StrokeoRAGT-PSSNCT06910254

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

A study testing Overground Robot-Assisted Gait Training (o-RAGT) and Recumbent Bicycle Training in people with Stroke and Sarcopenia, run by Sahmyook University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 to 80 years
Conditions the study is for: Stroke, Sarcopenia, Muscle Atrophy
What is being tested?: Overground Robot-Assisted Gait Training (o-RAGT) and Recumbent Bicycle Training
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteSouth Korea
Study dates: 9 Jun 2025to 30 Nov 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Participants will be excluded if they meet any of the following criteria:
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:
Lower extremity fractures,
Severe joint contractures,
History of lower limb joint replacement,

Show all 9Show fewer

Structural deformities of the lower extremities.
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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Sahmyook University
Seoul, 01795

Other trials in South Korea

About this study

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

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.

Read the 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
Being tested: Overground Robot-Assisted Gait Training (o-RAGT), Recumbent Bicycle Training
Keywords: subacute stroke, sarcopenia, Overground Robot-Assisted Gait Training (o-RAGT), Robotic rehabilitation, Muscle Quality, Skeletal muscle mass, Falls Efficacy, Exoskeleton Robot
Medical subject headings: Stroke, Sarcopenia, Muscular Atrophy, Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Overground Robot-Assisted Gait Training (o-RAGT)Device
Also called Angel Legs M20 wearable exoskeleton
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.
Recumbent Bicycle TrainingDevice
Also called Recumbent ergometer
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.

Study groups in NCT06910254
Study group	Role	What they receive
o-RAGT + Recumbent Bicycle Training	Experimental	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). Receives: Device: Overground Robot-Assisted Gait Training (o-RAGT); Device: Recumbent Bicycle Training
Recumbent Bicycle Training Only	Active comparator	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). Receives: Device: Recumbent Bicycle Training

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Muscle Quality
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.
Measured: Baseline and 4 weeks
Change in Fall Efficacy (K-FES-I)
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).
Measured: Baseline and 4 weeks
Change in Skeletal Muscle Mass Index (SMI)
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.
Measured: Baseline and 4 weeks

Secondary outcomes (5)

Change in Short Physical Performance Battery (SPPB) Score
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.
Measured: Baseline and 4 weeks
Change in Timed Up and Go Test (TUG)
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.
Measured: Baseline and 4 weeks
Change in Fugl-Meyer Assessment (FMA) Lower Extremity Score
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.
Measured: Baseline and 4 weeks
Change in 6-Minute Walk Test (6MWT)
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.
Measured: Baseline and 4 weeks
Change in Handgrip Strength
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.
Measured: Baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jun 202530 Nov 2025

First posted4 Apr 2025
Study start9 Jun 2025
Primary completion21 Nov 2025
Study completion30 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study is a single-center, randomized controlled trial with a two-arm parallel-group design. A total of 53 participants with subacute stroke-related sarcopenia were randomly assigned to either an experimental group or a control group. Both groups received a 4-week intervention consisting of five 60-minute sessions per week. Participants in the experimental group received 30 minutes of overground robot-assisted gait training (o-RAGT) using the Angel Legs M20 exoskeleton, followed by 30 minutes of recumbent bicycle (RC) training. Participants in the control group received 60 minutes of recumbent bicycle training alone. Per-protocol analyses were conducted for participants who completed the full intervention and outcome assessments, resulting in a final sample of 41 participants (experimental group, n=19; control group, n=22).
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06910254
Sponsor's protocol ID: SYU 2025-01-010-001
Acronym: oRAGT-PSS
Status last verified: Apr 2026
First submitted: 17 Mar 2025
Last updated: 1 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

Gault ML, Willems ME. Aging, functional capacity and eccentric exercise training. Aging Dis. 2013 Sep 25;4(6):351-63. doi: 10.14336/AD.2013.0400351.
PubMed 24307968
Iyanaga T, Abe H, Oka T, Miura T, Iwasaki R, Takase M, Isatake M, Doi A. Recumbent cycling with integrated volitional control electrical stimulation improves gait speed during the recovery stage in stroke patients. J Exerc Rehabil. 2019 Feb 25;15(1):95-102. doi: 10.12965/jer.1836500.250. eCollection 2019 Feb.
PubMed 30899743
da Rosa Pinheiro DR, Cabeleira MEP, da Campo LA, Correa PS, Blauth AHEG, Cechetti F. Effects of aerobic cycling training on mobility and functionality of acute stroke subjects: A randomized clinical trial. NeuroRehabilitation. 2021;48(1):39-47. doi: 10.3233/NRE-201585.
PubMed 33386826
Gonzalez-Rocha A, Mendez-Sanchez L, Ortiz-Rodriguez MA, Denova-Gutierrez E. Effect Of Exercise on Muscle Mass, Fat Mass, Bone Mass, Muscular Strength and Physical Performance in Community Dwelling Older Adults: Systematic Review and Meta-Analysis. Aging Dis. 2022 Oct 1;13(5):1421-1435. doi: 10.14336/AD.2022.0215. eCollection 2022 Oct 1.
PubMed 36186132
Shin J, Park E. Comparison between Discrete Multi-Wavelength Near-Infrared Spectroscopy and Bioelectrical Impedance Analysis in the Assessment of Muscle Mass for Community-Dwelling Older People. J Clin Med. 2024 Apr 18;13(8):2350. doi: 10.3390/jcm13082350.
PubMed 38673621
Menon RG, Raghavan P, Regatte RR. Quantifying muscle glycosaminoglycan levels in patients with post-stroke muscle stiffness using T1rho MRI. Sci Rep. 2019 Oct 10;9(1):14513. doi: 10.1038/s41598-019-50715-x.
PubMed 31601831
Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
PubMed 24461239
Choi AY, Lim JH, Kim BG. Effects of muscle strength exercise on muscle mass and muscle strength in patients with stroke: a systematic review and meta-analysis. J Exerc Rehabil. 2024 Oct 25;20(5):146-157. doi: 10.12965/jer.2448428.214. eCollection 2024 Oct.
PubMed 39502116
Hu MM, Wang S, Wu CQ, Li KP, Geng ZH, Xu GH, Dong L. Efficacy of robot-assisted gait training on lower extremity function in subacute stroke patients: a systematic review and meta-analysis. J Neuroeng Rehabil. 2024 Sep 19;21(1):165. doi: 10.1186/s12984-024-01463-1.
PubMed 39300491
Calafiore D, Negrini F, Tottoli N, Ferraro F, Ozyemisci-Taskiran O, de Sire A. Efficacy of robotic exoskeleton for gait rehabilitation in patients with subacute stroke : a systematic review. Eur J Phys Rehabil Med. 2022 Feb;58(1):1-8. doi: 10.23736/S1973-9087.21.06846-5. Epub 2021 Jul 12.
PubMed 34247470
Lorusso M, Tramontano M, Casciello M, Pece A, Smania N, Morone G, Tamburella F. Efficacy of Overground Robotic Gait Training on Balance in Stroke Survivors: A Systematic Review and Meta-Analysis. Brain Sci. 2022 May 31;12(6):713. doi: 10.3390/brainsci12060713.
PubMed 35741599
Su Y, Yuki M, Otsuki M. Prevalence of stroke-related sarcopenia: A systematic review and meta-analysis. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):105092. doi: 10.1016/j.jstrokecerebrovasdis.2020.105092. Epub 2020 Jul 3.
PubMed 32807486
Louie DR, Mortenson WB, Durocher M, Teasell R, Yao J, Eng JJ. Exoskeleton for post-stroke recovery of ambulation (ExStRA): study protocol for a mixed-methods study investigating the efficacy and acceptance of an exoskeleton-based physical therapy program during stroke inpatient rehabilitation. BMC Neurol. 2020 Jan 28;20(1):35. doi: 10.1186/s12883-020-1617-7.
PubMed 31992219
Scherbakov N, Doehner W. Sarcopenia in stroke-facts and numbers on muscle loss accounting for disability after stroke. J Cachexia Sarcopenia Muscle. 2011 Mar;2(1):5-8. doi: 10.1007/s13539-011-0024-8. Epub 2011 Mar 25.
PubMed 21475676

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06910254
Acronym / sponsor ID: oRAGT-PSS / SYU 2025-01-010-001
Conditions: Stroke, Sarcopenia, Muscle Atrophy, Mobility Limitation, Muscle Quality, Robotic Rehabilitation
Keywords: subacute stroke, sarcopenia, Overground Robot-Assisted Gait Training (o-RAGT), Robotic rehabilitation, Muscle Quality, Skeletal muscle mass, Falls Efficacy, Exoskeleton Robot
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Sahmyook UniversityUniversity, hospital or other
Study start: 9 Jun 2025 (actual)
Primary completion: 21 Nov 2025 (actual)
Study completion: 30 Nov 2025 (actual)
First posted: 4 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: This study is a single-center, randomized controlled trial with a two-arm parallel-group design. A total of 53 participants with subacute stroke-related sarcopenia were randomly assigned to either an experimental group or a control group. Both groups received a 4-week intervention consisting of five 60-minute sessions per week. Participants in the experimental group received 30 minutes of overground robot-assisted gait training (o-RAGT) using the Angel Legs M20 exoskeleton, followed by 30 minutes of recumbent bicycle (RC) training. Participants in the control group received 60 minutes of recumbent bicycle training alone. Per-protocol analyses were conducted for participants who completed the full intervention and outcome assessments, resulting in a final sample of 41 participants (experimental group, n=19; control group, n=22).

Arm	Type	Receives
o-RAGT + Recumbent Bicycle Training	Experimental	Device: Overground Robot-Assisted Gait Training (o-RAGT), Device: Recumbent Bicycle TrainingParticipants 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).
Recumbent Bicycle Training Only	Active comparator	Device: Recumbent Bicycle TrainingParticipants 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).

Who may qualify

Ages: 19 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Overground Robot-Assisted Gait Training (o-RAGT)Also: Angel Legs M20 wearable exoskeletonThis 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	o-RAGT + Recumbent Bicycle Training
Recumbent Bicycle TrainingAlso: Recumbent ergometerParticipants 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.	Device	Recumbent Bicycle Training Only, o-RAGT + Recumbent Bicycle Training

Primary outcome

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.
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).
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.

5 secondary outcomes

Change in Short Physical Performance Battery (SPPB) Score
Time frame: Baseline and 4 weeks
Change in Timed Up and Go Test (TUG)
Time frame: Baseline and 4 weeks
Change in Fugl-Meyer Assessment (FMA) Lower Extremity Score
Time frame: Baseline and 4 weeks
Change in 6-Minute Walk Test (6MWT)
Time frame: Baseline and 4 weeks
Change in Handgrip Strength
Time frame: Baseline and 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Background: PubMed 24307968Gault ML, Willems ME. Aging, functional capacity and eccentric exercise training. Aging Dis. 2013 Sep 25;4(6):351-63. doi: 10.14336/AD.2013.0400351.
Background: PubMed 30899743Iyanaga T, Abe H, Oka T, Miura T, Iwasaki R, Takase M, Isatake M, Doi A. Recumbent cycling with integrated volitional control electrical stimulation improves gait speed during the recovery stage in stroke patients. J Exerc Rehabil. 2019 Feb 25;15(1):95-102. doi: 10.12965/jer.1836500.250. eCollection 2019 Feb.
Background: PubMed 33386826da Rosa Pinheiro DR, Cabeleira MEP, da Campo LA, Correa PS, Blauth AHEG, Cechetti F. Effects of aerobic cycling training on mobility and functionality of acute stroke subjects: A randomized clinical trial. NeuroRehabilitation. 2021;48(1):39-47. doi: 10.3233/NRE-201585.
Background: PubMed 36186132Gonzalez-Rocha A, Mendez-Sanchez L, Ortiz-Rodriguez MA, Denova-Gutierrez E. Effect Of Exercise on Muscle Mass, Fat Mass, Bone Mass, Muscular Strength and Physical Performance in Community Dwelling Older Adults: Systematic Review and Meta-Analysis. Aging Dis. 2022 Oct 1;13(5):1421-1435. doi: 10.14336/AD.2022.0215. eCollection 2022 Oct 1.
Background: PubMed 38673621Shin J, Park E. Comparison between Discrete Multi-Wavelength Near-Infrared Spectroscopy and Bioelectrical Impedance Analysis in the Assessment of Muscle Mass for Community-Dwelling Older People. J Clin Med. 2024 Apr 18;13(8):2350. doi: 10.3390/jcm13082350.
Background: PubMed 31601831Menon RG, Raghavan P, Regatte RR. Quantifying muscle glycosaminoglycan levels in patients with post-stroke muscle stiffness using T1rho MRI. Sci Rep. 2019 Oct 10;9(1):14513. doi: 10.1038/s41598-019-50715-x.
Background: PubMed 24461239Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
Background: PubMed 39502116Choi AY, Lim JH, Kim BG. Effects of muscle strength exercise on muscle mass and muscle strength in patients with stroke: a systematic review and meta-analysis. J Exerc Rehabil. 2024 Oct 25;20(5):146-157. doi: 10.12965/jer.2448428.214. eCollection 2024 Oct.
Background: PubMed 39300491Hu MM, Wang S, Wu CQ, Li KP, Geng ZH, Xu GH, Dong L. Efficacy of robot-assisted gait training on lower extremity function in subacute stroke patients: a systematic review and meta-analysis. J Neuroeng Rehabil. 2024 Sep 19;21(1):165. doi: 10.1186/s12984-024-01463-1.
Background: PubMed 34247470Calafiore D, Negrini F, Tottoli N, Ferraro F, Ozyemisci-Taskiran O, de Sire A. Efficacy of robotic exoskeleton for gait rehabilitation in patients with subacute stroke : a systematic review. Eur J Phys Rehabil Med. 2022 Feb;58(1):1-8. doi: 10.23736/S1973-9087.21.06846-5. Epub 2021 Jul 12.
Background: PubMed 35741599Lorusso M, Tramontano M, Casciello M, Pece A, Smania N, Morone G, Tamburella F. Efficacy of Overground Robotic Gait Training on Balance in Stroke Survivors: A Systematic Review and Meta-Analysis. Brain Sci. 2022 May 31;12(6):713. doi: 10.3390/brainsci12060713.
Background: PubMed 32807486Su Y, Yuki M, Otsuki M. Prevalence of stroke-related sarcopenia: A systematic review and meta-analysis. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):105092. doi: 10.1016/j.jstrokecerebrovasdis.2020.105092. Epub 2020 Jul 3.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Seungwon Lee, PhD principal investigator

Sahmyook University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Overground Robot-Assisted Gait Training (o-RAGT) and Recumbent Bicycle Training in people with Stroke and Sarcopenia, run by Sahmyook University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Muscle Quality (time frame: Baseline and 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06910254, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.