The Effects of Overground Robot-Assisted Gait Training (o-RAGT) and Recumbent Bicycle Training on Muscle Mass, Physical Function, and Fall Efficacy in Subacute Stroke Patients With Pre-Sarcopenia : A Randomized Controlled Trial
This study aims to evaluate the effects of overground robot-assisted gait training (o-RAGT) using a wearable robotic exoskeleton (Angel Legs M20) combined with recumbent cycling on muscle mass, physical function, and fall-related self-efficacy in patients with subacute stroke and pre-sarcopenia. Participants will be randomly assigned to either an experimental group receiving both o-RAGT and recumbent cycling, or a control group receiving recumbent cycling alone. Interventions will be performed 5 times per week for 4 weeks. Primary outcomes include changes in skeletal muscle mass (SMI), muscle quality, and fall efficacy. Secondary outcomes include balance (SPPB), gait endurance (6MWT), neurological recovery (FMA-LE), mobility (TUG), and functional ambulation (FAC). This study will help determine whether combining robotic gait training with cycling improves muscle function and rehabilitation outcomes more effectively than cycling alone. Participants will be subacute stroke patients (\< 6 months post-onset) with pre-sarcopenia diagnosed using the SARC-F questionnaire and AWGS 2019 criteria.
⁃ Participants must meet all of the following criteria:
• Subacute stroke patients within 6 months of onset.
• Height between 140 and 190 cm, and body weight ≤ 80 kg.
• Functional Ambulation Category (FAC) score ≥ 1, indicating minimal assistance required for walking.
• Mini-Mental State Examination (MMSE) score ≥ 24, indicating no more than mild cognitive impairment.
• Diagnosed with pre-sarcopenia based on the Korean version of the SARC-F questionnaire (score ≥ 4) and low skeletal muscle mass according to the Asian Working Group for Sarcopenia (AWGS 2019) criteria.