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

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of robot-assisted walking therapy for people who have had a stroke more than six months ago and still have difficulty walking. The robot uses foot pedals to help move the hips and knees, and it can adjust how much it actively helps, encouraging patients to use their own muscles as much as possible. The goal is to see if this new robot training can improve walking and balance better than a fully passive mode, and to understand how the brain responds to this type of therapy.

People between 18 and 80 years old who had their first stroke 6 months to 3 years ago and have limited walking ability (from not walking at all to walking short distances indoors or outdoors) may be eligible. Participants will take part in 15 therapy sessions over 5 weeks, using either the active-assistive robot mode or a fully passive mode. The study will check improvements right after the treatment and again after 3 months. It is important that participants can follow instructions, attend all sessions, and meet certain physical requirements to use the robot safely. This study could offer new hope for people in the later stages of stroke recovery who want to improve their walking.

Gender

ALL

Eligibility 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.