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Search / Trial NCT06910254

Robot-Assisted Gait and Bicycle Training for Stroke Patients With Pre-Sarcopenia

Launched by SAHMYOOK UNIVERSITY · Apr 1, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Stroke Induced Sarcopenia Muscle Strength Robotic Exoskeletons Resistance Training Muscle Composition Muscle Quality

ClinConnect Summary

This clinical trial is studying how two types of training—robot-assisted walking and recumbent bicycle exercise—can help stroke survivors who are experiencing early muscle loss, a condition known as pre-sarcopenia. The goal is to see if these training methods can improve muscle strength, physical abilities, and help prevent falls in patients who are still recovering from a stroke that happened within the last six months. Participants will be divided into two groups; one will do both types of training, while the other will do just the bicycle exercises. The training sessions will take place five times a week for four weeks.

To join this study, participants need to be at least 19 years old, have recently had a stroke, and show early signs of muscle loss. They should also be able to follow simple instructions and walk with some assistance. However, individuals with severe cognitive issues, certain medical conditions, or major mobility problems will not be eligible. This trial aims to develop better rehabilitation strategies to enhance recovery and safety for stroke patients dealing with muscle weakness.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Participants must meet all of the following criteria:
  • 1. Subacute stroke patients within 6 months of onset.
  • 2. Height between 140 and 190 cm, and body weight ≤ 80 kg.
  • 3. Functional Ambulation Category (FAC) score ≥ 1, indicating minimal assistance required for walking.
  • 4. Mini-Mental State Examination (MMSE) score ≥ 24, indicating no more than mild cognitive impairment.
  • 5. 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:
  • 1. Serious cardiovascular conditions (e.g., heart failure, myocardial infarction) or acute medical issues preventing intervention.
  • 2. Musculoskeletal impairments that prevent the use of robotic equipment or recumbent bicycle training (e.g., fractures, joint replacements, severe lower limb deformities).
  • 3. Severe language impairment, poor cooperation, or psychological/psychiatric conditions making evaluation difficult.
  • 4. Previous exposure to robot-assisted gait training or similar interventions within the last 6 months.

About Sahmyook University

Sahmyook University is a distinguished academic institution based in South Korea, renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, the university leverages its extensive expertise in health sciences and innovative research methodologies to facilitate high-quality clinical studies. Sahmyook University aims to contribute to the development of effective therapeutic interventions and enhance patient care through rigorous clinical trials that adhere to ethical standards and regulatory guidelines. By fostering collaboration among researchers, healthcare professionals, and industry partners, the university is dedicated to translating scientific discoveries into practical applications for improved health outcomes.

Locations

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Seungwon Lee, PhD

Principal Investigator

Sahmyook University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported