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NCT Number: NCT06997744

TENS for Limb Function in 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-frequency(2HZ) TENS

Device

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

Device

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

Device

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 outcomes

  1. 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.

Secondary outcomes

  1. Manual Muscle Testing (MMT) for Wrist Flexion and Extension

    Time frame: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up

    Evaluates muscle strength on a 0-5 scale, where 0 indicates no muscle activity and 5 indicates normal strength.

  2. Modified Ashworth Scale (MAS) for Wrist Flexor Spasticity

    Time frame: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up

    Measures resistance during passive muscle movement on a 0-4 scale to assess spasticity.

  3. Lindmark Motor Score - Grasp Function Subscale

    Time frame: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up

    Assesses hand grasp function on a 0-3 scale based on ability to grip and hold a tennis ball.

  4. Barthel Index

    Time frame: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up

    Evaluates independence in basic activities of daily living. Scores range from 0 to 100, with higher scores indicating greater independence.

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Lei

CONTACT

[email protected]

+86 151 0755 0352

Sponsors and collaborators

Lead sponsor

CHENGNING Song

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 30, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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