Gait Training for Hemiplegic Stroke Patients With Stationary Trainer

NCT07395544 | Enrolling By Invitation DMC

• 1 other identifier: CHGH-(1069)112A-60
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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).

Study Arms (1)

NDT gait training group

EXPERIMENTAL

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

Interventions

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.

NDT gait training group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cheng-Hsin General Hospital: lead

Study Sites (1)

Cheng Hsin General Hospital

Taipei, Beitou Dist., 112050, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Szu-Fu Chen, MD, PhD

  Cheng-Hsin General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this study, inertial measurement units are used for gait phase detection and as feedback parameters for the system. Previous studies have validated the reliability and accuracy of IMU data compared to those collected in motion analysis laboratories.

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: February 9, 2026
• Study Start: May 2, 2024
• Primary Completion: December 5, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)