Actively Recruiting
The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors
Led by National Taiwan University Hospital · Updated on 2026-05-19
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Walking rehabilitation after a stroke is most effective within the first three months, but many patients beyond six months can still improve their walking ability. Researchers are studying a new end-effector exoskeleton robot system called HIWIN MRG-P110 to see how usable and effective it is for gait training in patients who are 6 months to 3 years post-stroke. This randomized, single-blind study will enroll 60 stroke survivors with limited walking ability to test this new device. Participants will be randomly assigned to one of two groups: an active-assistive mode group, where the robot helps but encourages voluntary movement, or a fully passive mode group, where the robot moves the legs without active assistance. Both groups will receive 15 treatment sessions over 5 weeks using the HIWIN MRG-P110 device. The study will compare improvements in walking and balance as well as brain activity changes measured by functional near-infrared spectroscopy. During the study, participants will complete walking tests before treatment, immediately after the last session, and again 3 months later. Researchers will assess gait, balance, and brain function to evaluate the robot's effects. Participants must attend all treatment sessions and follow-up assessments. The study lasts about 3 months, including treatment and follow-up, with careful monitoring of safety and progress throughout.
CONDITIONS
Brief Title
The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 80 years old.
- First-ever stroke confirmed by brain CT or MRI, with onset between 6 months and 3 years before enrollment.
- Walking ability classified as Functional Ambulation Category level 1 to 3.
- Independent community ambulator without mobility impairments prior to current stroke.
You will not qualify if you...
- 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 difference (>2 cm after orthotic correction).
- History of osteoporotic fractures in thoracolumbar spine or hip joints.
- Unable to use the exoskeleton device due to body size: body weight >135 kg; thigh length <36 cm or >48 cm; calf length <42 cm or >58 cm.
- Cognitive or communication impairments preventing understanding or questionnaire completion.
- Acute infections or unstable vital signs.
- Significant orthostatic hypotension or inability to maintain upright posture over 30 minutes.
- Use of indwelling urinary catheter or tracheostomy.
- Pregnant women.
- Terminal illness with life expectancy under six months.
- Unable to attend all 15 rehabilitation sessions and 3-month follow-up assessment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 sessions
Participants receive robot-assisted gait training using the HIWIN MRG-P110 device in either passive or active-assistive mode.
15 rehabilitation sessions
Duration - 3 months
Participants are assessed for therapeutic effects and recovery after completing the intervention.
1 visit approximately 3 months after intervention
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taipei, Taiwan
Actively Recruiting
Research Team
D
Dr. Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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