Chronic Strokebrain disorderNCT07353203
Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Subacute and Chronic Stroke
A study testing gait assistance mode group and Resistance mode in people with Chronic Stroke and Subacute Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Chronic Stroke, Subacute Stroke, Exoskeleton
- What is being tested?
- gait assistance mode group and Resistance mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Oct 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Stroke, Subacute Stroke, Exoskeleton
- Being tested
- gait assistance mode group, Resistance mode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait assistance mode groupDevice
A total of 10 sessions of gait training were performed using the hip-assist powered exoskeleton for 5 weeks (30 minutes per session)
Resistance modeDevice
A total of 10 sessions of gait training were performed using the hip-assist powered exoskeleton for 5 weeks (30 minutes per session)
| Study group | Role | What they receive |
|---|---|---|
| gait assistance mode group | Experimental | Gait training is performed in gait assistance mode while wearing a hip-assist powered exoskeleton Receives: Device: gait assistance mode group |
| Resistance mode | Experimental | Gait training is performed in Resistance mode while wearing a hip-assist powered exoskeleton Receives: Device: Resistance mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, after 5 intervention sessions(week 3) , and after 10 intervention sessions(Week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start28 Oct 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Hyuk Chang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353203
- Sponsor's protocol ID
- 2025-08-147
- Acronym
- brain disorder
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07353203
- Acronym / sponsor ID
- brain disorder / 2025-08-147
- Conditions
- Chronic Stroke, Subacute Stroke, Exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gait assistance mode group | Experimental | Device: gait assistance mode groupGait training is performed in gait assistance mode while wearing a hip-assist powered exoskeleton |
| Resistance mode | Experimental | Device: Resistance modeGait training is performed in Resistance mode while wearing a hip-assist powered exoskeleton |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gait assistance mode groupA total of 10 sessions of gait training were performed using the hip-assist powered exoskeleton for 5 weeks (30 minutes per session) | Device | gait assistance mode group |
| Resistance modeA total of 10 sessions of gait training were performed using the hip-assist powered exoskeleton for 5 weeks (30 minutes per session) | Device | Resistance mode |
Primary outcome
10 Meter Walk Test
Time frame: Baseline, after 5 intervention sessions(week 3) , and after 10 intervention sessions(Week 5)
(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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
Related trials for Chronic Stroke
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Recruiting
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Stroke, Ischemic, Chronic Stroke
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Not yet recruiting
Proof-of-concept for Use of Transcutaneous Spinal Stimulation (TSS) With the ExaStim® Stimulation System in Adults With Chronic Ischemic Stroke
Chronic Stroke, Ischemic Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gait assistance mode group and Resistance mode in people with Chronic Stroke and Subacute Stroke, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 Meter Walk Test (time frame: Baseline, after 5 intervention sessions(week 3) , and after 10 intervention sessions(Week 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.