Effects of Overground Robot-Assisted Gait Training on Stroke-Related Sarcopenia (NCT06910254) | Clinical Trial Compass
CompletedNot Applicable
Effects of Overground Robot-Assisted Gait Training on Stroke-Related Sarcopenia
South Korea53 participantsStarted 2025-06-09
Plain-language summary
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.
Who can participate
Age range19 Years – 80 Years
SexALL
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Inclusion 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:
✓. 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.
. 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:
✕. 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.