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Enrolling by invitation NCT07395544

Gait Training for Hemiplegic Stroke Patients With Stationary Trainer

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NDT Gait Training System.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device NDT Gait Training System
    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 outcome measures

  • Pelvic rotation [Time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).]
  • Walking speed [Time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).]
  • Step length [Time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training intervention).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Cheng Hsin General Hospital — Taipei

Identifiers

NCT: NCT07395544 · CHGH-(1069)112A-60

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗