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

April 27, 2026 updated by: Dong min park, Sahmyook University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 01795
        • Sahmyook University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

- 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: o-RAGT + Recumbent Bicycle Training
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).
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.
Other Names:
  • Angel Legs M20 wearable exoskeleton
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.
Other Names:
  • Recumbent ergometer
Active Comparator: Recumbent Bicycle Training Only
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).
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.
Other Names:
  • Recumbent ergometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Muscle Quality
Time Frame: Baseline and 4 weeks

Muscle quality will be assessed using the FITTO MQ device (Olive Healthcare, Seoul, Republic of Korea), which is based on discrete multi-wavelength near-infrared spectroscopy (DMW-NIRS). The device emits near-infrared light (650-1,100 nm) and analyzes reflected signals to estimate intramuscular composition, generating a muscle quality index (MQI).

Measurements will be performed bilaterally at five muscle sites according to the standardized scan guide: erector spinae, rectus femoris, vastus lateralis, semitendinosus, and gastrocnemius. Each site will be measured twice on both the paretic and non-paretic sides, and the mean MQI value will be used for analysis. Higher MQI values indicate better muscle quality. Assessments will be conducted at baseline and after the 4-week intervention period.
Baseline and 4 weeks
Change in Fall Efficacy (K-FES-I)
Time Frame: Baseline and 4 weeks

Falls efficacy will be evaluated using the Korean version of the Falls Efficacy Scale-International (K-FES-I). The K-FES-I is a validated self-reported questionnaire consisting of 16 items rated on a 4-point Likert scale, assessing concern about falling during daily activities.

Although higher scores on the original scale indicate greater concern about falling, total scores will be reverse-coded for analysis in this study so that higher scores represent greater falls efficacy (i.e., less concern about falling and greater confidence during daily activities). The total score ranges from 16 to 64.

Assessments will be conducted at baseline (Week 0) and after completion of the 4-week intervention (Week 4).
Baseline and 4 weeks
Change in Skeletal Muscle Mass Index (SMI)
Time Frame: Baseline and 4 weeks

Skeletal muscle mass index (SMI) will be assessed using multi-frequency bioelectrical impedance analysis (BIA) with the ACCUNIQ BC720 system (T-SCAN PLUS III; SELVAS Healthcare, Seoul, Republic of Korea). This device applies electrical currents across a frequency range of 1-1,000 kHz to estimate whole-body and appendicular body composition, including skeletal muscle mass.

Appendicular skeletal muscle mass (ASM) will be calculated as the sum of lean mass from both upper and lower extremities. SMI will be derived using the following formula:

SMI (kg/m²) = ASM (kg) / height² (m²).

Measurements will be conducted under standardized conditions with participants standing independently. Each participant will be measured twice, and the mean value will be used for analysis. Assessments will be performed at baseline and after the 4-week intervention period. Higher SMI values indicate greater skeletal muscle mass.
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Short Physical Performance Battery (SPPB) Score
Time Frame: Baseline and 4 weeks

Physical function will be assessed using the electronic Short Physical Performance Battery (eSPPB; SPPB-100, Cybermedic Co., Seoul, Republic of Korea). The SPPB consists of three components: balance test (side-by-side, semi-tandem, and tandem stance), 4-meter gait speed test, and 5-times chair stand test. Each component is scored from 0 to 4 based on performance, yielding a total score ranging from 0 to 12, with higher scores indicating better physical performance.

All assessments will be conducted by trained physical therapists with at least 3 years of clinical experience, who are blinded to group allocation. The eSPPB system incorporates infrared distance sensors, pressure sensors, and a balance platform to automatically detect task initiation and completion, thereby minimizing examiner-related timing errors and improving measurement reliability. Assessments will be performed at baseline and after the 4-week intervention period.
Baseline and 4 weeks
Change in Timed Up and Go Test (TUG)
Time Frame: Baseline and 4 weeks

Functional mobility and dynamic balance will be assessed using the Timed Up and Go test (TUG). Participants will be instructed to rise from a chair with armrests, walk 3 meters at a comfortable pace, turn around, return to the chair, and sit down. The time required to complete the task will be recorded in seconds (to the nearest 0.1 s).

Each participant will perform two trials using standardized verbal instructions, and the mean value will be used for analysis. Assessments will be conducted by trained physical therapists with at least 3 years of clinical experience. Testing will be discontinued if adverse events such as dizziness, pain, or unstable gait are observed. Lower TUG times indicate better functional mobility. Assessments will be performed at baseline and after the 4-week intervention period.
Baseline and 4 weeks
Change in Fugl-Meyer Assessment (FMA) Lower Extremity Score
Time Frame: Baseline and 4 weeks

Lower extremity motor function will be assessed using the Fugl-Meyer Assessment for the Lower Extremity (FMA-LE), a standardized and widely used measure based on the neurological recovery framework for post-stroke motor impairment. The FMA-LE consists of 17 items scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), yielding a total score ranging from 0 to 34, with higher scores indicating better voluntary motor control and coordination of the lower extremity.

The assessment includes three subdomains: reflex activity, voluntary movement, and coordination/speed, covering selective movements of the hip, knee, and ankle. All assessments will be conducted by trained physical therapists with at least 3 years of clinical experience using standardized procedures. Assessments will be performed at baseline and after the 4-week intervention period.
Baseline and 4 weeks
Change in 6-Minute Walk Test (6MWT)
Time Frame: Baseline and 4 weeks

Functional ambulation capacity and exercise tolerance will be assessed using the 6-Minute Walk Test (6MWT), conducted in accordance with the American Thoracic Society (ATS) guidelines. Participants will be instructed to walk as far as possible for 6 minutes at a self-selected pace, with the option to slow down or rest if needed. The total distance walked will be recorded in meters, with greater distances indicating better walking endurance and functional mobility.

The test will be performed in a controlled indoor environment using a 40-meter rectangular loop track with a flat, non-elastic surface. Standardized verbal instructions and encouragement will be provided at 1-minute intervals. Participants may use their usual walking aids if required. The test will be discontinued immediately if adverse symptoms such as dizziness, chest pain, or severe fatigue occur. Assessments will be conducted at baseline and after the 4-week intervention period.
Baseline and 4 weeks
Change in Handgrip Strength
Time Frame: Baseline and 4 weeks

Upper extremity muscle strength will be assessed using a digital handgrip dynamometer (TAKEI T.K.K.5401; Takei Scientific Instruments Co., Niigata, Japan). Measurements will be performed with participants seated, feet flat on the floor, shoulder in a neutral position, elbow flexed at 90°, and wrist in a neutral position. Handle span will be adjusted to fit each participant's hand size.

Participants will be instructed to perform a maximal isometric contraction for 3-5 seconds. Two trials will be conducted for each hand, with a rest period of 30-60 seconds between trials to minimize fatigue. The maximum and mean values (kg) will be recorded for analysis. Lower grip strength values indicate reduced upper extremity muscle strength. Assessments will be conducted at baseline and after the 4-week intervention period.
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahmyook University

Investigators

  • Principal Investigator: Seungwon Lee, PhD, Sahmyook University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2025

Primary Completion (Actual)

November 21, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYU 2025-01-010-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared outside the research team due to institutional policies and privacy regulations. Data will be securely stored and used solely for the purpose of this study and related publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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