Stroke SequelaeNCT06208059

Electroacupuncture of Scalp Motor Area to Improve Post-Stroke Wrist Dyskinesia

A study testing manual acupuncture and electroacupuncture in people with Stroke Sequelae and Movement Disorders, run by Heilongjiang University of Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Stroke Sequelae, Movement Disorders
What is being tested?: manual acupuncture and electroacupuncture
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteChina
Study dates: 1 Jul 2021to 1 Jan 2023
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients with upper limb movement disorders who meet the diagnostic criteria for stroke;
40 years old ≤ age ≤ 75 years old, gender is not limited;
head MRI or CT scanning found responsible lesions;
first onset of the disease, disease duration of 2 weeks to 6 months, stable condition, stable vital signs, conscious without unconsciousness;
upper limb muscle strength on the affected side ≥ grade 3, wrist dorsiflexion muscle strength ≥ grade 2, wrist flexion muscle strength ≥ grade 2;
no serious cardiac, pulmonary, or renal impairment;
voluntarily participate in this study and sign the informed consent form.

Who cannot join

a previous history of stroke or other brain disease;
with severe mental retardation and/or severe aphasia that interferes with communication;
with severe cardiac, pulmonary, and renal impairment in an unstable condition;
inability to autonomously perform wrist flexion and extension movements on the hemiplegic side;
neurological or musculoskeletal diseases affecting the recovery of limb function before the onset of the disease, with pre-existing abnormalities in bilateral wrist movements;
allergy to adhesive tape, solid gel, etc.; bleeding tendency, acute suppurative inflammation, combined ulcers, infections, scars and tumors at acupuncture points and nearby areas; installation of pacemakers;
transient ischemic attack, rebleeding after infarction, bilateral cerebral infarction, brain stem infarction, excessive cerebral hemorrhage or cranial defect;
history of needle fainting or fear of needling.

Trial locations and contacts

1 site in 1 country.

China1 site

The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150040

Other trials in China

About this study

Official title: Electroacupuncture of Scalp Motor Area to Improve Post-Stroke Wrist Dyskinesia and Its Effect on Muscle Function: a Single-Blind, Randomized, Controlled Clinical Trial

The goal of this clinical trial is to compare the clinical efficacy of electroacupuncture and manual acupuncture in stimulating the scalp motor area for treating post-stroke wrist dyskinesia and its influence on the function of wrist movement-related active muscles. The main question it aims to answer is: which method of stimulating the scalp motor area is more effective in the recovery of wrist motor function after stroke? Participants will be given routine Western medicine treatment and acupuncture treatment on the hemiplegic side. In the manual acupuncture group, participants will be needled in the scalp motor area on the lesion side. The same acupoint was selected as the manual acupuncture group in the electroacupuncture group. The score of Chinese Stroke Scale (CSS), the score of the upper limb of the Barthel Index (BI), the active range of motion (AROM) of wrist joint, and the surface electromyography (sEMG) was used to measure the root mean square (RMS) of extensor carpi radialis longus, extensor digitorum, flexor carpi radialis and flexor carpi ulnaris on the hemiplegic side of the patients before and after the 3-week treatment period, respectively compare the clinical efficacy of the two groups.

Read the detailed description

Participants will be randomly divided into an electroacupuncture group and a manual acupuncture group according to a ratio of 1: 1. In the manual acupuncture group, participants will be needled in the scalp motor area on the lesion side and left in place for 30 minutes after obtaining qi. During needle retention, the needles will be intermittently twisted for 2min twice, with a frequency of about 200 r/min. The same acupoint was selected as the manual acupuncture group in the electroacupuncture group. After obtaining qi, electroacupuncture stimulation will be applied using a continuous wave at a frequency of 2 Hz. The stimulation intensity will be adjusted based on the patient's tolerance, and each treatment will be lasted for 30 minutes. Participants patients in both groups will be treated once a day and rest for one day after six consecutive days of treatment, for a total of three weeks.

Conditions: Stroke Sequelae, Movement Disorders
Being tested: manual acupuncture, electroacupuncture
Medical subject headings: Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

manual acupunctureOther
In manual acupuncture, the scalp motor area on the lesion side will be needled and left in place for 30 minutes after obtaining qi. During the needle retention, the needles will be twisted intermittently for 2 minutes twice, at a frequency of approximately 200 r/min.
electroacupunctureOther
In electroacupuncture, the scalp motor area will be needled, and after obtaining qi, the treatment will involve applying electroacupuncture stimulation using a continuous wave with a frequency of 2 Hz. The intensity of the stimulation will be adjusted based on the patient's tolerance, and each treatment session will last for 30 minutes.

Study groups in NCT06208059
Study group	Role	What they receive
manual acupuncture group	Active comparator	In the manual acupuncture group, participants will be needled in the scalp motor area on the lesion side and left in place for 30 minutes after obtaining qi. During needle retention, the needles will be intermittently twisted for 2min twice, with a frequency of about 200 r/min. Participants will receive treatment once daily, with six consecutive days of treatment followed by one day of rest each week, for three weeks. Receives: Other: manual acupuncture
electroacupuncture group	Experimental	The same acupoint was selected as the manual acupuncture group in the electroacupuncture group. After obtaining qi, electroacupuncture stimulation will be applied using a continuous wave at a frequency of 2 Hz. The stimulation intensity will be adjusted based on the patient's tolerance, and each treatment will be lasted for 30 minutes. Participants will receive treatment once daily, with six consecutive days of treatment followed by one day of rest each week, for three weeks. Receives: Other: electroacupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

Chinese Stroke Scale
CSS comprehensively evaluated the neurological impairment of stroke patients from eight dimensions: level of consciousness, horizontal gaze, facial paralysis, speech, shoulder, hand, lower extremities and walking ability. the score ranged from 0 to 45. The higher the score, the more serious the neurological impairment.
Measured: 1 day before treatment and at the end of 3 weeks of treatment

Secondary outcomes (3)

the Barthel Index of ADL
BI (The Barthel Index of ADL) is a recognized and valid index for assessing the ability of activities of daily living, which includes 10 items such as dressing, grooming, eating, toileting, bowel control, bathing, transferring, and so on. In this study, we mainly observe the upper limb-related parts of the BI score (grooming, dressing, eating, bathing, and toileting), with higher scores representing better functional recovery of the upper limbs.
Measured: 1 day before treatment and at the end of 3 weeks of treatment
Active Range of Motion
The normal range of motion is 0° to 70° for wrist dorsiflexion and 0° to 90° for wrist flexion. In this study, the electronic joint angle ruler will be used for measurement, and the value can be displayed to 1 decimal place. During measurement, the patient sits and relaxes the affected forearm on the table, the axis of the electronic joint angle ruler is placed at the ulnar styloid, the fixed arm is parallel to the ulna, and the mobile arm is parallel to the fifth metacarpal bone. The patient will be instructed to actively extend the wrist dorsally, flex the wrist palmarly and measure the angle of maximum activity, the greater the AROM the better the recovery of wrist joint motor function.
Measured: 1 day before treatment and at the end of 3 weeks of treatment
Root Mean Square
RMS is one of the main characteristic values of surface electromyography, which is positively correlated with muscle strength, and the higher the RMS, the stronger the muscle strength. FlexComp Infiniti SA7550 10-channel sEMG (Thought Technology Ltd, Canada) will be used to measure the RMS values of ECRL (Extensor Carpi Radialis Longus) and ED (Extensor Digitorum) in active wrist dorsiflexion, and the RMS values of FCR (Flexor Carpi Radialis) and FCU (Flexor Carpi Ulnaris) on the hemiplegic side of the patient in active wrist flexion.
Measured: 1 day before treatment and at the end of 3 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20211 Jan 2023

First posted17 Jan 2024
Study start1 Jul 2021
Primary completion31 Oct 2022
Study completion1 Jan 2023

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: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06208059
Sponsor's protocol ID: V1.1
Status last verified: Jan 2024
First submitted: 5 Jan 2024
Last updated: 17 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data sharing will be based on actual situation in future.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Psychometric Study of the Spanish Version of Two Upper Limb Assessment Scales in Chronic Stroke
Chronic Stroke
Not yet recruitingPhase 2
ALT001 in Patients With Ischemic Stroke in the Sequelae Stage
Ischemic Stroke in the Sequelae Stage
Not yet recruiting
Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks
Stroke Sequelae, Deglutition Disorders
Active, not recruitingObservational study
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
Spasticity as Sequela of Stroke
Recruiting
TDCS to Improve Post-Stroke Cognitive Impairment
Stroke, Stroke Sequelae

All Stroke Sequelae trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Electroacupuncture of Scalp Motor Area to Improve Post-Stroke Wrist Dyskinesia and Its Effect on Muscle Function: a Single-Blind, Randomized, Controlled Clinical Trial
ClinicalTrials.gov ID: NCT06208059
Acronym / sponsor ID: V1.1
Conditions: Stroke Sequelae, Movement Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Heilongjiang University of Chinese MedicineUniversity, hospital or other
Study start: 1 Jul 2021 (actual)
Primary completion: 31 Oct 2022 (actual)
Study completion: 1 Jan 2023 (actual)
First posted: 17 Jan 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
manual acupuncture group	Active comparator	Other: manual acupunctureIn the manual acupuncture group, participants will be needled in the scalp motor area on the lesion side and left in place for 30 minutes after obtaining qi. During needle retention, the needles will be intermittently twisted for 2min twice, with a frequency of about 200 r/min. Participants will receive treatment once daily, with six consecutive days of treatment followed by one day of rest each week, for three weeks.
electroacupuncture group	Experimental	Other: electroacupunctureThe same acupoint was selected as the manual acupuncture group in the electroacupuncture group. After obtaining qi, electroacupuncture stimulation will be applied using a continuous wave at a frequency of 2 Hz. The stimulation intensity will be adjusted based on the patient's tolerance, and each treatment will be lasted for 30 minutes. Participants will receive treatment once daily, with six consecutive days of treatment followed by one day of rest each week, for three weeks.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

patients with upper limb movement disorders who meet the diagnostic criteria for stroke;
40 years old ≤ age ≤ 75 years old, gender is not limited;
head MRI or CT scanning found responsible lesions;
first onset of the disease, disease duration of 2 weeks to 6 months, stable condition, stable vital signs, conscious without unconsciousness;
upper limb muscle strength on the affected side ≥ grade 3, wrist dorsiflexion muscle strength ≥ grade 2, wrist flexion muscle strength ≥ grade 2;

Key exclusion criteria (8 listed)

a previous history of stroke or other brain disease;
with severe mental retardation and/or severe aphasia that interferes with communication;
with severe cardiac, pulmonary, and renal impairment in an unstable condition;
inability to autonomously perform wrist flexion and extension movements on the hemiplegic side;
neurological or musculoskeletal diseases affecting the recovery of limb function before the onset of the disease, with pre-existing abnormalities in bilateral wrist movements;

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
manual acupunctureIn manual acupuncture, the scalp motor area on the lesion side will be needled and left in place for 30 minutes after obtaining qi. During the needle retention, the needles will be twisted intermittently for 2 minutes twice, at a frequency of approximately 200 r/min.	Other	manual acupuncture group
electroacupunctureIn electroacupuncture, the scalp motor area will be needled, and after obtaining qi, the treatment will involve applying electroacupuncture stimulation using a continuous wave with a frequency of 2 Hz. The intensity of the stimulation will be adjusted based on the patient's tolerance, and each treatment session will last for 30 minutes.	Other	electroacupuncture group

Primary outcome

Chinese Stroke Scale
Time frame: 1 day before treatment and at the end of 3 weeks of treatment
CSS comprehensively evaluated the neurological impairment of stroke patients from eight dimensions: level of consciousness, horizontal gaze, facial paralysis, speech, shoulder, hand, lower extremities and walking ability. the score ranged from 0 to 45. The higher the score, the more serious the neurological impairment.

3 secondary outcomes

the Barthel Index of ADL
Time frame: 1 day before treatment and at the end of 3 weeks of treatment
Active Range of Motion
Time frame: 1 day before treatment and at the end of 3 weeks of treatment
Root Mean Square
Time frame: 1 day before treatment and at the end of 3 weeks of treatment

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 17 Jan 2024.
Individual participant dataSharing planned: No. Data sharing will be based on actual situation in future.

Related trials for Stroke Sequelae

Enrolling by invitationObservational study
Psychometric Study of the Spanish Version of Two Upper Limb Assessment Scales in Chronic Stroke
Chronic Stroke
Not yet recruitingPhase 2
ALT001 in Patients With Ischemic Stroke in the Sequelae Stage
Ischemic Stroke in the Sequelae Stage
Not yet recruiting
Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks
Stroke Sequelae, Deglutition Disorders
Active, not recruitingObservational study
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
Spasticity as Sequela of Stroke
Recruiting
TDCS to Improve Post-Stroke Cognitive Impairment
Stroke, Stroke Sequelae

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.

Dongyan Wang, PhD study director

The Second Affiliated Hospital of 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 study testing manual acupuncture and electroacupuncture in people with Stroke Sequelae and Movement Disorders, run by Heilongjiang University of 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 8 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 17 Jan 2024. 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?

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?

Chinese Stroke Scale (time frame: 1 day before treatment and at the end of 3 weeks of treatment). 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 NCT06208059.

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 17 Jan 2024.