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

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

Overview

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.

Interventions

• Device 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.
• Device 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.
• Device 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.

Primary outcome measures

• Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [Time frame: Baseline, Week 4, Week 8, 1-month follow-up, and 3-month follow-up]

Secondary outcome measures (4)

• 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]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Fuyong People's Hospital, Bao'an District, Shenzhen — Shenzhen

Identifiers

NCT: NCT06997744 · KY-2025-111

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗