Gait Training for Hemiplegic Stroke Patients With Stationary Trainer

Cheng-Hsin General Hospital

Status: Invitation-only

Conditions: Stroke

Treatments: Device: NDT Gait Training System

Study type: Interventional

Funder types: Other

Identifiers

NCT07395544

CHGH-(1069)112A-60

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

NDT gait training group

Experimental group

Description:

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).

Treatment:

Device: NDT Gait Training System