Status:
RECRUITING
Robot-Assisted Gait and Bicycle Training for Stroke Patients With Pre-Sarcopenia
Lead Sponsor:
Sahmyook University
Conditions:
Stroke
Sarcopenia in Elderly
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
This study aims to evaluate the effects of overground robot-assisted gait training (o-RAGT) using a wearable robotic exoskeleton (Angel Legs M20) combined with recumbent cycling on muscle mass, physic...
Detailed Description
Stroke is a leading cause of long-term disability worldwide, with many survivors experiencing difficulties in walking and functional mobility. In the early phase of recovery (subacute stage), patients...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participants must meet all of the following criteria:
- Subacute stroke patients within 6 months of onset.
- Height between 140 and 190 cm, and body weight ≤ 80 kg.
- Functional Ambulation Category (FAC) score ≥ 1, indicating minimal assistance required for walking.
- Mini-Mental State Examination (MMSE) score ≥ 24, indicating no more than mild cognitive impairment.
- Diagnosed with pre-sarcopenia based on the Korean version of the SARC-F questionnaire (score ≥ 4) and low skeletal muscle mass according to the Asian Working Group for Sarcopenia (AWGS 2019) criteria.
- Exclusion Criteria
- Participants will be excluded if they meet any of the following conditions:
- Serious cardiovascular conditions (e.g., heart failure, myocardial infarction) or acute medical issues preventing intervention.
- Musculoskeletal impairments that prevent the use of robotic equipment or recumbent bicycle training (e.g., fractures, joint replacements, severe lower limb deformities).
- Severe language impairment, poor cooperation, or psychological/psychiatric conditions making evaluation difficult.
- Previous exposure to robot-assisted gait training or similar interventions within the last 6 months.
Exclusion
Key Trial Info
Start Date :
June 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06910254
Start Date
June 9 2025
End Date
August 31 2025
Last Update
July 10 2025
Active Locations (1)
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1
Sahmyook University
Seoul, South Korea, 01795