Effects of Overground Robot-Assisted Gait Training on Stroke-Related Sarcopenia
NCT ID: NCT06910254
Last Updated: 2026-01-14
Study Results
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Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2025-06-09
2025-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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).
TREATMENT
SINGLE
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.
Study Groups
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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).
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.
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.
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).
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion 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
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.
19 Years
80 Years
ALL
No
Sponsors
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Sahmyook University
OTHER
Responsible Party
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Dong min park
Principal Investigator, Clinical physical therapist
Principal Investigators
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Seungwon Lee, PhD
Role: PRINCIPAL_INVESTIGATOR
Sahmyook University
Locations
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Sahmyook University
Seoul, , South Korea
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SYU 2025-01-010-004
Identifier Type: -
Identifier Source: org_study_id
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