StrokeNCT06997744
TENS for Limb Function in Stroke: Design and Rationale for a Randomized Trial
A study testing Low-frequency(2HZ) TENS and High-frequency(100HZ) TENS in people with Stroke, run by CHENGNING Song at 1 site in China.
Trial summary
This study tests whether slow or fast electrical nerve stimulation (TENS) works better to improve arm movement in people recovering from a stroke. Participants will receive TENS on their weak arm three times a week for eight weeks. The results will help find the best TENS setting to support stroke recovery. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Low-frequency(2HZ) TENS and High-frequency(100HZ) TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Sep 2028
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 85 years
- Clinical diagnosis of stroke (ischemic or hemorrhagic) within the past 10 days to 2 months
- Presence of voluntary movement in the non-paretic arm and at least minimal antigravity movement in the paretic shoulder
- At least 5 degrees of active wrist extension on the paretic side
- Able to provide informed consent
Who cannot join
- Uncontrolled medical, cardiovascular, or orthopedic conditions
- Contraindications to TENS (e.g., implanted cardiac pacemaker, skin allergies)
- Receptive aphasia preventing informed consent or cooperation
- Significant peripheral neuropathy affecting upper limbs
- Current participation in another clinical trial or drug study
- Severe contractures in the shoulder, elbow, wrist, or fingers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuyong People's Hospital, Bao'an District, Shenzhen
Shenzhen, Guangdong, 529000
+8618822864744, scn1037508590@163.com
About this study
Official title: Comparative Effects of 2Hz Versus 100Hz Transcutaneous Electrical Nerve Stimulation on Upper Limb Motor Function Post-Stroke: Design and Rationale for a Randomized Trial
This study tests whether slow or fast electrical nerve stimulation (TENS) works better to improve arm movement in people recovering from a stroke. Participants will receive TENS on their weak arm three times a week for eight weeks. The results will help find the best TENS setting to support stroke recovery.
- Conditions
- Stroke
- Being tested
- Low-frequency(2HZ) TENS, High-frequency(100HZ) TENS, Placebo TENS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-frequency(2HZ) TENSDevice
Participants receive transcutaneous electrical nerve stimulation (TENS) at a frequency of 2Hz. The stimulation is delivered using surface electrodes placed on the affected upper limb. Each session lasts 30 minutes and is conducted three times per week for a total of 8 weeks. Intensity is gradually increased from 1 mA to 3 mA during each session.
High-frequency(100HZ) TENSDevice
Participants receive TENS at a frequency of 100Hz using the same electrode placement and schedule as the 2Hz group. Sessions last 30 minutes, three times weekly for 8 weeks, with intensity increasing from 1 mA to 3 mA across the session. This group represents high-frequency stimulation.
Placebo TENSDevice
Participants use a TENS device identical in appearance to the active treatment units. The power light is on, but no electrical stimulation is delivered due to internal circuit disconnection. Sessions follow the same schedule and duration as the active groups.
| Study group | Role | What they receive |
|---|---|---|
| 2Hz TENS Group | Experimental | Not described Receives: Device: Low-frequency(2HZ) TENS |
| 100Hz TENS Group | Experimental | Not described Receives: Device: High-frequency(100HZ) TENS |
| Placebo TENS Group | Placebo comparator | Not described Receives: Device: Placebo TENS |
| No-treatment Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Assesses upper limb motor function in stroke patients, including shoulder, elbow, wrist, and hand movements. Scores range from 0 to 66, with higher scores indicating better motor function.
Measured: Baseline, Week 4, Week 8, 1-month follow-up, and 3-month follow-up
Secondary outcomes (4)
Manual Muscle Testing (MMT) for Wrist Flexion and Extension
Evaluates muscle strength on a 0-5 scale, where 0 indicates no muscle activity and 5 indicates normal strength.
Measured: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up
Modified Ashworth Scale (MAS) for Wrist Flexor Spasticity
Measures resistance during passive muscle movement on a 0-4 scale to assess spasticity.
Measured: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up
Lindmark Motor Score - Grasp Function Subscale
Assesses hand grasp function on a 0-3 scale based on ability to grip and hold a tennis ball.
Measured: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up
Barthel Index
Evaluates independence in basic activities of daily living. Scores range from 0 to 100, with higher scores indicating greater independence.
Measured: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHENGNING Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CHENGNING Song, Shenzhen Baoan District Fuyong People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997744
- Sponsor's protocol ID
- KY-2025-111
- Status last verified
- Aug 2025
- First submitted
- 21 May 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of 2Hz Versus 100Hz Transcutaneous Electrical Nerve Stimulation on Upper Limb Motor Function Post-Stroke: Design and Rationale for a Randomized Trial
- ClinicalTrials.gov ID
- NCT06997744
- Acronym / sponsor ID
- KY-2025-111
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- CHENGNING SongUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 30 May 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.
This study tests whether slow or fast electrical nerve stimulation (TENS) works better to improve arm movement in people recovering from a stroke. Participants will receive TENS on their weak arm three times a week for eight weeks. The results will help find the best TENS setting to support stroke recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2Hz TENS Group | Experimental | Device: Low-frequency(2HZ) TENS |
| 100Hz TENS Group | Experimental | Device: High-frequency(100HZ) TENS |
| Placebo TENS Group | Placebo comparator | Device: Placebo TENS |
| No-treatment Control Group | No intervention | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 85 years
- Clinical diagnosis of stroke (ischemic or hemorrhagic) within the past 10 days to 2 months
- Presence of voluntary movement in the non-paretic arm and at least minimal antigravity movement in the paretic shoulder
- At least 5 degrees of active wrist extension on the paretic side
- Able to provide informed consent
Key exclusion criteria (6 listed)
- Uncontrolled medical, cardiovascular, or orthopedic conditions
- Contraindications to TENS (e.g., implanted cardiac pacemaker, skin allergies)
- Receptive aphasia preventing informed consent or cooperation
- Significant peripheral neuropathy affecting upper limbs
- Current participation in another clinical trial or drug study
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(2HZ) TENSParticipants receive transcutaneous electrical nerve stimulation (TENS) at a frequency of 2Hz. The stimulation is delivered using surface electrodes placed on the affected upper limb. Each session lasts 30 minutes and is conducted three times per week for a total of 8 weeks. Intensity is gradually increased from 1 mA to 3 mA during each session. | Device | 2Hz TENS Group |
| High-frequency(100HZ) TENSParticipants receive TENS at a frequency of 100Hz using the same electrode placement and schedule as the 2Hz group. Sessions last 30 minutes, three times weekly for 8 weeks, with intensity increasing from 1 mA to 3 mA across the session. This group represents high-frequency stimulation. | Device | 100Hz TENS Group |
| Placebo TENSParticipants use a TENS device identical in appearance to the active treatment units. The power light is on, but no electrical stimulation is delivered due to internal circuit disconnection. Sessions follow the same schedule and duration as the active groups. | Device | Placebo TENS Group |
Primary outcome
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: Baseline, Week 4, Week 8, 1-month follow-up, and 3-month follow-up
Assesses upper limb motor function in stroke patients, including shoulder, elbow, wrist, and hand movements. Scores range from 0 to 66, with higher scores indicating better motor function.
4 secondary outcomes
Manual Muscle Testing (MMT) for Wrist Flexion and Extension
Time frame: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up
Modified Ashworth Scale (MAS) for Wrist Flexor Spasticity
Time frame: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up
Lindmark Motor Score - Grasp Function Subscale
Time frame: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up
Barthel Index
Time frame: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up
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 28 Aug 2025.
- Individual participant dataSharing planned: Yes
Related trials for Stroke
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-frequency(2HZ) TENS and High-frequency(100HZ) TENS in people with Stroke, run by CHENGNING Song 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 5 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: opening soon, as of the sponsor's last update on 28 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. Some participants in this study may receive a placebo. 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 Bo Lei (+86 151 0755 0352, szleidoctor@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 for Upper Extremity (FMA-UE) (time frame: Baseline, Week 4, Week 8, 1-month follow-up, and 3-month follow-up). 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 28 Aug 2025.