Hybrid foot‑pedal exoskeleton gait therapy with adjustable active assistance for people after chronic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 1 to level 3.
* 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 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.
* 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.

Where it's running

• National Taiwan University Hospital
  Taipei, Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Dr. Chen
• Email: b00401020@ntu.edu.tw
• Phone: +886 23123456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.