The Effect of Robot-Assisted Gait Training With or Without Plantar Pressure Summary Feedback: Impact on Gait Symmetry and Balance in Hemiplegic Patients

April 23, 2026 updated by: Yeonji Choi

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 07301
        • Duksoo Medical Foundation Seoul Brain Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lokomat with plantar pressure summary feedback
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
Device: Lokomat robot assisted gait training
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.
Other: Plantar pressure summary feedback
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.
Active Comparator: Real-time feedback(biofeedback program)
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.
Device: Lokomat robot assisted gait training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in gait symmetry(GaitRite)
Time Frame: Change from baseline to 4 weeks after randomization(end of intervention)
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)
Change from baseline to 4 weeks after randomization(end of intervention)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in balance performance(Berg Balance Test)
Time Frame: Change from baseline to 4 weeks after randomization(end of intervention)
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)
Change from baseline to 4 weeks after randomization(end of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeonji Choi

Investigators

  • Principal Investigator: seongwon Lee, PhD, PT, Sahmyook University, Department of Physical Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Estimated)

April 29, 2026

Study Completion (Estimated)

April 29, 2026

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-08-026-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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