Limb Dysfunction in Ischemic Stroke Patients at High-Altitude RegionsNCT07074600
Clinical Efficacy of Electroacupuncture Therapy on Limb Dysfunction in Ischemic Stroke Patients at High-Altitude Regions: A Multi-center Randomized Double-blind Controlled Trial
A study testing Electroacupuncture Therapy in people with Limb Dysfunction in Ischemic Stroke Patients at High-Altitude Regions, run by Kaiyang Zheng.
Trial summary
The purpose of this clinical trial is to investigate the efficacy of electroacupuncture therapy for limb dysfunction in ischemic stroke patients residing at high-altitude regions. This study aims to address the following research questions: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Limb Dysfunction in Ischemic Stroke Patients at High-Altitude Regions
- What is being tested?
- Electroacupuncture Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 15 Feb 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Meeting diagnostic criteria for ischemic stroke ; (2) Aged 18-75 years ; (3) Total stroke episodes < 3 ; (4) Current stroke with disease course of 2 weeks to 3 months ; (5) Severity of limb motor impairment assessed by the National Institutes of Health Stroke Scale (NIHSS) score .
Who cannot join
- (1) Patients with transient ischemic attack (TIA), cerebral hemorrhage, or reversible ischemic neurological deficit (RIND); (2) Patients with intracranial space-occupying lesions; (3) Patients with severe aphasia or other complications impairing scale assessment compliance; (4) Pregnant or lactating women, or those planning pregnancy; (5) Patients with acupuncture contraindications.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this clinical trial is to investigate the efficacy of electroacupuncture therapy for limb dysfunction in ischemic stroke patients residing at high-altitude regions. This study aims to address the following research questions: 1. Whether electroacupuncture therapy demonstrates clinical effectiveness in managing limb dysfunction among ischemic stroke patients in high-altitude regions. 2. Whether electroacupuncture therapy maintains an acceptable safety profile in this specific population.
Researchers will conduct a comparative analysis between the active electroacupuncture intervention group and a sham-electroacupuncture control group to evaluate therapeutic efficacy. Participants will: 1. Undergo daily electroacupuncture treatment sessions for a standardized 14-day therapeutic course. 2. Complete comprehensive functional assessments and neurological evaluations at baseline and post-intervention timepoints.
- Being tested
- Electroacupuncture Therapy, Sham electroacupuncture intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture TherapyDevice
Also called Electroacupuncture
Participants in the experimental group will receive daily electroacupuncture therapy over a standardized 14-day therapeutic course. Comprehensive functional and neurological assessments will be conducted at pre-intervention (baseline) and post-intervention timepoints. Acupoint selection will target anatomical domains spanning the cranial, upper limb, and lower limb regions.
Sham electroacupuncture interventionDevice
Also called Sham electroacupuncture
Participants in the control group will receive daily sham electroacupuncture therapy over a standardized 14-day therapeutic course. Comprehensive functional and neurological assessments will be conducted at pre-intervention (baseline) and post-intervention timepoints. Sham electroacupuncture procedures will target non-acupoint locations outside recognized cranial, upper limb, and lower limb anatomical domains.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture Therapy | Experimental | Participants will be randomized into an experimental group and a control group. The experimental group will receive daily electroacupuncture therapy for a standardized 14-day course, with comprehensive functional and neurological assessments conducted at pre-intervention (baseline) and post-intervention timepoints. The control group will undergo daily sham acupuncture under identical conditions, including matching treatment duration and assessment schedules. Electroacupuncture administration will target acupoints spanning cranial, upper limb, and lower limb anatomical domains. Receives: Device: Electroacupuncture Therapy |
| Sham electroacupuncture intervention | Experimental | Participants in the control group will receive daily sham electroacupuncture therapy over a standardized 14-day therapeutic course. Comprehensive functional and neurological assessments will be conducted at pre-intervention (baseline) and post-intervention timepoints. Sham electroacupuncture procedures will target non-acupoint locations outside recognized cranial, upper limb, and lower limb anatomical domains. Receives: Device: Sham electroacupuncture intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Scale (FMA)
Measured: "Baseline"，"Day 7"，"Day 14"
Fugl-Meyer Assessment Scale (FMA)
Assessments were conducted at baseline (pre-intervention), day 7 of treatment, and post-intervention. The evaluation comprises 33 items for upper extremity motor function and 17 items for lower extremity motor function. Each item is scored 2 points for full completion, 1 point for partial completion, and 0 points for inability to complete. The total score ranges from 0 to 66 for upper extremities and 0 to 34 for lower extremities, with higher scores indicating better motor function.
Measured: "Baseline"，"Day 7"，"Day 14"
Secondary outcomes (1)
Activities of Daily Living Assessment Scale (ADL) Score
Assessments were conducted at baseline (pre-intervention), day 10 of treatment, and post-intervention. The ADL assessment scale is primarily used to evaluate the activities of daily living and functional status in stroke patients, encompassing 11 items related to 10 fundamental aspects of self-care and mobility. Each item is scored on a scale of 0 to 15 points, with the sum of all items constituting the ADL score. Higher scores indicate better daily living ability.
Measured: "Baseline"，"Day 7"，"Day 14"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb Dysfunction in Ischemic Stroke Patients at High-Altitude RegionsStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiyang Zheng
- Sponsor type
- University, hospital or other
- Collaborators
- Qinghai People's Hospital
- Responsible party
- Sponsor-investigator, Kaiyang Zheng, Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074600
- Sponsor's protocol ID
- PJ202501-23
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Jul 2025
- 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 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Electroacupuncture Therapy on Limb Dysfunction in Ischemic Stroke Patients at High-Altitude Regions: A Multi-center Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07074600
- Acronym / sponsor ID
- PJ202501-23
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaiyang ZhengUniversity, hospital or other
- Collaborators
- Qinghai People's Hospital
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 20 Jul 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.
The purpose of this clinical trial is to investigate the efficacy of electroacupuncture therapy for limb dysfunction in ischemic stroke patients residing at high-altitude regions. This study aims to address the following research questions: 1. Whether electroacupuncture therapy demonstrates clinical effectiveness in managing limb dysfunction among ischemic stroke patients in high-altitude regions. 2. Whether electroacupuncture therapy maintains an acceptable safety profile in this specific population.
Researchers will conduct a comparative analysis between the active electroacupuncture intervention group and a sham-electroacupuncture control group to evaluate therapeutic efficacy. Participants will: 1. Undergo daily electroacupuncture treatment sessions for a standardized 14-day therapeutic course. 2. Complete comprehensive functional assessments and neurological evaluations at baseline and post-intervention timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture Therapy | Experimental | Device: Electroacupuncture TherapyParticipants will be randomized into an experimental group and a control group. The experimental group will receive daily electroacupuncture therapy for a standardized 14-day course, with comprehensive functional and neurological assessments conducted at pre-intervention (baseline) and post-intervention timepoints. The control group will undergo daily sham acupuncture under identical conditions, including matching treatment duration and assessment schedules. Electroacupuncture administration will target acupoints spanning cranial, upper limb, and lower limb anatomical domains. |
| Sham electroacupuncture intervention | Experimental | Device: Sham electroacupuncture interventionParticipants in the control group will receive daily sham electroacupuncture therapy over a standardized 14-day therapeutic course. Comprehensive functional and neurological assessments will be conducted at pre-intervention (baseline) and post-intervention timepoints. Sham electroacupuncture procedures will target non-acupoint locations outside recognized cranial, upper limb, and lower limb anatomical domains. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Meeting diagnostic criteria for ischemic stroke ; (2) Aged 18-75 years ; (3) Total stroke episodes < 3 ; (4) Current stroke with disease course of 2 weeks to 3 months ; (5) Severity of limb motor impairment assessed by the National Institutes of Health Stroke Scale (NIHSS) score .
Key exclusion criteria (1 listed)
- (1) Patients with transient ischemic attack (TIA), cerebral hemorrhage, or reversible ischemic neurological deficit (RIND); (2) Patients with intracranial space-occupying lesions; (3) Patients with severe aphasia or other complications impairing scale assessment compliance; (4) Pregnant or lactating women, or those planning pregnancy; (5) Patients with acupuncture contraindications.
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 |
|---|---|---|
| Electroacupuncture TherapyAlso: ElectroacupunctureParticipants in the experimental group will receive daily electroacupuncture therapy over a standardized 14-day therapeutic course. Comprehensive functional and neurological assessments will be conducted at pre-intervention (baseline) and post-intervention timepoints. Acupoint selection will target anatomical domains spanning the cranial, upper limb, and lower limb regions. | Device | Electroacupuncture Therapy |
| Sham electroacupuncture interventionAlso: Sham electroacupunctureParticipants in the control group will receive daily sham electroacupuncture therapy over a standardized 14-day therapeutic course. Comprehensive functional and neurological assessments will be conducted at pre-intervention (baseline) and post-intervention timepoints. Sham electroacupuncture procedures will target non-acupoint locations outside recognized cranial, upper limb, and lower limb anatomical domains. | Device | Sham electroacupuncture intervention |
Primary outcome
Fugl-Meyer Assessment Scale (FMA)
Time frame: "Baseline"，"Day 7"，"Day 14"
Fugl-Meyer Assessment Scale (FMA)
Time frame: "Baseline"，"Day 7"，"Day 14"
Assessments were conducted at baseline (pre-intervention), day 7 of treatment, and post-intervention. The evaluation comprises 33 items for upper extremity motor function and 17 items for lower extremity motor function. Each item is scored 2 points for full completion, 1 point for partial completion, and 0 points for inability to complete. The total score ranges from 0 to 66 for upper extremities and 0 to 34 for lower extremities, with higher scores indicating better motor function.
1 secondary outcome
Activities of Daily Living Assessment Scale (ADL) Score
Time frame: "Baseline"，"Day 7"，"Day 14"
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 20 Jul 2025.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture Therapy in people with Limb Dysfunction in Ischemic Stroke Patients at High-Altitude Regions, run by Kaiyang Zheng.
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: opening soon, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact kaiyang zheng (15079603010, zky20000623@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment Scale (FMA) (time frame: "Baseline"，"Day 7"，"Day 14"). The study lists 2 primary outcomes in all. 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 20 Jul 2025.