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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Change in Quadriceps Muscle Thickness on the Affected Side
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •No significant consciousness or cognitive impairment.
- •Willing and able to provide written informed consent.
排除标准
- •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.
结局指标
主要结局
Change in Quadriceps Muscle Thickness on the Affected Side
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
XuePing Li
Principal Investigator
Nanjing First Hospital, Nanjing Medical University