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The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors

RecruitingNAAges 18 Years - 80 YearsAllNational Taiwan University Hospital
NCT07034521 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 g

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📋 Eligibility rules (as published)
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.
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What it tests

  • HIWIN MRG-P110
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Where

1 site
National Taiwan University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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