Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07395544

Gait Training for Hemiplegic Stroke Patients With Stationary Trainer

This study aims to evaluate the effectiveness of a novel mobile neurodevelopmental treatment (NDT) gait training device for patients recovering from stroke. Stroke is a major cause of disability worldwide, and many survivors experience difficulty with walking and require long-term rehabilitation. NDT is a widely used rehabilitation approach that focuses on improving motor control through techniques such as facilitation, inhibition, and key point control. However, traditional NDT gait training can be physically demanding for therapists and often limits the training intensity and duration for patients.

To address these challenges, this study introduces an automated NDT gait training device that replicates therapist techniques using mechanical support and sensory feedback. The system uses bilateral dynamic assistance at the waist, auditory cues, and wearable inertial measurement units (IMUs) to help patients practice natural and symmetric walking patterns on the ground, instead of being restricted to treadmill training. The IMUs also provide objective gait data to assess improvement in gait symmetry, pelvic rotation, walking speed, and cadence.

The primary goal is to assess changes in these gait parameters before and after NDT-based intervention. The study plans to enroll 40 adult stroke survivors (aged 20 and older) over a 3-year period starting from May 1, 2024.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cheng Hsin General Hospital

Taipei, Beitou Dist., 112050, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 20 years, first-ever stroke, with Brunnstrom stage III to IV of the affected lower limb motor recovery.
  • Functional Ambulation Category (FAC) level IV.
  • Ability to ambulate on level ground without assistive devices.
  • Ability to understand instructions and cooperate with assessments.

Exclusion criteria

  • Presence of severe spinal cord injury or peripheral neuropathy.
  • Unstable gait requiring assistive devices, or participants at high risk of falling.
  • Severe impairment in vision, hearing, or cognition, making them unable to comply with assessments.
  • Lower limb fracture within the past 6 months.

Treatment and study plan

NDT Gait Training System

Device

The intervention includes a NDT gait training device that mimics therapist techniques through mechanical assistance, synchronized with auditory feedback and real-time gait analysis using IMU sensors.

Primary outcomes

  1. Pelvic rotation

    Time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).

    The gait parameter will be collected using wearable inertial measurement units (IMUs) before and after the NDT gait training intervention and pelvic rotation will be measured through axial angular velocity

  2. Walking speed

    Time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).

    Walking speed will be estimated from IMU during walking and reported in meters per second (m/s).

  3. Step length

    Time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training intervention).

    Step length will be derived from IMU-based spatiotemporal gait data collected during overground walking and reported in meters (m).

Sponsors and collaborators

Lead sponsor

Cheng-Hsin General Hospital

Other

Registry information

Official study title

Gait Training for Hemiplegic Stroke Patients: Employing a Stationary Neuro-developmental Trainer With Auditory Cues

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.