Stroke SequelaeEarly Phase 1NCT06061731
Low-frequency Electrical Stimulation of Acupuncture Points
A Early Phase 1 study testing low-frequency acupoint electrical stimulation in people with Stroke Sequelae, run by Xue Xia at 1 site in China.
Trial summary
Abstract: Objective: To examine the effect of low-frequency acupoint electrical stimulation (LFES) on the surface electromyographic (sEMG) signals of the thumb-to-finger movement muscles in stroke patients, and to evaluate the clinical efficacy of LFES on hand function recovery after stroke. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- low-frequency acupoint electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 12 Dec 2022
- Phase
- Early Phase 1
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ①Diagnostic criteria for upper extremity motor dysfunction after stroke. ②Age 35-75 years and duration of illness is 2 weeks to 3 months. ③ Impaired hand function with Lovett classification ≥ grade 2 and MAS ≤ grade 2. ④No organ dysfunction such as heart, liver, lung, kidney or blood circulation dysfunction. ⑤Clear consciousness, no major impairment in intelligence, hearing or speech, and stable condition. ⑥Patients voluntarily participated in this subject trial and signed the informed consent form.
Who cannot join
- Presence of neurological or musculoskeletal disorders affecting functional recovery prior to the onset of the disease. ②Brainstem infarction, bilateral cerebral infarction or transient ischemic attack.
Trial locations and contacts
1 site in 1 country.
China1 site
Low-Frequency Acupoint Electrical Stimulation
Harbin, Heilongjiang, 150040
About this study
Official title: Master's Degree Candidate in Acupuncture and Tuina
Abstract:
Objective: To examine the effect of low-frequency acupoint electrical stimulation (LFES) on the surface electromyographic (sEMG) signals of the thumb-to-finger movement muscles in stroke patients, and to evaluate the clinical efficacy of LFES on hand function recovery after stroke.
Read the detailed description
Methods: Sixty patients who met the inclusion criteria were randomly assigned to a LFES group or an electroacupuncture (EA) group, with 30 patients in each group. Both groups received conventional treatment, and the EA group was treated with acupoints from the book of Acupuncture and Moxibustion, while the LFES group was treated with acupoints from a previous study. The sEMG characteristic values (MAX and RMS), Chinese Stroke Clinical Neurological Deficit Scale (CSS), Brunnstrom Motor Function Evaluation, Modified Ashworth Scale (MAS), Lindmark Hand Function Score and Lovett Muscle Strength Classification were measured before and after treatment.
- Conditions
- Stroke Sequelae
- Being tested
- low-frequency acupoint electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-frequency acupoint electrical stimulationDrug
Also called electroacupuncture
In order to determine the efficacy of low-frequency acupoint electrical stimulation and electroacupuncture to improve thumb to finger action after stroke
| Study group | Role | What they receive |
|---|---|---|
| Low frequency group treatment | Active comparator | Low frequency group treatment: The treatment frequency is selected as 50Hz, pulse width 0.3ms, waveform is intermittent waveform, stimulation intensity is tolerated by the patient, the instrument program is set to stimulate the first group of acupoints → second group → first group → third group, forming a set of programmed movements, cyclic operation, appearing alternate movements of flexor and extensor muscles, namely: wrist dorsal extension, five-finger extension → five-finger flexion → wrist dorsal extension, five-finger extension → thumb-index finger pair pinching, simulating fine movements Grasp of the hand, thumb-index finger pair pinch. The treatment course was the same as that of the electroacupuncture group. Receives: Drug: low-frequency acupoint electrical stimulation |
| Electroacupuncture group treatment | No intervention | Electroacupuncture group treatment: After the above acupuncture to deqi, choose KWD-808 Ⅰ type Indy brand pulse acupuncture treatment instrument, the waveform is continuous wave, the stimulation frequency is 2Hz, the intensity to be tolerated by the patient. There should be muscle contraction at the acupuncture site during electroacupuncture treatment. The treatment time should be 30 minutes each time, once a day, 6 days a week with 1 day off, for a total of 3 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sEMG eigenvalues
sEMG eigenvalues: two main aspects, maximum value (MAX), and root mean square value (RMS). MAX reflects the maximum contraction strength of the measured muscle. RMS is the root mean square of the EMG transient amplitude over time, which reflects the average change in EMG signal and is therefore used as an evaluation of muscle contraction performance.
Measured: Three weeks
Secondary outcomes (5)
CSS score
In this study, the upper extremity and hand muscle strength and motor function were assessed to evaluate the efficacy of patients, and the consciousness, upper extremity and hand evaluation components were selected for assessment. The lower the CSS score, the better the improvement in neurological deficits.
Measured: Three weeks
Brunnstrom's method of motor function evaluation
Grade I: no movement; Grade II: only weak flexion and extension; Grade III: hook grasp, but not finger extension; Grade IV: able to pinch laterally and thumb release, fingers can be extended semi-randomly and to a small extent; Grade V: can ball and column grasp, fingers extend simultaneously, but not individually; Grade VI: all grasps can be completed, but the speed and accuracy are worse than the non-involved side.
Measured: Three weeks
Modified Ashworth Scale
no increase in muscle tone; Grade 1: mildly increased muscle tone, with minor resistance felt during passive flexion/extension to the maximum extent in grasping movements; Grade 1+: slightly increased muscle tone, with minor resistance felt during flexion/extension to more than 1/2 range in grasping movements; Grade 2: heavy resistance felt in most ranges of motion, but passive activities can be performed Grade 3: muscle tone is significantly elevated and passive activities are not easily performed; Grade 4: the affected portion of the limb exhibits tonic extension or flexion.
Measured: Three weeks
Lindmark hand function score
1 point: gripping action can be completed, but can not resist tiny resistance; 2 points: can hold an object for 5s, but can not resist medium resistance, or grip is not standard, uncoordinated; 3 points: grip is normal, can hold an object against larger resistance for 5s, and can release the hand like normal people, the total score is 24 points, the higher the score, the The higher the score, the better the hand function.
Measured: Three weeks
Lovett muscle strength classification
Grade 0: complete muscle paralysis, palpation muscle completely no contraction; Grade I: slight muscle contraction, but can not cause joint movement; Grade II: can drive the joint horizontal activity, but can not fight gravity; Grade III: can fight gravity to do active joint activity, but can not fight resistance; Grade IV: can fight a larger resistance, but weaker than normal; Grade V: normal muscle strength .
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Jan 2022
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- low-frequency acupoint electrical stimulation
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xue Xia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xue Xia, Heilongjiang University of Chinese Medicine
- Investigators
- Xue Xia, Study chair, Heilongjiang University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061731
- Sponsor's protocol ID
- 12230000414003578W
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master's Degree Candidate in Acupuncture and Tuina
- ClinicalTrials.gov ID
- NCT06061731
- Acronym / sponsor ID
- 12230000414003578W
- Conditions
- Stroke Sequelae
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Xue XiaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 29 Sep 2023 (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.
Abstract:
Objective: To examine the effect of low-frequency acupoint electrical stimulation (LFES) on the surface electromyographic (sEMG) signals of the thumb-to-finger movement muscles in stroke patients, and to evaluate the clinical efficacy of LFES on hand function recovery after stroke.
Detailed description
Methods: Sixty patients who met the inclusion criteria were randomly assigned to a LFES group or an electroacupuncture (EA) group, with 30 patients in each group. Both groups received conventional treatment, and the EA group was treated with acupoints from the book of Acupuncture and Moxibustion, while the LFES group was treated with acupoints from a previous study. The sEMG characteristic values (MAX and RMS), Chinese Stroke Clinical Neurological Deficit Scale (CSS), Brunnstrom Motor Function Evaluation, Modified Ashworth Scale (MAS), Lindmark Hand Function Score and Lovett Muscle Strength Classification were measured before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- low-frequency acupoint electrical stimulation
| Arm | Type | Receives |
|---|---|---|
| Low frequency group treatment | Active comparator | Drug: low-frequency acupoint electrical stimulationLow frequency group treatment: The treatment frequency is selected as 50Hz, pulse width 0.3ms, waveform is intermittent waveform, stimulation intensity is tolerated by the patient, the instrument program is set to stimulate the first group of acupoints → second group → first group → third group, forming a set of programmed movements, cyclic operation, appearing alternate movements of flexor and extensor muscles, namely: wrist dorsal extension, five-finger extension → five-finger flexion → wrist dorsal extension, five-finger extension → thumb-index finger pair pinching, simulating fine movements Grasp of the hand, thumb-index finger pair pinch. The treatment course was the same as that of the electroacupuncture group. |
| Electroacupuncture group treatment | No intervention | –Electroacupuncture group treatment: After the above acupuncture to deqi, choose KWD-808 Ⅰ type Indy brand pulse acupuncture treatment instrument, the waveform is continuous wave, the stimulation frequency is 2Hz, the intensity to be tolerated by the patient. There should be muscle contraction at the acupuncture site during electroacupuncture treatment. The treatment time should be 30 minutes each time, once a day, 6 days a week with 1 day off, for a total of 3 weeks. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ①Diagnostic criteria for upper extremity motor dysfunction after stroke. ②Age 35-75 years and duration of illness is 2 weeks to 3 months. ③ Impaired hand function with Lovett classification ≥ grade 2 and MAS ≤ grade 2. ④No organ dysfunction such as heart, liver, lung, kidney or blood circulation dysfunction. ⑤Clear consciousness, no major impairment in intelligence, hearing or speech, and stable condition. ⑥Patients voluntarily participated in this subject trial and signed the informed consent form.
Key exclusion criteria (1 listed)
- Presence of neurological or musculoskeletal disorders affecting functional recovery prior to the onset of the disease. ②Brainstem infarction, bilateral cerebral infarction or transient ischemic attack.
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 |
|---|---|---|
| low-frequency acupoint electrical stimulationAlso: electroacupunctureIn order to determine the efficacy of low-frequency acupoint electrical stimulation and electroacupuncture to improve thumb to finger action after stroke | Drug | Low frequency group treatment |
Primary outcome
sEMG eigenvalues
Time frame: Three weeks
sEMG eigenvalues: two main aspects, maximum value (MAX), and root mean square value (RMS). MAX reflects the maximum contraction strength of the measured muscle. RMS is the root mean square of the EMG transient amplitude over time, which reflects the average change in EMG signal and is therefore used as an evaluation of muscle contraction performance.
5 secondary outcomes
CSS score
Time frame: Three weeks
Brunnstrom's method of motor function evaluation
Time frame: Three weeks
Modified Ashworth Scale
Time frame: Three weeks
Lindmark hand function score
Time frame: Three weeks
Lovett muscle strength classification
Time frame: Three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- 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.
Xue Xia study chair
Heilongjiang University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing low-frequency acupoint electrical stimulation in people with Stroke Sequelae, run by Xue Xia 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Sep 2023. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
sEMG eigenvalues (time frame: Three 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 29 Sep 2023.