Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population

Launched by WANDERCRAFT · Jul 31, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a special robotic device called an exoskeleton can help adults with lower limb weakness. Many people, especially those who have had strokes or spinal cord injuries, struggle with walking and balance. The goal of the study is to provide a year-long rehabilitation program using the Atalante X exoskeleton, which participants will use at least once a week. Researchers want to understand how this therapy affects not just walking and balance, but also other aspects of life like cognitive function and overall well-being.

To join the study, participants need to be adults aged 18 or older who have lower limb weaknesses, regardless of the cause. They should be able to read and write in French and must agree to take part in the study by signing a consent form. However, some people won’t be eligible, such as those with severe muscle stiffness or certain health issues. Throughout the trial, participants will have their progress checked at different times to see how the rehabilitation is helping them. This study aims to provide valuable information about the long-term benefits of using exoskeletons for rehabilitation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient suffering from lower limb weaknesses and / or deficiencies regardless of the cause
• • Adult patient ≥18 years old
• • Patient able to read and write in French and who have signed an informed consent form
• • Patient affiliated to a social security system.
• Exclusion Criteria:
• • Individual with severe spasticity of adductor muscles, hamstring, quadriceps and triceps surae. Severe spasticity is defined by a score of 4 on the modified Ashworth scale
• • Pregnant woman
• • Individual with history of osteoporotic fracture and / or pathology or treatment causing secondary osteoporosis
• • Pressure Ulcer of Grade I or higher according to the NPUAP International Pressure Ulcer Classification System- EPUAP, in areas of contact with the Atalante X system
• • Severe aphasia limiting ability to express needs or to fulfil questionnaires, at the discretion of the physician.
• • Patient with a cardiac or respiratory contraindication to physical exertion, at discretion of the physician
• • Patient unable to deliver his/her consent
• • Patient under legal protection
• • Patient participating at the same time in another study
• • Patients with morphological contraindications to the use of the Atalante X exoskeleton (as per user's manual) with exceptions as follows: knee flessum of 20° authorized if sensibility is present; equinus of the ankle of 20° allowed regardless of presence or absence of sensibility, hip flessum of 20° allowed regardless of presence or absence of sensibility.