Effects of Overground Robot-Assisted Gait Training and Recumbent Bicycle Training on Muscle Characteristics, Falls Efficacy, and Physical Function in Patients With Subacute Stroke-Related Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change in Muscle Quality
研究概览
简要总结
This single-center randomized controlled trial evaluates the effects of combining overground robot-assisted gait training (o-RAGT) with recumbent cycling (RC) compared with RC alone in patients with subacute stroke at risk of sarcopenia. The study examines changes in muscle characteristics (muscle mass and quality), falls efficacy, and physical function following a 4-week intervention. Participants are randomly assigned to receive either combined o-RAGT and RC or RC alone. The findings aim to inform the potential role of overground robot-assisted gait training as an adjunctive intervention in stroke rehabilitation.
详细描述
This study is a single-center, randomized controlled trial designed to evaluate the effects of combining overground robot-assisted gait training (o-RAGT) with recumbent cycling (RC) in patients with subacute stroke at risk of sarcopenia. A total of 53 participants were randomly assigned to either an experimental group receiving combined o-RAGT and RC or a control group receiving RC alone.
The intervention was conducted five times per week for 60 minutes per session over a 4-week period. Overground robot-assisted gait training was performed using the Angel Legs M20 exoskeleton, while recumbent cycling was provided as conventional exercise training.
The primary outcomes were changes in skeletal muscle mass index, muscle quality, and falls efficacy. Secondary outcomes included measures of physical performance and functional mobility, such as the Short Physical Performance Battery, 6-Minute Walk Test, Timed Up and Go test, and lower extremity motor function.
This study aims to provide clinical information regarding the feasibility and potential effects of combining overground robot-assisted gait training with conventional exercise in stroke rehabilitation.
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
- Single (Outcomes Assessor)
盲法说明
This study employed a single-blind design. Due to the nature of the interventions, participants and therapists delivering the overground robot-assisted gait training and recumbent bicycle training could not be blinded to group allocation.
However, outcome assessors were blinded to group assignments throughout the study. All primary and secondary outcome assessments were performed by assessors who were not involved in the intervention delivery and had no access to the randomization information during data collection.
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Inclusion Criteria
- •Participants must meet all of the following criteria:
- •Diagnosis of stroke within 6 months of onset (subacute phase), corresponding to the active neurological recovery period.
- •Classified as having possible sarcopenia according to the Asian Working Group for Sarcopenia (AWGS 2019) algorithm, defined by:
- •A positive SARC-F screening, and
- •Either reduced handgrip strength (men <28 kg, women <18 kg) or reduced physical performance (SPPB score <9).
- •Height between 140 and 190 cm and body weight ≤80 kg, meeting the mechanical fitting requirements of the overground wearable gait robot used in this study.
- •Functional Ambulation Category (FAC) score ≥1, indicating the ability to attempt ambulation with at least minimal assistance.
- •Korean version of the Mini-Mental State Examination (MMSE-K) score ≥24, indicating sufficient cognitive ability to understand instructions and participate in training.
- •Currently admitted for inpatient rehabilitation at a rehabilitation hospital in Seoul, Republic of Korea.
- •Ability and willingness to provide written informed consent after receiving a full explanation of the study procedures, potential risks, and benefits.
排除标准
- •Participants will be excluded if they meet any of the following criteria:
- •Presence of severe cardiovascular disease (e.g., unstable angina, heart failure, recent myocardial infarction) or acute medical infection that contraindicates exercise-based interventions.
- •Musculoskeletal conditions that preclude safe participation in robotic gait training or recumbent cycling, including:
- •Lower extremity fractures,
- •Severe joint contractures,
- •History of lower limb joint replacement,
- •Structural deformities of the lower extremities.
- •Severe communication, psychological, or psychiatric disorders (e.g., global aphasia) that impair the ability to follow instructions or complete assessments.
- •Participation in robot-assisted gait training or similar mechanically assisted rehabilitation interventions within the past 6 months prior to enrollment.
研究组 & 干预措施
o-RAGT + Recumbent Bicycle Training
Participants in the experimental group received a combined intervention consisting of 30 minutes of overground robot-assisted gait training (o-RAGT) followed by 30 minutes of recumbent bicycle (RC) training. The o-RAGT was performed using the Angel Legs M20 wearable exoskeleton. The intervention was conducted five sessions per week for a total of 4 weeks (20 sessions).
干预措施: Overground Robot-Assisted Gait Training (o-RAGT) (Device)
o-RAGT + Recumbent Bicycle Training
Participants in the experimental group received a combined intervention consisting of 30 minutes of overground robot-assisted gait training (o-RAGT) followed by 30 minutes of recumbent bicycle (RC) training. The o-RAGT was performed using the Angel Legs M20 wearable exoskeleton. The intervention was conducted five sessions per week for a total of 4 weeks (20 sessions).
干预措施: Recumbent Bicycle Training (Device)
Recumbent Bicycle Training Only
Participants in the control group received 60 minutes of recumbent bicycle (RC) training alone to match the total exercise duration of the experimental group. The training was conducted five sessions per week for a total of 4 weeks (20 sessions).
干预措施: Recumbent Bicycle Training (Device)
结局指标
主要结局
Change in Muscle Quality
时间窗: Baseline and 4 weeks
Muscle quality will be assessed using the FITTO MQ device (Olive Healthcare, Seoul, Republic of Korea), which is based on discrete multi-wavelength near-infrared spectroscopy (DMW-NIRS). The device emits near-infrared light (650-1,100 nm) and analyzes reflected signals to estimate intramuscular composition, generating a muscle quality index (MQI). Measurements will be performed bilaterally at five muscle sites according to the standardized scan guide: erector spinae, rectus femoris, vastus lateralis, semitendinosus, and gastrocnemius. Each site will be measured twice on both the paretic and non-paretic sides, and the mean MQI value will be used for analysis. Higher MQI values indicate better muscle quality. Assessments will be conducted at baseline and after the 4-week intervention period.
Change in Fall Efficacy (K-FES-I)
时间窗: Baseline and 4 weeks
Falls efficacy will be evaluated using the Korean version of the Falls Efficacy Scale-International (K-FES-I). The K-FES-I is a validated self-reported questionnaire consisting of 16 items rated on a 4-point Likert scale, assessing concern about falling during daily activities. Although higher scores on the original scale indicate greater concern about falling, total scores will be reverse-coded for analysis in this study so that higher scores represent greater falls efficacy (i.e., less concern about falling and greater confidence during daily activities). The total score ranges from 16 to 64. Assessments will be conducted at baseline (Week 0) and after completion of the 4-week intervention (Week 4).
Change in Skeletal Muscle Mass Index (SMI)
时间窗: Baseline and 4 weeks
Skeletal muscle mass index (SMI) will be assessed using multi-frequency bioelectrical impedance analysis (BIA) with the ACCUNIQ BC720 system (T-SCAN PLUS III; SELVAS Healthcare, Seoul, Republic of Korea). This device applies electrical currents across a frequency range of 1-1,000 kHz to estimate whole-body and appendicular body composition, including skeletal muscle mass. Appendicular skeletal muscle mass (ASM) will be calculated as the sum of lean mass from both upper and lower extremities. SMI will be derived using the following formula: SMI (kg/m²) = ASM (kg) / height² (m²). Measurements will be conducted under standardized conditions with participants standing independently. Each participant will be measured twice, and the mean value will be used for analysis. Assessments will be performed at baseline and after the 4-week intervention period. Higher SMI values indicate greater skeletal muscle mass.
次要结局
- Change in Short Physical Performance Battery (SPPB) Score(Baseline and 4 weeks)
- Change in Fugl-Meyer Assessment (FMA) Lower Extremity Score(Baseline and 4 weeks)
- Change in Timed Up and Go Test (TUG)(Baseline and 4 weeks)
- Change in 6-Minute Walk Test (6MWT)(Baseline and 4 weeks)
- Change in Handgrip Strength(Baseline and 4 weeks)
研究者
Dong min park
Principal Investigator, Clinical physical therapist
Sahmyook University