Effects of Neuromuscular Electrical Stimulation Combined With Ultrasound on Stroke Patients With Sarcopenia
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:
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Jiangsu
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Nanjing, Jiangsu, China, 2100061
- Nanjing First Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Conventional Rehabilitation Only
Participants receive conventional rehabilitation therapy only, including exercise therapy and occupational therapy, 2 sessions per day, 6 days per week for 4 weeks.
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Experimenteel: Ultrasound Therapy Plus Conventional Rehabilitation
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.
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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.
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Experimenteel: Neuromuscular Electrical Stimulation Plus Conventional Rehabilitation
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.
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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.
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Experimenteel: Combined UT and NMES Plus Conventional Rehabilitation
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.
|
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 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Quadriceps Muscle Thickness on the Affected Side
Tijdsspanne: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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Change in Handgrip Strength
Tijdsspanne: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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Change in Fugl-Meyer Assessment Score
Tijdsspanne: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Functional Independence Measure (FIM) Score
Tijdsspanne: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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Change in Modified Rankin Scale (mRS) Score
Tijdsspanne: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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Change in Hamilton Depression Scale (HAMD) Score
Tijdsspanne: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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Change in Gait Speed
Tijdsspanne: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neurologische manifestaties
- Cerebrovasculaire aandoeningen
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Vaatziekten
- Hart-en vaatziekten
- Neuromusculaire manifestaties
- Pathologische aandoeningen, anatomisch
- Spieratrofie
- Atrofie
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Hartinfarct
- Sarcopenie
- Therapeutica
- Diathermie
- Hyperthermie, geïnduceerd
- Ultrasone therapie
Andere studie-ID-nummers
- KY20250425-12
Plan Individuele Deelnemersgegevens (IPD)
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