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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Stroke; Subacute Stroke; Exoskeleton
• Intervention / Treatment: Device: gait assistance mode group; Device: Resistance mode

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults aged 19 to 85 years.
2. Patients with hemiplegia resulting from ischemic or hemorrhagic stroke.
3. 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.

4. 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
5. 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)
6. Patients who have received approval for study participation from the attending medical staff.

Exclusion Criteria:

1. Severe cognitive impairment (Mini-Mental State Examination [MMSE] < 10) or severe speech impairment/aphasia.
2. History of major orthopedic surgery, such as hip, knee, or ankle arthroplasty, within the last 3 months.
3. Fractures, open wounds, or unhealed ulcers in the lower extremities.
4. Patients for whom gait training with the powered orthopedic device is difficult due to severe medical conditions, such as cardiovascular or pulmonary diseases.
5. History of osteoporotic fractures.
6. Patients with other neurological diseases affecting gait (e.g., Parkinson's disease, multiple sclerosis, etc.).
7. Any other cases where the investigator deems participation in the study to be inappropriate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gait assistance mode group; Gait training is performed in gait assistance mode while wearing a hip-assist powered exoskeleton	Device: gait assistance mode group; A total of 10 sessions of gait training were performed using the hip-assist powered exoskeleton for 5 weeks (30 minutes per session)
Experimental: Resistance mode; Gait training is performed in Resistance mode while wearing a hip-assist powered exoskeleton	Device: Resistance mode; A total of 10 sessions of gait training were performed using the hip-assist powered exoskeleton for 5 weeks (30 minutes per session)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2025
• Primary Completion (Actual): February 28, 2026
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-08-147

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No