Stroke
Conditions
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.
Interventions
DEVICENDT 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.
Sponsors
Cheng-Hsin General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic rotation | 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 |
| Walking speed | 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). |
| Step length | 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). |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORSzu-Fu Chen, MD, PhD
Cheng-Hsin General Hospital
Outcome results
None listed