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

Wandercraft

Status

Enrolling

Conditions

Cerebrovascular Accident

Spinal Cord Injuries

Gait Disorders, Neurologic

Motor Disorders

Neurodegenerative Diseases

Weakness, Muscle

Treatments

Device: Hands-free exoskeleton

Study type

Interventional

Funder types

Industry

Identifiers

NCT06538974

CIP005 ALERT

Details and patient eligibility

About

In 2019, approximately 2.4 billion people worldwide required rehabilitation for various health pathologies, a 63% increase since 1990. It has been suggested that current rehabilitation frameworks (inpatient, outpatient, and community-based) are insufficient to meet local population needs due to issues like long waiting times, lack of facilities, prioritization, funding, and accessibility.Patients with lower limb weaknesses, resulting from various conditions (for example stroke, traumatic brain injury, spinal cord injury and others) require long-term management and motivation for engagement, which are crucial for functional outcomes. This highlights the need for sustainable gait and balance rehabilitation.

New technologies like exoskeletons have shown promising results in short-term inpatient programs, improving gait, balance, and quality of life, however, long-term follow-up data are still needed.

The present clinical investigation is a national, prospective, open-label interventional trial, proposing a 12-month outpatient rehabilitation program with the Atalante X exoskeleton to treat lower limb weakness and/or impairments in 100 participants. The rehabilitation program consists of at least one exoskeleton rehabilitation session per week. At the end of the first-year experimental phase, participants can continue for an additional year in the voluntary phase. The program aims to explore the potential long-term effects of supervised robotic rehabilitation on motor, cognitive, bowel, bladder functions, quality of life, and well-being. Assessments are conducted at baseline, after 4 and 12 months of exoskeleton rehabilitation, and at 16 and 24 months for participants in the voluntary phase.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.