Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Sub… (NCT07353203) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Subacute and Chronic Stroke
South Korea32 participantsStarted 2025-10-28
Plain-language summary
The aim of this study is to evaluate the safety of gait training using a hip-assist powered exoskeleton. This will be assessed by collecting all device-related adverse events occurring during the entire intervention period, which consists of a total of 10 sessions within 5 weeks across two different gait rehabilitation protocols.
Who can participate
Age range19 Years – 85 Years
SexALL
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Inclusion criteria
✓. Adults aged 19 to 85 years.
✓. Patients with hemiplegia resulting from ischemic or hemorrhagic stroke.
✓. Patients in the late subacute or chronic phase, with stroke onset of 3 months or more (in cases of recurrent stroke, based on the most recent event). Functional Ambulation Category (FAC) score of 3 or higher.
✓. Patients capable of safely wearing the hip-assist powered exoskeleton and using it with minimal assistance.
✓. Patients who were capable of independent walking and had no disability in daily self-care activities prior to stroke onset (based on the last stroke for recurrent patients). (mRS ≤2)
✓. Patients who have received approval for study participation from the attending medical staff.
Exclusion criteria
✕. Severe cognitive impairment (Mini-Mental State Examination \[MMSE\] \< 10) or severe speech impairment/aphasia.
✕. History of major orthopedic surgery, such as hip, knee, or ankle arthroplasty, within the last 3 months.
✕. Fractures, open wounds, or unhealed ulcers in the lower extremities.
✕. Patients for whom gait training with the powered orthopedic device is difficult due to severe medical conditions, such as cardiovascular or pulmonary diseases.
✕. History of osteoporotic fractures.
What they're measuring
1
10 Meter Walk Test
Timeframe: Baseline, after 5 intervention sessions(week 3) , and after 10 intervention sessions(Week 5)