StrokeNCT07034521
The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors
A study testing HIWIN MRG-P110 in people with Stroke and Rehabilitation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Walking rehabilitation after stroke is most effective during the first three months of recovery, but even in the chronic phase-beyond six months post-stroke-a significant number of patients still show potential for gait improvement. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Rehabilitation, Robotic Rehabilitation
- What is being tested?
- HIWIN MRG-P110
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Aug 2025to May 2028
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years old.
- First-ever stroke, confirmed by brain CT or MRI, with onset between 6 months and 3 years prior to enrollment.
- Walking ability classified as Functional Ambulation Category (FAC) level 1 to level 3.
- Prior to the current stroke, the participant was an independent community ambulator without mobility impairments.
Who cannot join
- Presence of lower limb joint contractures, deformities, or severe spasticity (Modified Ashworth Scale score of 4).
- Lower limb musculoskeletal conditions causing wounds, pain, inability to bear weight, or significant leg length discrepancy (>2 cm after orthotic correction).
- Known history of osteoporotic fractures in the thoracolumbar spine or hip joints.
- Inability to use the exoskeleton device due to body size, including:
- Body weight > 135 kg; Thigh length < 36 cm or > 48 cm; Calf length < 42 cm or > 58 cm
- Cognitive or communication impairments that prevent understanding of study instructions or completion of questionnaires.
Show all 12Show fewer
- Acute infections or unstable vital signs.
- Significant orthostatic hypotension or inability to maintain upright posture for more than 30 minutes.
- Use of indwelling urinary catheter or tracheostomy.
- Pregnant women.
- Terminal illness with life expectancy less than six months.
- Inability to attend 15 rehabilitation sessions and follow-up assessment at 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taipei
Dr. Chen, +88623123456 ext. 267887, b00401020@ntu.edu.tw
About this study
Walking rehabilitation after stroke is most effective during the first three months of recovery, but even in the chronic phase-beyond six months post-stroke-a significant number of patients still show potential for gait improvement. Robot-assisted rehabilitation is becoming increasingly common in clinical settings, with various design modes available. However, the effectiveness of new products in improving gait or motor function still requires further investigation.
This study aims to evaluate the usability and therapeutic effects of a new end-effector exoskeleton robot system, HIWIN MRG-P110, for gait training in chronic stroke patients. The system uses foot pedal mechanisms to drive hip and knee movements for lower-limb training. Unlike its predecessor, this device allows adjustment of the active assistance ratio, encouraging users to engage in voluntary movement. It is designed for gait training in stroke patients and others with neurological impairments, but the usability and efficacy of this new training model remain to be verified.
Read more
This clinical trial is a randomized, single-blind, prospective study enrolling 60 stroke patients who are 6 months to 3 years post-onset and have a Functional Ambulation Category (FAC) level of 0 to 3. The study will explore how patients with varying degrees of motor weakness learn to adapt to the "active-assistive mode" in terms of speed and perception. Participants will be randomly assigned to either the active-assistive mode group or the fully passive mode group. Both groups will receive 15 treatment sessions over 5 weeks.
The study will compare the two groups in terms of:
- Improvements in gait and balance immediately post-treatment and at 3-month follow-up
- Changes in brain activity, as measured by functional near-infrared spectroscopy (fNIRS)
- Conditions
- Stroke, Rehabilitation, Robotic Rehabilitation
- Being tested
- HIWIN MRG-P110
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIWIN MRG-P110Device
HIWIN MRG-P110 is a robotics for lower limbs rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| passive mode | Active comparator | Not described Receives: Device: HIWIN MRG-P110 |
| active-assistive mode | Active comparator | Not described Receives: Device: HIWIN MRG-P110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meter walk test
Measured: baseline, right after last session of intervension (within 1 week), 3 months after intervension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start12 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completionMay 2028 (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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034521
- Sponsor's protocol ID
- 202504096DSE
- Status last verified
- May 2026
- First submitted
- 11 Jun 2025
- Last updated
- 19 May 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT07034521
- Acronym / sponsor ID
- 202504096DSE
- Conditions
- Stroke, Rehabilitation, Robotic Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 24 Jun 2025 (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.
Walking rehabilitation after stroke is most effective during the first three months of recovery, but even in the chronic phase-beyond six months post-stroke-a significant number of patients still show potential for gait improvement. Robot-assisted rehabilitation is becoming increasingly common in clinical settings, with various design modes available. However, the effectiveness of new products in improving gait or motor function still requires further investigation.
This study aims to evaluate the usability and therapeutic effects of a new end-effector exoskeleton robot system, HIWIN MRG-P110, for gait training in chronic stroke patients. The system uses foot pedal mechanisms to drive hip and knee movements for lower-limb training. Unlike its predecessor, this device allows adjustment of the active assistance ratio, encouraging users to engage in voluntary movement. It is designed for gait training in stroke patients and others with neurological impairments, but the usability and efficacy of this new training model remain to be verified.
This clinical trial is a randomized, single-blind, prospective study enrolling 60 stroke patients who are 6 months to 3 years post-onset and have a Functional Ambulation Category (FAC) level of 0 to 3. The study will explore how patients with varying degrees of motor weakness learn to adapt to the "active-assistive mode" in terms of speed and perception. Participants will be randomly assigned to either the active-assistive mode group or the fully passive mode group. Both groups will receive 15 treatment sessions over 5 weeks.
The study will compare the two groups in terms of:
- Improvements in gait and balance immediately post-treatment and at 3-month follow-up
- Changes in brain activity, as measured by functional near-infrared spectroscopy (fNIRS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| passive mode | Active comparator | Device: HIWIN MRG-P110 |
| active-assistive mode | Active comparator | Device: HIWIN MRG-P110 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 80 years old.
- First-ever stroke, confirmed by brain CT or MRI, with onset between 6 months and 3 years prior to enrollment.
- Walking ability classified as Functional Ambulation Category (FAC) level 1 to level 3.
- Prior to the current stroke, the participant was an independent community ambulator without mobility impairments.
Key exclusion criteria (12 listed)
- Presence of lower limb joint contractures, deformities, or severe spasticity (Modified Ashworth Scale score of 4).
- Lower limb musculoskeletal conditions causing wounds, pain, inability to bear weight, or significant leg length discrepancy (>2 cm after orthotic correction).
- Known history of osteoporotic fractures in the thoracolumbar spine or hip joints.
- Inability to use the exoskeleton device due to body size, including:
- Body weight > 135 kg; Thigh length < 36 cm or > 48 cm; Calf length < 42 cm or > 58 cm
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 |
|---|---|---|
| HIWIN MRG-P110HIWIN MRG-P110 is a robotics for lower limbs rehabilitation | Device | active-assistive mode, passive mode |
Primary outcome
10 meter walk test
Time frame: baseline, right after last session of intervension (within 1 week), 3 months after intervension
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 19 May 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIWIN MRG-P110 in people with Stroke and Rehabilitation, run by National Taiwan University 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 12 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: looking for participants now, as of the sponsor's last update on 19 May 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?
Contact Dr. Chen (+886 23123456 ext. 267887, b00401020@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meter walk test (time frame: baseline, right after last session of intervension (within 1 week), 3 months after intervension). 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 19 May 2026.