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

NCT07708597 | Active Not Recruiting

• 1 other identifier: KY20250425-12
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Stroke; Sarcopenia

Keywords

Neuromuscular Electrical Stimulation; Ultrasound Therapy; Post-Stroke; Rehabilitation; Muscle Atrophy Prevention

Outcome Measures

Primary Outcomes (3)

• Change in Quadriceps Muscle Thickness on the Affected Side

  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.

  Baseline and 4 weeks

• Change in Handgrip Strength

  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.

  Baseline and 4 weeks

• Change in Fugl-Meyer Assessment Score

  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.

  Baseline and 4 weeks

Secondary Outcomes (4)

• Change in Functional Independence Measure (FIM) Score

  Baseline and 4 weeks

• Change in Modified Rankin Scale (mRS) Score

  Baseline and 4 weeks

• Change in Hamilton Depression Scale (HAMD) Score

  Baseline and 4 weeks

• Change in Gait Speed

  Baseline and 4 weeks

Study Arms (4)

Conventional Rehabilitation Only

NO INTERVENTION

Participants receive conventional rehabilitation therapy only, including exercise therapy and occupational therapy, 2 sessions per day, 6 days per week for 4 weeks.

Ultrasound Therapy Plus Conventional Rehabilitation

EXPERIMENTAL

Participants receive conventional rehabilitation therapy plus therapeutic ultrasound (UT) applied to the affected wrist extensors and quadriceps (1 MHz, 0.5-0.8 W/cm², 20 min/session, 2 sessions/day, 6 days/week) for 4 weeks.

Device: Therapeutic Ultrasound

Neuromuscular Electrical Stimulation Plus Conventional Rehabilitation

EXPERIMENTAL

Participants receive conventional rehabilitation therapy plus neuromuscular electrical stimulation (NMES) applied to the affected wrist extensors and quadriceps (50 Hz, 300μs pulse width, intensity adjusted to visible muscle contraction, 20 min/session, 2 sessions/day, 6 days/week) for 4 weeks.

Device: Neuromuscular Electrical Stimulation

Combined UT and NMES Plus Conventional Rehabilitation

EXPERIMENTAL

Participants receive conventional rehabilitation therapy plus both therapeutic ultrasound (UT) and neuromuscular electrical stimulation (NMES) applied to the affected wrist extensors and quadriceps, using the same parameters as the single-therapy groups, for 4 weeks.

Device: Therapeutic Ultrasound; Device: Neuromuscular Electrical Stimulation

Interventions

Therapeutic Ultrasound DEVICE

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.

Combined UT and NMES Plus Conventional Rehabilitation; Ultrasound Therapy Plus Conventional Rehabilitation

Neuromuscular Electrical Stimulation DEVICE

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.

Combined UT and NMES Plus Conventional Rehabilitation; Neuromuscular Electrical Stimulation Plus Conventional Rehabilitation

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 2100061, China

Location

MeSH Terms

Conditions

Stroke; Sarcopenia

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and the outcome assessors are masked to group allocation. The care providers (therapists) are not masked because they must operate the ultrasound and NMES devices, which requires knowledge of the assigned intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to one of four parallel groups: conventional rehabilitation alone, conventional rehabilitation plus ultrasound therapy, conventional rehabilitation plus neuromuscular electrical stimulation, or conventional rehabilitation plus both interventions.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: May 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: July 15, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)