NCT06910254Completed
Effects of Overground Robot-Assisted Gait Training on Stroke-Related Sarcopenia
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
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 53 (actual)
- First submitted
- 17 Mar 2025
- Start date
- 9 Jun 2025
- Primary completion date
- 21 Nov 2025
- Lead sponsor
- Sahmyook University
- Diseases
- Stroke
- NCT number
- NCT06910254
What you commit to
- Study type: Interventional
- Participants enrolled: 53
- From 9 Jun 2025 to the primary completion date, 21 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- \- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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.
Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sahmyook University Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.