Gait Training for Hemiplegic Stroke Patients With Stationary Trainer

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke
• Intervention / Treatment: Device: NDT Gait Training System

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Beitou Dist.
    • Taipei, Beitou Dist., Taiwan, 112050
      • Cheng Hsin General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NDT gait training group; NDT gait trainer which can automatically repeat NDT intervention, thereby alleviating therapists' workload and extending patients' training time. They analyzed therapists' intervention in manual NDT training and concluded that therapists cued subjects' anterior superior iliac spines (ASISs) when perceiving opposite heel strikes (HSs).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic rotation	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	Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Walking speed	Walking speed will be estimated from IMU during walking and reported in meters per second (m/s).	Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Step length	Step length will be derived from IMU-based spatiotemporal gait data collected during overground walking and reported in meters (m).	Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training intervention).

Collaborators and Investigators

• Sponsor: Cheng-Hsin General Hospital
• Investigators: Principal Investigator: Szu-Fu Chen, MD, PhD, Cheng-Hsin General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Actual): December 5, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 17, 2025
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: CHGH-(1069)112A-60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No