NCT06910254

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Sahmyook University · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Stroke
• Sarcopenia
• Muscle Atrophy
• Mobility Limitation
• Muscle Quality
• Robotic Rehabilitation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-09
• Primary completion: 2025-11-21
• Completion: 2025-11-30
• First posted: 2025-04-04
• Last updated: 2026-01-14

Locations

1 site across 1 country: South Korea