Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gait assistance mode group | Experimental | Gait training is performed in gait assistance mode while wearing a hip-assist powered exoskeleton |
|
| Resistance mode | Experimental | Gait training is performed in Resistance mode while wearing a hip-assist powered exoskeleton |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gait assistance mode group | Device | A total of 10 sessions of gait training were performed using the hip-assist powered exoskeleton for 5 weeks (30 minutes per session) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 10 Meter Walk Test | (lower limb motor score in 10 Meter Walk test at post-intervention) - (lower limb motor score in 10 Meter Walk Test at baseline) Higher scores mean a better outcome | Baseline, after 5 intervention sessions(week 3) , and after 10 intervention sessions(Week 5) |
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
| Resistance mode | Device | A total of 10 sessions of gait training were performed using the hip-assist powered exoskeleton for 5 weeks (30 minutes per session) |
|