TENS for Limb Function in Stroke: Design and Rationale for a Randomized Trial

CHENGNING Song

Status: Begins enrollment in 3 months

Conditions: Stroke

Treatments: Device: High-frequency(100HZ) TENS; Device: Placebo TENS; Device: Low-frequency(2HZ) TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT06997744

KY-2025-058-0

Details and patient eligibility

About

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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 to 85 years
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

1. Uncontrolled medical, cardiovascular, or orthopedic conditions
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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156 participants in 4 patient groups, including a placebo group

2Hz TENS Group

Experimental group

Treatment:

Device: Low-frequency(2HZ) TENS

100Hz TENS Group

Experimental group

Treatment:

Device: High-frequency(100HZ) TENS

Placebo TENS Group

Placebo Comparator group

Treatment:

Device: Placebo TENS

No-treatment Control Group

No Intervention group