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

NCT06910254 | Completed

• 1 other identifier: SYU 2025-01-010-001
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

subacute stroke; sarcopenia; Overground Robot-Assisted Gait Training (o-RAGT); Robotic rehabilitation; Muscle Quality; Skeletal muscle mass; Falls Efficacy; Exoskeleton Robot

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  Baseline and 4 weeks

Secondary Outcomes (5)

• Change in Short Physical Performance Battery (SPPB) Score

  Baseline and 4 weeks

• Change in Timed Up and Go Test (TUG)

  Baseline and 4 weeks

• Change in Fugl-Meyer Assessment (FMA) Lower Extremity Score

  Baseline and 4 weeks

• Change in 6-Minute Walk Test (6MWT)

  Baseline and 4 weeks

• Change in Handgrip Strength

  Baseline and 4 weeks

Study Arms (2)

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).

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).

Device: Recumbent Bicycle Training

Interventions

Overground Robot-Assisted Gait Training (o-RAGT) DEVICE

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.

Also known as: Angel Legs M20 wearable exoskeleton

o-RAGT + Recumbent Bicycle Training

Recumbent Bicycle Training DEVICE

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.

Also known as: Recumbent ergometer

Recumbent Bicycle Training Only; o-RAGT + Recumbent Bicycle Training

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria:
• Diagnosis of stroke within 6 months of onset (subacute phase), corresponding to the active neurological recovery period.
• 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).
• 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.
• Functional Ambulation Category (FAC) score ≥1, indicating the ability to attempt ambulation with at least minimal assistance.
• Korean version of the Mini-Mental State Examination (MMSE-K) score ≥24, indicating sufficient cognitive ability to understand instructions and participate in training.
• Currently admitted for inpatient rehabilitation at a rehabilitation hospital in Seoul, Republic of Korea.
• Ability and willingness to provide written informed consent after receiving a full explanation of the study procedures, potential risks, and benefits.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Sahmyook University: lead

Study Sites (1)

Sahmyook University

Seoul, 01795, South Korea

Location

Related Publications (14)

• 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.

  PMID: 24307968 BACKGROUND

• 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.

  PMID: 30899743 BACKGROUND

• 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.

  PMID: 33386826 BACKGROUND

• 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.

  PMID: 36186132 BACKGROUND

• 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.

  PMID: 38673621 BACKGROUND

• 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.

  PMID: 31601831 BACKGROUND

• 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.

  PMID: 24461239 BACKGROUND

• 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.

  PMID: 39502116 BACKGROUND

• 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.

  PMID: 39300491 BACKGROUND

• 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.

  PMID: 34247470 BACKGROUND

• 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.

  PMID: 35741599 BACKGROUND

• 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.

  PMID: 32807486 BACKGROUND

• 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.

  PMID: 31992219 BACKGROUND

• 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.

  PMID: 21475676 RESULT

MeSH Terms

Conditions

Stroke; Sarcopenia; Muscular Atrophy; Mobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Seungwon Lee, PhD

  Sahmyook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study employed a single-blind design. Due to the nature of the interventions, participants and therapists delivering the overground robot-assisted gait training and recumbent bicycle training could not be blinded to group allocation. However, outcome assessors were blinded to group assignments throughout the study. All primary and secondary outcome assessments were performed by assessors who were not involved in the intervention delivery and had no access to the randomization information during data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical physical therapist

Model Details: 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).

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 4, 2025
• Study Start: June 9, 2025
• Primary Completion: November 21, 2025
• Study Completion: November 30, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)