NCT07087769

Brief Summary

This single-session study aims to evaluate a novel gait training protocol that integrates mechanical constraints and sensory feedback to enhance paretic leg propulsion in individuals post-stroke. The study will include 15 individuals who have experienced a stroke and 15 healthy adults, each aged 20 years or older. Participants will walk on both tied-belt and split-belt treadmills under various training conditions, including backward-directed resistance (applied at the pelvis, ankle, or both) and real-time sensory feedback (visual, auditory, or combined). These interventions will be applied individually and in combination to identify the most effective environment for promoting symmetrical gait patterns. Each session will last approximately two hours. The equipment used is non-invasive, and the risk to participants is minimal.

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
6mo 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 Progress58%
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
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 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

Outcome Measures

Primary Outcomes (1)

  • Change in Paretic Leg Propulsive Force

    Peak anterior ground reaction force of the paretic leg will be measured using an instrumented split-belt treadmill . Changes in propulsive force under different treadmill and resistance/feedback conditions will be analyzed to evaluate improvements in gait symmetry.

    Within a single session (approximately 2 hours)

Secondary Outcomes (10)

  • Muscle Activity of Lower Extremity During Treadmill and overgrouun Walking

    Day 1 (during treadmill and overground walking trials)

  • Step Length (m) During Overground Walking Using Zeno Walkway

    Day 1 (during overground walking trials)

  • Hip Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System

    Day 1 (during treadmill walking trials)

  • Walking Speed (m/s) During Overground Walking Using Zeno Walkway

    Day 1 (during overground walking trials)

  • Cadence (steps/min) During Overground Walking Using Zeno Walkway

    Day 1 (during overground walking trials)

  • +5 more secondary outcomes

Study Arms (1)

Gait Training with Combined Sensory Feedback and Mechanical Constraints

EXPERIMENTAL

All participants will receive various gait training conditions during a single session. Conditions include treadmill walking (tied-belt and split-belt), backward-directed resistance (applied at pelvis, ankle, or both), sensory feedback (visual, auditory, or combined), and a final combined condition integrating both resistance and feedback. This is a within-subject crossover design.

Behavioral: Treadmill Walking with Split-Belt and/or Tied-Belt ConditionsBehavioral: Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacityBehavioral: Sensory Feedback Training

Interventions

Participants will walk on an instrumented treadmill under split-belt and/or tied-belt conditions depending on their walking capacity. The belt speeds will be adjusted to facilitate locomotor adaptation and evaluate propulsion symmetry.

Gait Training with Combined Sensory Feedback and Mechanical Constraints

Participants will walk on a treadmill (Split-belt and/or Tied-belt) with backward-directed resistance applied at the pelvis, ankle, or both. The resistance is used to challenge paretic leg propulsion and assess adaptive gait responses.

Gait Training with Combined Sensory Feedback and Mechanical Constraints

Real-time feedback-visual, auditory, or combined-will be provided based on the propulsive force generated during split-belt and/or tied-belt treadmill walking, with or without mechanical resistance.

Gait Training with Combined Sensory Feedback and Mechanical Constraints

Eligibility Criteria

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

You may qualify if:

  • Aged 20 years or older
  • For stroke group: clinical diagnosis of stroke at least 1 month prior to participation
  • Ability to walk at least 10 meters with or without assistive devices
  • For healthy group: able to walk independently without assistive devices

You may not qualify if:

  • Life expectancy less than one year
  • Comatose or unable to follow three-step commands
  • Amputation of any lower limb
  • Poorly controlled diabetes (e.g., foot ulceration)
  • Blindness
  • Progressive neurological disease
  • Medically unstable condition
  • Significant musculoskeletal impairments affecting gait
  • Congestive heart failure or unstable angina
  • Peripheral vascular disease
  • Severe neuropsychiatric conditions (e.g., dementia, cognitive deficits, 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
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Participants will undergo multiple gait training conditions in a single session, including combinations of treadmill walking (tied-belt and split-belt), backward resistance (pelvis, ankle, or both), and sensory feedback (visual, auditory, or combined). All participants will receive all conditions in a within-subject crossover design.
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 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations