TENS for Limb Function in Stroke: Design and Rationale for a Randomized Trial
NCT ID: NCT06997744
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
156 participants
INTERVENTIONAL
2025-10-01
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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2Hz TENS Group
Low-frequency(2HZ) TENS
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.
100Hz TENS Group
High-frequency(100HZ) TENS
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 TENS Group
Placebo TENS
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.
No-treatment Control Group
No interventions assigned to this group
Interventions
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Low-frequency(2HZ) TENS
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) TENS
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 TENS
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.
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of stroke (ischemic or hemorrhagic) within the past 10 days to 2 months
3. Presence of voluntary movement in the non-paretic arm and at least minimal antigravity movement in the paretic shoulder
4. At least 5 degrees of active wrist extension on the paretic side
5. Able to provide informed consent
Exclusion Criteria
2. Contraindications to TENS (e.g., implanted cardiac pacemaker, skin allergies)
3. Receptive aphasia preventing informed consent or cooperation
4. Significant peripheral neuropathy affecting upper limbs
5. Current participation in another clinical trial or drug study
6. Severe contractures in the shoulder, elbow, wrist, or fingers
40 Years
80 Years
ALL
No
Sponsors
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CHENGNING Song
OTHER
Responsible Party
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CHENGNING Song
Doctor
Locations
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Fuyong People's Hospital, Bao'an District, Shenzhen
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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KY-2025-111
Identifier Type: -
Identifier Source: org_study_id
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