangZhaohui, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140406
- Sponsor's protocol ID
- KYLL-202309-045-2
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The original data will be released on 2026.12.30,and the method will be dislosed through the publishde papers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Motion Capture System Combined With sEMG Was Used to Evaluate the Effect of Different Firebone Acupuncture Strategies on Upper Limb Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT07140406
- Acronym / sponsor ID
- KYLL-202309-045-2
- Conditions
- Cerebral Infarction
- Keywords
- dysfunction, stroke, fire needle, Surface electromyography, 3D motion capture system
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 24 Aug 2025 (actual)
- 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.
Objective: To explore the clinical efficacy of different needling strategies with moxibustion needles on upper limb function in post-stroke patients. Method: 105 patients with upper limb dysfunction after stroke were randomly divided into an extensor treatment group, a flexor treatment group, and a control group, with 35 patients in each group. Patients in the extensor treatment group were treated with extensor group moxibustion, patients in the flexor treatment group were treated with flexor group moxibustion, and patients in the control group were treated with conventional moxibustion. Observe the upper limb movement trajectory, surface electromyographic signals (sEMG) of extensor and flexor muscle groups, MAS scale scores, and FMA-UE scores of two groups of patients under specific tasks detected by a three-dimensional motion capture system before and after treatment, and determine the clinical efficacy. Result: Moxibustion therapy with moxibustion is helpful in improving upper limb dysfunction in stroke patients, safe and reliable, and worthy of application. The efficacy of needling the flexor muscle group with moxibustion is better than that of needling the extensor muscle group and conventional acupuncture, providing certain evidence and guidance for the selection of moxibustion sites in clinical practice.
Detailed description
105 patients with upper limb dysfunction after stroke were selected according to the inclusion criteria and randomly divided into an extensor treatment group, a flexor treatment group, and a control group of 35 cases each. The patients in the extensor treatment group were treated with routine rehabilitation training+routine acupuncture and moxibustion+millifire needle acupuncture for the extensor muscle group (triceps brachii, forearm extensor muscle group), the patients in the flexor treatment group were treated with routine rehabilitation training+routine acupuncture and moxibustion+millifire needle acupuncture for the flexor muscle group (biceps brachii, forearm flexor muscle group), and the patients in the control group were treated with routine rehabilitation training+routine acupuncture and moxibustion+routine millifire needle acupuncture. The treatment was administered once every other day with a moxibustion needle for a total of 4 weeks. Observe the upper limb movement trajectory, surface electromyographic signals (sEMG) of extensor and flexor muscle groups, changes in MAS scale scores, and FMA-UE scores of two groups of patients under specific tasks detected by a three-dimensional motion capture system before, after one treatment, and after 4 weeks of treatment. Calculate joint angles and motion distances through spatial coordinates, and apply RMS MF、CC、 Coherence analysis quantifies muscle strength, muscle tension, fatigue, and coordination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flexed muscle Milli-fire needle | Experimental | Other: conventional rehabilitation training, Other: conventional acupuncture, Other: Acupuncture with the milli-needle fire-puncture on flexor muscle groupsPatients in the flexor treatment group received conventional rehabilitation training, conventional acupuncture, and moxibustion with fine fire needles on the flexor muscle groups (biceps brachii and forearm flexor muscle groups).The Milli-fire needle treatment was administered every other day for a total of 4 weeks. |
| Extensor muscle Milli-fire needle | Experimental | Other: conventional rehabilitation training, Other: conventional acupuncture, Other: Acupuncture with the milli-needle fire-puncture on extensor muscle groupsThe patients in the extensor muscle treatment group received conventional rehabilitation training , conventional acupuncture and moxibustion with Milli-fire needle on the extensor muscle groups (triceps brachii, forearm extensor muscles).The Milli-fire needle treatment was administered every other day for a total of 4 weeks. |
| Control group | Active comparator | Other: conventional rehabilitation training, Other: conventional acupuncture, Other: Conventional needle puncture with a fire needlePatients in the control group received conventional rehabilitation training, conventional acupuncture, and conventional moxibustion with Milli-fire needle.The acupuncture points for fire needle puncture are commonly used ones on the upper limbs.The Milli-fire needle treatment was administered every other day for a total of 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meet the diagnostic criteria.
- The patient had a first stroke and the course of disease was 15 days to 12 months.
- With unilateral disease， the muscular tone assessed by the modified Ashworth scale of upper limb was Ⅰ/Ⅰ+/Ⅱ/Ⅲ level ，Brunnstrom stage in upper limb was Ⅲ/Ⅳ/Ⅴ， Upper limb muscle strength is greater than or equal to grade 2.
- Age 18-70 years old.
- Have not taken Chinese or Western medicine sedatives muscle relaxants or any drugs that have an impact on muscle tone recently.
Key exclusion criteria (6 listed)
- Bilateral disease.
- History of serious injury or disease of other upper limb nerves muscles or bones.
- Patients with severe cervical spondylosis and hypertension.
- Patients with audiovisual abnormalities severe cognitive impairment and mental diseases who cannot cooperate with the examination.
- Patients with tumor and severe malnutrition.
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 |
|---|---|---|
| conventional rehabilitation trainingThe rehabilitation training is designed based on the specific functional conditions of the patient's limbs. The specific training methods include proper limb positioning, exercise therapy such as passive movement, anti-spasticity training, scapular girdle muscle training, joint extension training, forearm pronation and supination training, occupational therapy, joint movement training, roller treatment, and fine motor skill training, etc. The treatment is conducted once a day and five times a week. The treatment lasts for 4 consecutive weeks. | Other | Control group, Extensor muscle Milli-fire needle, Flexed muscle Milli-fire needle |
| conventional acupunctureConventional acupuncture treatment involves needling at acupoints on the upper limbs of patients to improve their upper limb function. The treatment is administered once a day, five times a week, for a continuous period of four weeks. | Other | Control group, Extensor muscle Milli-fire needle, Flexed muscle Milli-fire needle |
| Acupuncture with the milli-needle fire-puncture on flexor muscle groupsThe acupuncture points of the milli-needle fire-puncture device are located in the flexor muscle groups of the upper limbs, including the biceps brachii and the flexor muscle group of the forearm. | Other | Flexed muscle Milli-fire needle |
| Acupuncture with the milli-needle fire-puncture on extensor muscle groupsThe acupuncture points for the milli-needle fire-puncture device are located in the extensor muscle groups of the upper limbs, including the triceps brachii and the extensor muscles of the forearm. | Other | Extensor muscle Milli-fire needle |
| Conventional needle puncture with a fire needleThe acupuncture points for milli-needle fire-puncture are commonly used ones on the upper limbs. | Other | Control group |
Primary outcome
Root mean square(RMS) of surface electromyography(sEMG）
Time frame: 4 weeks
Using sEMG the EMG of the upper limb muscles is collected including RMS
9 secondary outcomes
RMS of sEMG
Time frame: first day
Mean Frequency (MF)of SEMG
Time frame: first day
Joint angle
Time frame: first day
Motion distance
Time frame: first day
Joint angle
Time frame: 4 weeks
Motion distance
Time frame: 4 weeks
Fugl-Meyer Assessment Upper Extremity Scale(FMA-UE)
Time frame: 4 weeks
Modified Ashworth Scale(MAS)
Time frame: 4 weeks
Mean Frequency (MF)of SEMG
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Yes. The original data will be released on 2026.12.30,and the method will be dislosed through the publishde papers.
Related trials for Cerebral Infarction
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional rehabilitation training, conventional acupuncture and Acupuncture with the milli-needle fire-puncture on flexor muscle groups in people with Cerebral Infarction, run by Qilu Hospital of Shandong University 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Root mean square(RMS) of surface electromyography(sEMG） (time frame: 4 weeks). 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 24 Aug 2025.