Active — Not RecruitingNot Applicable

Effects of Neuromuscular Electrical Stimulation Combined With Ultrasound on Stroke Patients With Sarcopenia

China152 participantsStarted 2025-05-01

Plain-language summary

The goal of this clinical trial is to learn if combining neuromuscular electrical stimulation (NMES) with therapeutic ultrasound (UT) can improve muscle mass, muscle strength, and physical function in stroke patients with sarcopenia. The main questions it aims to answer are: Does combined NMES and UT therapy increase muscle mass and strength more than conventional rehabilitation alone? Does the combined therapy improve physical function (balance, gait, and activities of daily living) better than either therapy alone? Researchers will compare four groups: Conventional rehabilitation only (control group) Conventional rehabilitation plus UT Conventional rehabilitation plus NMES Conventional rehabilitation plus combined UT and NMES Participants will: Receive 4 weeks of rehabilitation therapy, 6 days per week Undergo assessments of muscle mass (via ultrasound), muscle strength (handgrip, isokinetic testing), and physical function (Fugl-Meyer, FIM, balance, and gait tests) before and after the 4-week intervention Receive either UT (1 MHz, 0.5-0.8 W/cm², 20 min/session, 2 sessions/day), NMES (50 Hz, 300μs pulse width, 20 min/session, 2 sessions/day), both, or standard care only

Who can participate

Age range

30 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of first-ever stroke confirmed by CT or MRI, with stable vital signs, disease course between 3 weeks and 6 months. Diagnosis of sarcopenia according to the 2019 Asian Working Group for Sarcopenia (AWGS) criteria: reduced handgrip strength (male \< 28 kg, female \< 18 kg) and/or gait speed \< 1.0 m/s, and reduced appendicular skeletal muscle mass index (male \< 7.0 kg/m², female \< 5.4 kg/m²). Age between 30 and 75 years. Brunnstrom stage of affected upper and lower limbs ≥ III, and modified Ashworth scale ≤ 2. No significant consciousness or cognitive impairment. Willing and able to provide written informed consent. Exclusion Criteria: * Presence of significant emotional or cognitive impairment. Obesity or overweight (body mass index \> 25 kg/m²). Unable to stand up from a chair with or without assistance. Comorbidities including renal, hepatic, or heart failure.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Quadriceps Muscle Thickness on the Affected Side

Timeframe: Baseline and 4 weeks

Change in Handgrip Strength

Timeframe: Baseline and 4 weeks

Change in Fugl-Meyer Assessment Score

Timeframe: Baseline and 4 weeks

Trial details

NCT IDNCT07708597

SponsorNanjing First Hospital, Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-01

View on ClinicalTrials.gov More Stroke trials

Plain-language summary

Who can participate

Age range

30 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.