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COMPLETED

NCT06910254

Effects of Overground Robot-Assisted Gait Training on Stroke-Related Sarcopenia

Sponsor: Sahmyook University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

19 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-09

Completion Date

2025-11-30

Last Updated

2026-05-01

Healthy Volunteers

Conditions

Stroke Sarcopenia Muscle Atrophy Mobility Limitation Muscle Quality Robotic Rehabilitation

Interventions

DEVICE

Overground Robot-Assisted Gait Training (o-RAGT)

This intervention consists of overground robot-assisted gait training (o-RAGT) performed using the Angel Legs M20 wearable exoskeleton (Angel Robotics, Seoul, Republic of Korea). Participants perform structured overground walking practice with robotic assistance during scheduled training sessions. The device is used to support repetitive, task-specific overground gait practice under supervised clinical conditions.

DEVICE

Recumbent Bicycle Training

Participants perform recumbent bicycle training using a stationary recumbent cycle ergometer (DRAX TBR9000, Republic of Korea). Training is conducted in a seated position with lower-extremity pedaling at a prescribed intensity. Each session is performed according to the study protocol under supervised clinical conditions.

\- Inclusion Criteria Participants must meet all of the following criteria: 1. Diagnosis of stroke within 6 months of onset (subacute phase), corresponding to the active neurological recovery period. 2. 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). 3. 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. 4. Functional Ambulation Category (FAC) score ≥1, indicating the ability to attempt ambulation with at least minimal assistance. 5. Korean version of the Mini-Mental State Examination (MMSE-K) score ≥24, indicating sufficient cognitive ability to understand instructions and participate in training. 6. Currently admitted for inpatient rehabilitation at a rehabilitation hospital in Seoul, Republic of Korea. 7. Ability and willingness to provide written informed consent after receiving a full explanation of the study procedures, potential risks, and benefits. * Exclusion Criteria Participants will be excluded if they meet any of the following criteria: 1. Presence of severe cardiovascular disease (e.g., unstable angina, heart failure, recent myocardial infarction) or acute medical infection that contraindicates exercise-based interventions. 2. 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. 3. Severe communication, psychological, or psychiatric disorders (e.g., global aphasia) that impair the ability to follow instructions or complete assessments. 4. Participation in robot-assisted gait training or similar mechanically assisted rehabilitation interventions within the past 6 months prior to enrollment.

Locations (1)

Sahmyook University

Seoul, South Korea