NCT07087743

Brief Summary

This study evaluates a novel Virtual Reality (VR)-integrated visual feedback system designed to enhance limb propulsion during robot-assisted gait rehabilitation in individuals post-stroke. In collaboration with CUREXO, a rehabilitation robotics company, the system is embedded within the Morning Walk® end-effector robot and provides real-time visual feedback to facilitate symmetrical use of the paretic and non-paretic limbs. The goal is to address gait asymmetry commonly observed in hemiparetic stroke survivors by promoting improved paretic leg propulsion, which is a key contributor to forward movement during walking. A total of 30 participants (15 stroke, 15 healthy controls) aged 20 years or older will undergo single-session gait training using the VR-robot system. Participants will be assessed using spatiotemporal gait parameters, muscle activity, foot pressure, and vertical ground reaction forces. Additional safety measures-including a saddle-type weight support and real-time heart rate monitoring via smartwatch-are implemented to ensure a safe and controlled training environment. This study aims to test the feasibility and effectiveness of this VR-based system in improving gait symmetry and functional walking capacity in people recovering from stroke.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
7mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

July 9, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

July 25, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2026

Expected
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

July 9, 2025

Last Update Submit

March 31, 2026

Conditions

Keywords

Propulsion FeedbackGait RehabilitationParetic LegVirtual RealityEnd-Effector Robot

Outcome Measures

Primary Outcomes (1)

  • Change in Spatiotemporal Gait Symmetry using the Zeno Walkway GaitMat

    Spatiotemporal gait parameters will be collected using the Zeno Walkway GaitMat before and after a single session of VR-based gait training. Gait spatiotemporal parameters will be calculated from the ratio of step lengths (paretic/non-paretic in stroke group; left/right in healthy group). The step length will be compared pre- and post-training.

    Baseline (pre-training) and immediately post-training (same session)

Secondary Outcomes (2)

  • Change in Peak Propulsive Force (Paretic vs. Non-Paretic Limb)

    Baseline and immediately post-training (same session)

  • Change in Lower Extremity Muscle Activity

    Baseline and immediately post-training (same session)

Study Arms (2)

Post-Stroke Group

EXPERIMENTAL

Individuals who have had a stroke will complete a single session of VR-integrated gait training using the Morning Walk® end-effector robot. Gait performance will be evaluated before and after training.

Behavioral: VR-Based Gait Training with End-Effector Robot

Healthy Group

EXPERIMENTAL

Healthy participants will undergo the same single-session VR-integrated gait training using the Morning Walk® end-effector robot. Pre- and post-training assessments will be conducted.

Behavioral: VR-Based Gait Training with End-Effector Robot

Interventions

A single-session gait training protocol using the Morning Walk® end-effector robot with real-time virtual reality visual feedback to encourage paretic limb propulsion and symmetrical gait. This intervention is intended to study participants' behavioral and biomechanical responses to the VR feedback, not to evaluate the robot as a device.

Healthy GroupPost-Stroke Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 20 years or older.
  • For post-stroke participants:
  • Diagnosis of stroke at least 1 month prior to participation.
  • Able to walk at least 10 meters with or without assistive devices.
  • For healthy participants:
  • ° Must walk independently without assistive devices.

You may not qualify if:

  • Individuals with a life expectancy of less than one year.
  • Comatose individuals.
  • Individuals unable to follow three-step commands.
  • Individuals with lower limb amputation.
  • Individuals with poorly controlled diabetes (e.g., foot ulceration).
  • Individuals with legal blindness.
  • Individuals with progressive neurological conditions.
  • Medically unstable individuals.
  • Individuals with significant musculoskeletal impairments.
  • Individuals with congestive heart failure or unstable angina.
  • Individuals with peripheral vascular disease.
  • Individuals with severe neuropsychiatric disorders (e.g., dementia, cognitive deficits, or severe depression).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Mansoo Ko, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: This is a mixed design study with two distinct populations: individuals post-stroke and healthy controls. All participants undergo a single session of VR-based gait training with an end-effector robot. Pre- and post-intervention measures are collected to evaluate within-subject changes and between-group differences.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 28, 2025

Study Start

July 25, 2025

Primary Completion (Estimated)

December 27, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations