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Active Not Recruiting
NCT07708597
Effects of Neuromuscular Electrical Stimulation Combined With Ultrasound on Stroke Patients With Sarcopenia
Conditions: Stroke, Sarcopenia
Sex: All
Ages: 30 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 152
Sponsor: Nanjing First Hospital, Nanjing Medical University
Location: Nanjing First Hospital Nanjing Jiangsu
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
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07708597). StuddyBuddy aggregates publicly available trial information.