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

Condition(s) studied

Investigational drug(s) / intervention(s)

Therapeutic Ultrasound: Ultrasound therapy delivered at 1 MHz, 0.5-0.8 W/cm², 20 minutes per session, 2 sessions per day, 6 days per week for 4 weeks, using the PHYSIOSON-EXPERT device. Applied to the affected wrist extensors and quadriceps.

Neuromuscular Electrical Stimulation: Neuromuscular electrical stimulation delivered at 50 Hz, 300μs pulse width, intensity adjusted to visible muscle contraction, 20 minutes per session, 2 sessions per day, 6 days per week for 4 weeks, using the LGT-2320D device. Applied to the affected wrist extensors and quadriceps.

Study 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

Primary outcome measure(s)

• Change in Quadriceps Muscle Thickness on the Affected Side — Baseline and 4 weeks
  Quadriceps muscle thickness on the affected (paretic) side will be measured using B-mode musculoskeletal ultrasound with a high-frequency linear probe. Muscle thickness includes the thickness of the rectus femoris and vastus intermedius. Measurements will be taken with the participant in the supine position with hips and knees extended.
• Change in Handgrip Strength — Baseline and 4 weeks
  Handgrip strength will be measured using a hand dynamometer on the unaffected side. Participants will be asked to squeeze the dynamometer with maximum effort for 3 seconds, and the average of three measurements will be recorded.
• Change in Fugl-Meyer Assessment Score — Baseline and 4 weeks
  The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is scored on a 3-point ordinal scale (0=cannot perform, 1=partially performs, 2=performs fully). Total score ranges from 0 to 100, with higher scores indicating better motor function.

Trial sites (1)

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