Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Subacute and Chronic Stroke

NCT07353203 | Completed

• 1 other identifier: 2025-08-147
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Stroke; Exoskeleton; Subacute Stroke

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

gait assistance mode group

EXPERIMENTAL

Gait training is performed in gait assistance mode while wearing a hip-assist powered exoskeleton

Device: gait assistance mode group

Resistance mode

EXPERIMENTAL

Gait training is performed in Resistance mode while wearing a hip-assist powered exoskeleton

Device: Resistance mode

Interventions

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)

gait assistance mode group

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)

Resistance mode

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with other neurological diseases affecting gait (e.g., Parkinson's disease, multiple sclerosis, etc.).
• Any other cases where the investigator deems participation in the study to be inappropriate.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 20, 2026
• Study Start: October 28, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

KR (1)