Using exoskeletons for long-term rehabilitation of lower limb weakness

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

This study is testing whether a hands-free exoskeleton can help adults with lower limb weakness from conditions like stroke or spinal cord injury improve their walking, balance, and quality of life over time.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wandercraft (industry)
• Locations: 1 site (Paris)
• Trial ID: NCT06538974 on ClinicalTrials.gov

What this trial studies

This clinical investigation focuses on the use of a hands-free exoskeleton, the Atalante X, to provide long-term rehabilitation for adults suffering from lower limb weaknesses due to various conditions such as stroke or spinal cord injury. The study aims to assess the effectiveness of this technology in improving gait, balance, and overall quality of life over an extended period. Participants will engage in a structured rehabilitation program that emphasizes sustained motivation and management of their conditions. The study is designed to gather long-term follow-up data to address the current gaps in rehabilitation frameworks.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who experience lower limb weaknesses or deficiencies, regardless of the underlying cause.

Not a fit: Patients with severe spasticity, significant cardiac or respiratory issues, or those who cannot engage with the rehabilitation process due to severe aphasia may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the rehabilitation outcomes for patients with lower limb deficiencies, leading to improved mobility and quality of life.

How similar studies have performed: While exoskeletons have shown promise in short-term rehabilitation settings, long-term data on their effectiveness in outpatient settings is still limited, making this approach relatively novel.

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.

Where this trial is running

Paris

• Wandercraft — Paris, France (RECRUITING)

Study contacts

• Principal investigator: Rebecca Sauvagnac, MD — Wandercraft
• Study coordinator: Rebecca Sauvagnac, MD

Conditions: Motor Disorders, Gait Disorders, Neurologic, Neurodegenerative Diseases, Spinal Cord Injuries, Weakness, Muscle, Cerebrovascular Accident, Hands-free Exoskeleton, Atalante X