Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke

Launched by FONDAZIONE DON CARLO GNOCCHI ONLUS · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how hybrid robotics can help people who have had a stroke improve their walking abilities. After a stroke, many individuals experience weakness on one side of their body, which can make it difficult to walk. The trial aims to test a combination of robotic assistance and electrical stimulation of the muscles to see if these methods can support better movement and lead to long-term recovery.

To participate in this study, individuals must be at least 18 years old and have had their first stroke at least two weeks prior. They should also be able to stand without support for a minute and meet certain height and weight requirements. However, people with certain medical conditions, like severe cognitive impairments or significant joint issues, will not be eligible to join. Those who participate can expect to work with advanced robotic devices during their rehabilitation, which could help improve their mobility and overall quality of life after a stroke.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years or older
• • Diagnosis of first unilateral ischemic or hemorrhagic ictus, at least two weeks from the event, ischemic or hemorrhagic
• • diagnosis confermed with Computer Tomography or Magnetic Resonance Imaging
• • 1 ≤ FAC (Functional ambulation category) ≤ 3
• • 50 kg ≤ weight ≤ 90 kg
• • 150 cm ≤ height ≤ 192 cm
• • Femor length: 355-475 mm
• • Tibia length: 405-485 mm
• • Pelvic width 690-990 mm
• • shoe size 36-45
• • Capable of standing unsupported for at least one minute
• Exclusion Criteria:
• • Mini Mental State Examination score (corrected for age and education) \< 24
• • Clinical evidence in the medical records of visuospatial and ideomotor apraxia, behavioral disorders, neglect, severe visual and auditory sensory disorders or those which prevent use of the device
• • patients at risk of fractures or with strategic fractures (unstabilized fractures or spinal instability)
• • Major head trauma
• • Subarachnoid hemorrhage, cerebral thrombosis
• • Cardio-respiratory or internal clinical instability
• • Pregnant or breastfeeding status;
• • Recent malignant neoplasm
• • Chronic inflammatory diseases with joint involvement of the lower limbs;
• • Severe spasticity (Ashworth\>3)
• • Significant limitations in passive ROM of the hips and knees
• • Problems with the integrity of the skin at the interface surfaces with the device or which would prevent sitting.
• • Implanted electronic devices
• • Epilepsy
• • Severe peripheral neuropathies