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.
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.
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
Single group
Hands-free exoskeleton
DeviceDuring the one-year intervention period, participants will complete at least one exoskeleton session per week (≥36 sessions) with the Atalante X. The additional voluntary year follows the same design. During sessions with the exoskeleton, the patients will perform ambulatory exercises with the device, with a gradual increase of intensity through the sessions.
Function in Sitting Test
The Function in Sitting Test consists of 14 items, each scored on a scale from 0 to 4, where 0 indicates the lowest ability and 4 represents normal sitting abilities. The maximum achievable score is 56, reflecting normal ability.
10-meter walk test
Gait speed during 10 meter walk
Modified Clinical Test of Sensory Integration in Balance
Modified Clinical Test of Sensory Integration in Balance test evaluates how different sensory inputs contribute to balance control by assessing balance tasks performed under different sensory conditions: eyes open, firm surface; eyes closed, firm surface; eyes open, foam surface; and eyes closed, foam surface. Scores are based on the time the participant can maintain balance (0-30 seconds for each task, with the maximum score being 120 seconds for all tasks, higher scores reflecting good sensory integration and balance control).
Timed Up and Go
Timed Up and Go is a timed task where patient is asked to stand up from the chair, walk 3 meters, turn around, walk and sit again. Based on established thresholds in the literature for various pathologies, the test helps determine if the participant is at risk of falling.
Functional Independence Measure
Functional Independence Measure scale score measures the level of disability and the amount of assistance required for an individual to perform activities of daily living. The total score ranges from 18 to 126, with higher scores indicating greater independence.
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