StrokeNCT07411703
Automated Trainer-Based Gait Rehabilitation for Hemiplegic Stroke Patients
An observational study of Stroke, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
Trial summary
This study aims to evaluate the effectiveness of an automated mobile gait training device developed based on neurodevelopmental treatment (NDT) principles for patients with hemiplegic stroke. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- NDT Gait Training System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Mar 2025to 26 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult stroke survivors with hemiplegia
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Gait Training for Hemiplegic Stroke Patients: Employing an Automated Trainer With Sensory Cues
This study aims to evaluate the effectiveness of an automated mobile gait training device developed based on neurodevelopmental treatment (NDT) principles for patients with hemiplegic stroke. Stroke is a major cause of long-term disability, and many survivors experience impaired walking ability that affects their independence and daily functioning. NDT is a commonly used rehabilitation approach that emphasizes therapist-guided facilitation of normal movement patterns during gait training. However, conventional NDT gait training is physically demanding and time-consuming for therapists, which may limit the amount of repetitive gait practice patients can receive.
To address these limitations, this study introduces a power-assisted gait training device capable of reproducing key therapeutic interventions typically provided by therapists. The system uses synchronized dynamic assistance, auditory cues, and wearable inertial measurement units (IMUs) to support gait training on the ground and facilitate more natural and repetitive walking practice. The IMUs provide objective gait data that are used to evaluate changes in swing-phase symmetry, pelvic rotation amplitude, and walking speed.
The primary goal of this study is to assess changes in these gait parameters following training with the proposed NDT-based assistive device. The study plans to enroll 60 adult stroke survivors (aged 20 and older) over a 3-year period starting from March 26, 2025.
- Conditions
- Stroke
- Being tested
- NDT Gait Training System
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDT Gait Training SystemDevice
The intervention consists of an NDT gait training device that replicates therapist-applied techniques through mechanical assistance, combined with synchronized auditory feedback and real-time gait analysis using IMU sensors.
What is being measured
The primary outcome is the main question the study is designed to answer.
Swing phase asymmetry
Swing-phase asymmetry, defined as the difference in swing-phase proportion between the non-paretic and paretic limbs- will be calculated from toe-off to heel-strike timing within the gait cycle, using the wearable inertial measurement units (IMUs) before and after the NDT gait training intervention .
Measured: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Pelvic rotation amplitude
Gait data will be acquired via wearable IMUs before and after the NDT gait training intervention, and the amplitude of pelvic rotation will be derived from axial angular velocity data.
Measured: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Walking speed
Walking speed will be quantified during gait using IMU-based measurements, and the average walking speed for each stage will be computed from recorded motor-driven motion data and reported in meters per second (m/s).
Measured: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start26 Mar 2025
- Primary completion26 Mar 2028 (estimated)
- Study completion26 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Szu-Fu Chen, Principal investigator, MD, PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411703
- Sponsor's protocol ID
- CHGH-(1140)113-70
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Training for Hemiplegic Stroke Patients: Employing an Automated Trainer With Sensory Cues
- ClinicalTrials.gov ID
- NCT07411703
- Acronym / sponsor ID
- CHGH-(1140)113-70
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 26 Mar 2028 (estimated)
- Study completion
- 26 Mar 2029 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of an automated mobile gait training device developed based on neurodevelopmental treatment (NDT) principles for patients with hemiplegic stroke. Stroke is a major cause of long-term disability, and many survivors experience impaired walking ability that affects their independence and daily functioning. NDT is a commonly used rehabilitation approach that emphasizes therapist-guided facilitation of normal movement patterns during gait training. However, conventional NDT gait training is physically demanding and time-consuming for therapists, which may limit the amount of repetitive gait practice patients can receive.
To address these limitations, this study introduces a power-assisted gait training device capable of reproducing key therapeutic interventions typically provided by therapists. The system uses synchronized dynamic assistance, auditory cues, and wearable inertial measurement units (IMUs) to support gait training on the ground and facilitate more natural and repetitive walking practice. The IMUs provide objective gait data that are used to evaluate changes in swing-phase symmetry, pelvic rotation amplitude, and walking speed.
The primary goal of this study is to assess changes in these gait parameters following training with the proposed NDT-based assistive device. The study plans to enroll 60 adult stroke survivors (aged 20 and older) over a 3-year period starting from March 26, 2025.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult stroke survivors with hemiplegia
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NDT Gait Training SystemThe intervention consists of an NDT gait training device that replicates therapist-applied techniques through mechanical assistance, combined with synchronized auditory feedback and real-time gait analysis using IMU sensors. | Device | – |
Primary outcome
Swing phase asymmetry
Time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Swing-phase asymmetry, defined as the difference in swing-phase proportion between the non-paretic and paretic limbs- will be calculated from toe-off to heel-strike timing within the gait cycle, using the wearable inertial measurement units (IMUs) before and after the NDT gait training intervention .
Pelvic rotation amplitude
Time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Gait data will be acquired via wearable IMUs before and after the NDT gait training intervention, and the amplitude of pelvic rotation will be derived from axial angular velocity data.
Walking speed
Time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Walking speed will be quantified during gait using IMU-based measurements, and the average walking speed for each stage will be computed from recorded motor-driven motion data and reported in meters per second (m/s).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Szu-Fu Chen principal investigator
MD, PhD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swing phase asymmetry (time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.