Clinical trial NCT06939634: Evaluation of Usability and Safety of the System Atalante in Patients With High Paraplegia and Tetraplegia
Official title: Evaluation of Usability and Safety of the System Atalante in Patients With High Paraplegia and Tetraplegia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Tetraplegia/Tetraparesis
Paraplegia, Complete
Paraplegia, Incomplete
Guillain Barré Syndrome
Keywords: Hands-free Exoskeleton
Atalante X
Atalante
Rehabilitation
Safety
Lead sponsor: Wandercraft
Sponsor class: INDUSTRY
First posted: 2025-04-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population includes people with high paraplegia and tetraplegia.

Brief summary: The objective of this clinical trial is to determine whether the Atalante X exoskeleton can be safely utilized by patients with tetraplegia and high paraplegia (at or above T4).


Eligibility criteria: Inclusion Criteria:

* ≥18 years old,
* Tetraplegia or high paraplegia (at or above T4) regardless of the cause,
* Non-opposition to the participation to the study,
* Having undergone a minimum of 1 session with the Atalante device from February 2019, to now.

Exclusion Criteria:

* Neurological Level of Injury below T4 as determined by the International Standards for Neurological Classification of SCI

Primary outcomes:
measure: Safety through the collection of the reported adverse device effects
timeFrame: Baseline, up to 101 weeks.
Secondary outcomes:
measure: Spasticity assessment
timeFrame: Baseline, post-intervention (up to 101 weeks)
measure: Walking ability
timeFrame: Baseline, post-intervention (up to 101 weeks)
measure: Walking speed
timeFrame: Baseline, post-intervention (up to 101 weeks)
measure: Mobility, balance, walking ability, and fall
timeFrame: Baseline, post-intervention (up to 101 weeks)
measure: Endurance
timeFrame: Baseline, post-intervention (up to 101 weeks)
measure: Balance
timeFrame: Baseline, post-intervention (up to 101 weeks)
measure: Independance
timeFrame: Baseline, post-intervention (up to 101 weeks)
measure: Usability assessment
timeFrame: Post-intervention (up to 101 weeks)
Other outcomes:
measure: Descriptive data: Age
timeFrame: Baseline, up to 101 weeks.
measure: Descriptive data: Gender
timeFrame: Baseline, up to 101 weeks.
measure: Descriptive data: Cause and time since injury or pathology
timeFrame: Baseline, up to 101 weeks.
measure: Descriptive data: Urinary status
timeFrame: Baseline, up to 101 weeks.
measure: Descriptive data: Bowel status
timeFrame: Baseline, up to 101 weeks.
measure: Descriptive data: Severity of the lesion using the International Standards for Neurological Classification of SCI
timeFrame: Baseline, up to 101 weeks.
measure: Descriptive data: Cardiorespiratory parameters
timeFrame: Baseline, up to 101 weeks.
measure: Descriptive data: Pain
timeFrame: Baseline, up to 101 weeks.
measure: Descriptive data: Bone health
timeFrame: Baseline, up to 101 weeks.
measure: Reasons for discontinuing sessions
timeFrame: Post-intervention (up to 101 weeks)
Locations:
city: Berck
country: France
facility: Fondation Hopale
city: Pionsat
country: France
facility: CMPR de Pionsat
city: Saint Sébastien de Morsent
country: France
facility: Hôpital La Musse
Study officials:
References: