Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07336667
Eligibility Criteria:
Inclusion Criteria:
* Adult patients with hemiplegia after stroke who are currently admitted to or visiting the rehabilitation therapy department of Seoul Brain Hospital in Yeongdeungpo-gu, Seoul, Republic of Korea.
* Chronic stage after stroke onset of at least 6 months.
* Diagnosis of unilateral hemiplegia.
* Mini-Mental State Examination(MMSE) score ≥ 24, with ability to understand the study procedures and provide informed consent.
* Functional Ambulation Catefories(FAC) score of 1-2(FAC 0 excluded.)
* Ability to communicate voluntarily for participation and consent.
* Suiable physical condition for robot-assisted gait training(RAGT) and use of Lokomat device, including body weight ≤ 135 kg and height between approximately 150 cm and 2.0 m.
Exclusion Criteria:
* MMSE score ≤ 23, indicating difficulty understanding the study procedures or expressing informed consent.
* History of major psychiatric disorders such as schizophrenia, major depressive disorder, or bipolar disorder.
* Uncontrolled cardiovascular or respiratory disease that makes gait training unsafe, such as uncontrolled hypertension, significant arrhythmia, angina, or acute exacerbation of respiratory disease.
* Orthopedic or neuromuscular conditions that prevent safe robotic gait training, including:
* Lower limb surgery or fracture within the previous 3 months.
* Moderate-to-severe joint contracture or severe spasticity (e.g., Modified Ashworth Scale ≥ 3).
* Clinically significant leg-length discrepancy (≥ 2 cm).
* Severe skin infection, pressure ulcer, or other skin condition at the harness or strap contact areas that makes physical contact difficult.
* Low back pain, dizziness, orthostatic hypotension, or other symptoms that prevent continuation of RAGT.
* Acute or recurrent neurological events within the previous 3 months (e.g., recurrent cerebrovascular events).
* Any other medical condition that the principal investigator judges to make participation unsafe.
Vulnerable Populations:
This study includes only adult participants and does not enroll legally vulnerable populations such as minors or pregnant women. For inpatients, potential reduction in voluntariness due to relationships with treating clinicians is minimized by obtaining consent from a non-treating researcher, allowing sufficient time for decision-making, permitting withdrawal at any time without penalty, and allowing a caregiver to be present during the consent process if desired.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT07336667
Study Brief:
Protocol Section:
NCT07336667