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StrokeNCT07708597

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

A study testing Therapeutic Ultrasound and Neuromuscular Electrical Stimulation in people with Stroke and Sarcopenia, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Stroke, Sarcopenia
What is being tested?
Therapeutic Ultrasound and Neuromuscular Electrical Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteChina
Study dates
1 May 2025to 15 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Nanjing First Hospital

    Nanjing, Jiangsu, 2100061

Other trials in China

About this study

Official title: A Randomized Controlled Trial of Neuromuscular Electrical Stimulation Combined With Therapeutic Ultrasound on Muscle Mass, Muscle Strength, and Physical Function in Stroke Patients With Sarcopenia.

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:

Read more

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

Read the detailed description

Background: Stroke is a leading cause of disability worldwide. Sarcopenia, characterized by loss of muscle mass and function, is a common complication after stroke, with a prevalence of approximately 46.7% within the first six months. Post-stroke sarcopenia significantly impairs patients' ability to walk independently, maintain balance, and perform daily activities. Current interventions primarily include exercise, physical therapy, and nutritional support, but these approaches have limitations, particularly for elderly patients who cannot tolerate vigorous exercise due to comorbidities or disability.

Therapeutic ultrasound (UT) is a non-invasive, safe, and cost-effective modality that promotes tissue regeneration and muscle repair through mechanical vibration and increased growth factor secretion. Neuromuscular electrical stimulation (NMES) induces involuntary muscle contraction, preventing disuse atrophy, preserving muscle thickness, and promoting protein synthesis. However, no study has systematically compared UT and NMES, or their combination, specifically in stroke-related sarcopenia.

Objective: This study aims to (1) compare the efficacy of UT versus NMES in improving muscle mass, strength, and physical function in stroke patients with sarcopenia; (2) evaluate whether combined UT and NMES therapy produces synergistic effects superior to either monotherapy; and (3) explore the potential mechanisms of action.

Study Design: This is a prospective, single-center, randomized, single-blind controlled trial. Eligible participants will be randomly assigned in a 1:1:1:1 ratio to one of four groups: (1) conventional rehabilitation alone (control), (2) UT + conventional rehabilitation, (3) NMES + conventional rehabilitation, or (4) combined UT + NMES + conventional rehabilitation. The intervention period is 4 weeks, with assessments performed at baseline and immediately after the intervention.

Sample Size: Based on prior literature (α = 0.05, 1-β = 0.80, effect size = 0.25), accounting for a 10% dropout rate, the total sample size is 152 participants (approximately 38 per group).

Interventions:

Conventional rehabilitation: Exercise therapy (30 min) and occupational therapy (30 min), twice daily, 6 days/week for 4 weeks.

UT group: In addition to conventional rehabilitation, UT (1 MHz, 0.5-0.8 W/cm², 20 min, 2 sessions/day, 6 days/week) applied to the affected wrist extensors and quadriceps.

NMES group: In addition to conventional rehabilitation, NMES (50 Hz, 300μs pulse width, intensity adjusted to visible muscle contraction, 20 min, 2 sessions/day, 6 days/week) applied to the same muscle groups.

Combined group: Both UT and NMES in addition to conventional rehabilitation.

Outcome Measures:

Primary outcomes: Muscle mass (muscle thickness via musculoskeletal ultrasound), muscle strength (handgrip strength, isokinetic torque), and physical function (Fugl-Meyer Assessment, Functional Independence Measure, modified Rankin Scale, balance, and gait tests).

Secondary outcomes: Surface electromyography (RMS and iEMG), Hamilton Depression Scale, and safety/adverse event monitoring.

Statistical Analysis: Data will be analyzed using SPSS 26.0. Intention-to-treat analysis will be applied. Between-group comparisons will use one-way ANOVA with post-hoc tests (LSD/Bonferroni), within-group changes will use paired t-tests, and correlation analyses will explore relationships between muscle mass improvement and functional recovery.

Ethics and Dissemination: The study has been approved by the Ethics Committee of Nanjing First Hospital (Approval Number: KY20250425-12). All participants will provide written informed consent. Results will be disseminated through peer-reviewed publications and conference presentations.

Conditions
Stroke, Sarcopenia
Being tested
Therapeutic Ultrasound, Neuromuscular Electrical Stimulation
Keywords
Neuromuscular Electrical Stimulation, Ultrasound Therapy, Post-Stroke, Rehabilitation, Muscle Atrophy Prevention
Medical subject headings
Stroke, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic UltrasoundDevice

    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 StimulationDevice

    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 groups in NCT07708597
Study groupRoleWhat they receive
Conventional Rehabilitation OnlyNo interventionParticipants 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 RehabilitationExperimentalParticipants 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.
Receives: Device: Therapeutic Ultrasound
Neuromuscular Electrical Stimulation Plus Conventional RehabilitationExperimentalParticipants 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.
Receives: Device: Neuromuscular Electrical Stimulation
Combined UT and NMES Plus Conventional RehabilitationExperimentalParticipants 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.
Receives: Device: Therapeutic Ultrasound; Device: Neuromuscular Electrical Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 4 weeks

  2. 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.

    Measured: Baseline and 4 weeks

  3. 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.

    Measured: Baseline and 4 weeks

Secondary outcomes (4)
  1. Change in Functional Independence Measure (FIM) Score

    The Functional Independence Measure (FIM) assesses functional independence across 18 items covering motor and cognitive domains. Each item is scored from 1 (total assistance required) to 7 (complete independence). Total score ranges from 18 to 126, with higher scores indicating greater independence in daily activities.

    Measured: Baseline and 4 weeks

  2. Change in Modified Rankin Scale (mRS) Score

    The modified Rankin Scale (mRS) measures the degree of disability or dependence in daily activities of participants who have had a stroke. Scores range from 0 (no symptoms) to 6 (death). Lower scores indicate better functional outcomes and greater independence.

    Measured: Baseline and 4 weeks

  3. Change in Hamilton Depression Scale (HAMD) Score

    The Hamilton Depression Scale (HAMD) assesses depressive symptoms across 17 items, including depressed mood, guilt, and insomnia. Total scores range from 0 to 42, with higher scores indicating more severe depression.

    Measured: Baseline and 4 weeks

  4. Change in Gait Speed

    Gait speed will be measured using the Gait and Balance Evaluation System during the 10-meter walk test. Participants will walk at their usual pace, and the average of three trials will be recorded in meters per second.

    Measured: Baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start1 May 2025
  3. Primary completion1 Nov 2025
  4. Study completion15 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07708597
Sponsor's protocol ID
KY20250425-12
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic Ultrasound and Neuromuscular Electrical Stimulation in people with Stroke and Sarcopenia, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Quadriceps Muscle Thickness on the Affected Side (time frame: Baseline and 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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