Hybrid foot‑pedal exoskeleton gait therapy with adjustable active assistance for people after chronic stroke
The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors
This test tries a new foot‑pedal exoskeleton (HIWIN MRG‑P110) with adjustable active assistance to see if it helps people 6 months to 3 years after a first stroke walk better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei, Taipei) |
| Trial ID | NCT07034521 on ClinicalTrials.gov |
What this trial studies
This interventional feasibility study uses the HIWIN MRG‑P110 end‑effector exoskeleton, which drives hip and knee movement via foot pedals and lets clinicians adjust how much active assistance the device provides. Adults 18–80 with a first-ever stroke 6 months to 3 years earlier and limited walking ability (FAC 0–3) will use the device for supervised gait training. The protocol focuses on usability measures and therapeutic outcomes such as gait and motor function changes while monitoring safety and tolerability. Participants who cannot fit the device or who have severe musculoskeletal or bone conditions are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults 18–80 who had a first stroke 6 months to 3 years ago, were independent walkers before the stroke, and currently have limited walking ability (FAC 0–3) but fit the device size and weight limits.
Not a fit: People with severe lower‑limb contractures or spasticity (Modified Ashworth Scale 4), significant musculoskeletal pain or wounds, severe osteoporosis or prior hip/spine fracture, or body size outside device limits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the device could improve walking ability and increase voluntary engagement in gait training for some people living with chronic stroke.
How similar studies have performed: Previous robot‑assisted gait studies have shown modest to meaningful walking gains for some stroke patients, but this specific end‑effector device with an adjustable active‑assist module is relatively new and less studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 0 (non-ambulatory) to level 3 (able to walk short distances indoors or outdoors only). * Prior to the current stroke, the participant was an independent community ambulator without mobility impairments. Exclusion Criteria: * 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 osteoporosis (T-score \< -2.5) or 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; Height \< 145 cm or \> 190 cm Thigh length \< 38 cm or \> 48 cm; Calf length \< 48 cm or \> 52 cm * Cognitive or communication impairments that prevent understanding of study instructions or completion of questionnaires. * 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, nasogastric tube, 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.
Where this trial is running
Taipei, Taipei
- National Taiwan University Hospital — Taipei, Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Dr. Chen
- Email: b00401020@ntu.edu.tw
- Phone: +886 23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.