NCT07353203Completed
Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Subacute and Chronic Stroke
Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Subacute and Chronic Stroke, Multi-center, Randomized Controlled Pilot Study
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 32 (actual)
- First submitted
- 5 Dec 2025
- Start date
- 28 Oct 2025
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Samsung Medical Center
- Diseases
- Stroke
- NCT number
- NCT07353203
What you commit to
- Study type: Interventional
- Participants enrolled: 32
- From 28 Oct 2025 to the primary completion date, 28 Feb 2026
- 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.
Other illness
- 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.
- 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.
- Patients with other neurological diseases affecting gait (e.g., Parkinson's disease, multiple sclerosis, etc.).
Other
- Fractures, open wounds, or unhealed ulcers in the lower extremities.
- Any other cases where the investigator deems participation in the study to be inappropriate.
Who the study is looking for
- 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.
- Height: 140 cm - 190 cm
- Weight: 80 kg or less
- 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.
Age in the registry: 19 years to 85 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 |
|---|---|---|---|
| Samsung Medical Center 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.