StrokeNCT07336667
The Effect of Robot-Assisted Gait Training With or Without Plantar Pressure Summary Feedback: Impact on Gait Symmetry and Balance in Hemiplegic Patients
A study testing Lokomat robot assisted gait training and Plantar pressure summary feedback in people with Stroke and Hemiplegia, run by Yeonji Choi at 1 site in South Korea.
Trial summary
The goal of this randomized, single-blind clinical trial is to learn whether a 4-week Lokomat-based gait training program with plantar pressure feedback can improve gait symmetry and balance in adult patients with chronic hemiplegic stroke. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Lokomat robot assisted gait training and Plantar pressure summary feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Feb 2026to 1 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with hemiplegia after stroke who are currently admitted to or visiting the rehabilitation therapy department of Seoul Brain Hospital in Yeongdeungpo-gu, Seoul, Republic of Korea.
- Chronic stage after stroke onset of at least 6 months.
- Diagnosis of unilateral hemiplegia.
- Mini-Mental State Examination(MMSE) score ≥ 24, with ability to understand the study procedures and provide informed consent.
- Functional Ambulation Catefories(FAC) score of 1-2(FAC 0 excluded.)
- Ability to communicate voluntarily for participation and consent.
- Suiable physical condition for robot-assisted gait training(RAGT) and use of Lokomat device, including body weight ≤ 135 kg and height between approximately 150 cm and 2.0 m.
Who cannot join
- MMSE score ≤ 23, indicating difficulty understanding the study procedures or expressing informed consent.
- History of major psychiatric disorders such as schizophrenia, major depressive disorder, or bipolar disorder.
- Uncontrolled cardiovascular or respiratory disease that makes gait training unsafe, such as uncontrolled hypertension, significant arrhythmia, angina, or acute exacerbation of respiratory disease.
- Orthopedic or neuromuscular conditions that prevent safe robotic gait training, including:
- Lower limb surgery or fracture within the previous 3 months.
- Moderate-to-severe joint contracture or severe spasticity (e.g., Modified Ashworth Scale ≥ 3).
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- Clinically significant leg-length discrepancy (≥ 2 cm).
- Severe skin infection, pressure ulcer, or other skin condition at the harness or strap contact areas that makes physical contact difficult.
- Low back pain, dizziness, orthostatic hypotension, or other symptoms that prevent continuation of RAGT.
- Acute or recurrent neurological events within the previous 3 months (e.g., recurrent cerebrovascular events).
- Any other medical condition that the principal investigator judges to make participation unsafe.
- Vulnerable Populations:
- This study includes only adult participants and does not enroll legally vulnerable populations such as minors or pregnant women. For inpatients, potential reduction in voluntariness due to relationships with treating clinicians is minimized by obtaining consent from a non-treating researcher, allowing sufficient time for decision-making, permitting withdrawal at any time without penalty, and allowing a caregiver to be present during the consent process if desired.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Duksoo Medical Foundation Seoul Brain Hospital
Seoul, Seoul, 07301
About this study
Official title: 족저압 요약 피드백 제공 유무에 따른 로봇보조보행훈련의 효과: 편마비 환자의 보행 대칭성과 균형에 미치는 영향; The Effect of Robot-Assisted Gait Training With or Without Plantar Pressure Summary Feedback: Impact on Gait Symmetry and Balance in Hemiplegic Patients
The goal of this randomized, single-blind clinical trial is to learn whether a 4-week Lokomat-based gait training program with plantar pressure feedback can improve gait symmetry and balance in adult patients with chronic hemiplegic stroke. The main questions it aims to answer are:
Does Lokomat training with plantar pressure feedback improve spatiotemporal gait symmetry, as measured with the GAITRite system, more than Lokomat training without plantar pressure feedback? Does this intervention lead to greater improvements in balance and walking speed, assessed by the Berg Balance Scale (BBS) and the 10-Meter Walk Test (10MWT), compared with conventional Lokomat training? Researchers will compare a group receiving Lokomat training with both real-time feedback and additional summary plantar pressure feedback to a group receiving Lokomat training with real-time feedback only, to see if adding plantar pressure feedback results in superior gains in gait symmetry, balance, and walking ability.
Participants will be adult inpatients with chronic hemiplegic stroke. They will be randomly assigned to one of the two training groups and will receive Lokomat-based gait training three times per week for 30 minutes per session over four weeks. Before and after the intervention period, participants will undergo gait analysis using the GAITRite walkway and clinical assessments including the BBS and 10MWT.
- Conditions
- Stroke, Hemiplegia
- Being tested
- Lokomat robot assisted gait training, Plantar pressure summary feedback
- Keywords
- Chronic hemiplegic stroke, robot assisted gait training, Lokomat, GaitRite, Plantar pressure feedback
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lokomat robot assisted gait trainingDevice
Lokomat robot assisted gait training for 30 minutes per session, 3 times per week, for 4 weeks. Real-time(biofeedback graph) visual and auditory feedback provided by the Lokomat system is used during gait training in both groups.
Plantar pressure summary feedbackOther
Experimental group, plantar pressure data are collected during each Lokomat session using instrumented insoles. After each session, session by session plantar pressure summary feed back and gait symmetry is provided to the participant to promote more symmetrical gait. The control group does not receive this plantar summary feedback.
| Study group | Role | What they receive |
|---|---|---|
| Lokomat with plantar pressure summary feedback | Experimental | Participants receive 30 minute Lokomat(robot-assisted gait training) with real-time feedback plus additional plantar pressure summary feedback. Training is provided 3 times per week for 4 weeks. Balance and gait symmetry are assessed before and after the intervention Receives: Device: Lokomat robot assisted gait training; Other: Plantar pressure summary feedback |
| Real-time feedback(biofeedback program) | Active comparator | Participants receive 30 minute Lokomat(robot-assisted gait training) training with real-time feedback only. Training is provided 3 times per week for 4 weeks. Balance and gait symmetry are assessed before and after the intervention. Receives: Device: Lokomat robot assisted gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait symmetry(GaitRite)
Measured: Change from baseline to 4 weeks after randomization(end of intervention)
Change in gait symmetry(10-meter walk test)
Measured: Change from baseline to 4 weeks after randomization(end of intervention)
Secondary outcomes (2)
Change in balance performance(Berg Balance Test)
Measured: Change from baseline to 4 weeks after randomization(end of intervention)
Change in balance performance(Timed Up and Go test)
Measured: Change from baseline to 4 weeks after randomization(end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start5 Feb 2026
- Primary completion29 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeonji Choi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yeonji Choi, Sahmyook University
- Investigators
- seongwon Lee, PhD, PT, Principal investigator, Sahmyook University, Department of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336667
- Sponsor's protocol ID
- 2025-08-026-003
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 족저압 요약 피드백 제공 유무에 따른 로봇보조보행훈련의 효과: 편마비 환자의 보행 대칭성과 균형에 미치는 영향; The Effect of Robot-Assisted Gait Training With or Without Plantar Pressure Summary Feedback: Impact on Gait Symmetry and Balance in Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT07336667
- Acronym / sponsor ID
- 2025-08-026-003
- Conditions
- Stroke, Hemiplegia
- Keywords
- Chronic hemiplegic stroke, robot assisted gait training, Lokomat, GaitRite, Plantar pressure feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yeonji ChoiUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 13 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 goal of this randomized, single-blind clinical trial is to learn whether a 4-week Lokomat-based gait training program with plantar pressure feedback can improve gait symmetry and balance in adult patients with chronic hemiplegic stroke. The main questions it aims to answer are:
Does Lokomat training with plantar pressure feedback improve spatiotemporal gait symmetry, as measured with the GAITRite system, more than Lokomat training without plantar pressure feedback? Does this intervention lead to greater improvements in balance and walking speed, assessed by the Berg Balance Scale (BBS) and the 10-Meter Walk Test (10MWT), compared with conventional Lokomat training? Researchers will compare a group receiving Lokomat training with both real-time feedback and additional summary plantar pressure feedback to a group receiving Lokomat training with real-time feedback only, to see if adding plantar pressure feedback results in superior gains in gait symmetry, balance, and walking ability.
Participants will be adult inpatients with chronic hemiplegic stroke. They will be randomly assigned to one of the two training groups and will receive Lokomat-based gait training three times per week for 30 minutes per session over four weeks. Before and after the intervention period, participants will undergo gait analysis using the GAITRite walkway and clinical assessments including the BBS and 10MWT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lokomat with plantar pressure summary feedback | Experimental | Device: Lokomat robot assisted gait training, Other: Plantar pressure summary feedbackParticipants receive 30 minute Lokomat(robot-assisted gait training) with real-time feedback plus additional plantar pressure summary feedback. Training is provided 3 times per week for 4 weeks. Balance and gait symmetry are assessed before and after the intervention |
| Real-time feedback(biofeedback program) | Active comparator | Device: Lokomat robot assisted gait trainingParticipants receive 30 minute Lokomat(robot-assisted gait training) training with real-time feedback only. Training is provided 3 times per week for 4 weeks. Balance and gait symmetry are assessed before and after the intervention. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients with hemiplegia after stroke who are currently admitted to or visiting the rehabilitation therapy department of Seoul Brain Hospital in Yeongdeungpo-gu, Seoul, Republic of Korea.
- Chronic stage after stroke onset of at least 6 months.
- Diagnosis of unilateral hemiplegia.
- Mini-Mental State Examination(MMSE) score ≥ 24, with ability to understand the study procedures and provide informed consent.
- Functional Ambulation Catefories(FAC) score of 1-2(FAC 0 excluded.)
Key exclusion criteria (13 listed)
- MMSE score ≤ 23, indicating difficulty understanding the study procedures or expressing informed consent.
- History of major psychiatric disorders such as schizophrenia, major depressive disorder, or bipolar disorder.
- Uncontrolled cardiovascular or respiratory disease that makes gait training unsafe, such as uncontrolled hypertension, significant arrhythmia, angina, or acute exacerbation of respiratory disease.
- Orthopedic or neuromuscular conditions that prevent safe robotic gait training, including:
- Lower limb surgery or fracture within the previous 3 months.
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 |
|---|---|---|
| Lokomat robot assisted gait trainingLokomat robot assisted gait training for 30 minutes per session, 3 times per week, for 4 weeks. Real-time(biofeedback graph) visual and auditory feedback provided by the Lokomat system is used during gait training in both groups. | Device | Lokomat with plantar pressure summary feedback, Real-time feedback(biofeedback program) |
| Plantar pressure summary feedbackExperimental group, plantar pressure data are collected during each Lokomat session using instrumented insoles. After each session, session by session plantar pressure summary feed back and gait symmetry is provided to the participant to promote more symmetrical gait. The control group does not receive this plantar summary feedback. | Other | Lokomat with plantar pressure summary feedback |
Primary outcome
Change in gait symmetry(GaitRite)
Time frame: Change from baseline to 4 weeks after randomization(end of intervention)
Change in gait symmetry(10-meter walk test)
Time frame: Change from baseline to 4 weeks after randomization(end of intervention)
2 secondary outcomes
Change in balance performance(Berg Balance Test)
Time frame: Change from baseline to 4 weeks after randomization(end of intervention)
Change in balance performance(Timed Up and Go test)
Time frame: Change from baseline to 4 weeks after randomization(end of intervention)
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 16 Jul 2026.
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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.
seongwon Lee, PhD, PT principal investigator
Sahmyook University, Department of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lokomat robot assisted gait training and Plantar pressure summary feedback in people with Stroke and Hemiplegia, run by Yeonji Choi 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 7 inclusion and 13 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 16 Jul 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?
Change in gait symmetry(GaitRite) (time frame: Change from baseline to 4 weeks after randomization(end of intervention)). The study lists 2 primary outcomes in all. 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 16 Jul 2026.