Effects of Overground Robot-Assisted Gait Training on Stroke-Related Sarcopenia (oRAGT-PSS)

Sahmyook University

Status: Completed

Conditions: Muscle Atrophy; Stroke; Muscle Quality; Mobility Limitation; Sarcopenia; Robotic Rehabilitation

Treatments: Device: Recumbent Bicycle Training; Device: Overground Robot-Assisted Gait Training (o-RAGT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06910254

SYU 2025-01-010-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

- 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

o-RAGT + Recumbent Bicycle Training

Experimental group

Description:

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).

Treatment:

Device: Overground Robot-Assisted Gait Training (o-RAGT)

Device: Recumbent Bicycle Training

Recumbent Bicycle Training Only

Active Comparator group

Description:

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).

Treatment:

Device: Recumbent Bicycle Training