Evaluation of Usability and Safety of the System Atalante in Patients With High Paraplegia and Tetraplegia (QUATRO)

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).

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury; Tetraplegia/Tetraparesis; Paraplegia, Complete; Guillain Barré Syndrome; Paraplegia, Incomplete
• Intervention / Treatment: Device: Hands-free exoskeleton

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• France
  • Berck, France, 62600
    • Fondation Hopale
  • Pionsat, France, 63330
    • CMPR de Pionsat
  • Saint Sébastien de Morsent, France, 27180
    • Hôpital La Musse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population includes people with high paraplegia and tetraplegia.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hands-free exoskeleton; Patient with high paraplegia or tetraplegia who have undergone at least one session with the exoskeleton.	Device: Hands-free exoskeleton; Having undergone at least on session with Atalante exoskeleton. Clinical, safety and session data are collected retrospectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety through the collection of the reported adverse device effects	Measured through all reported adverse device effects (ADEs). ADEs are categorized into the following categories: musculoskeletal, cutaneous (skin abrasion), cardiovascular (orthostatic hypotension), pain, falls, and fractures and are further characterized as minor or serious based on the nature and the severity of the adverse event (AE).	Baseline, up to 101 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity assessment	This may involve the use of the Modified Ashworth Scale or a general description of spasticity recorded in the medical file.	Baseline, post-intervention (up to 101 weeks)
Walking ability	This may involve Walking Index for Spinal Cord Injury, version II (WISCI II) assessing the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from SCI. It ranges from 0 (unable to stand and/or participate in assisted walking) to 20 (ambulates with no devices, no braces and no physical assistance, 10 meters).	Baseline, post-intervention (up to 101 weeks)
Walking speed	This may involve 10 meters walk test (10MWT) measuring gait speed during a 10-meter walk during comfortable and rapid pace.	Baseline, post-intervention (up to 101 weeks)
Mobility, balance, walking ability, and fall	This may involve Time Up and Go (TUG), a timed task where the patient is asked to stand up from the chair, walk 3 meters, turn around, walk and sit again.	Baseline, post-intervention (up to 101 weeks)
Endurance	This may involve 6-minutes' walk test (6MWT) and 2-minutes' walk test (2MWT) measuring the walked distance during a 6- or 2-minutes' walk.	Baseline, post-intervention (up to 101 weeks)
Balance	This may involve Berg Balance Scale (BBS) including items include static and dynamic activities of varying difficulty.	Baseline, post-intervention (up to 101 weeks)
Independance	This may involve Spinal Cord Independence Measure (SCIM III) including items assessing self-care, respiration and sphincter management.	Baseline, post-intervention (up to 101 weeks)
Usability assessment	The assessment of the usability will be asked to the operators in charge of the rehabilitation of the patients included in this study. It includes a usability questionnaire and session data collection.	Post-intervention (up to 101 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive data: Age	To characterize the population, for each patient, the age will be collected when available (years).	Baseline, up to 101 weeks.
Descriptive data: Gender	To characterize the population, for each patient, the gender will be collected when available (male, female).	Baseline, up to 101 weeks.
Descriptive data: Cause and time since injury or pathology	To characterize the population, for each patient, the cause of injury or pathology, the time since injury or diagnosis (years) will be collected when available.	Baseline, up to 101 weeks.
Descriptive data: Urinary status	To characterize the population, for each patient, the urinary status will be collected when available: Intermittent catherization; Indwelling catherization; External collection device; Other	Baseline, up to 101 weeks.
Descriptive data: Bowel status	To characterize the population, for each patient, the bowel status will be collected when available: Digital stimulation; Manual evacuation; Colostomy; Other	Baseline, up to 101 weeks.
Descriptive data: Severity of the lesion using the International Standards for Neurological Classification of SCI	To characterize the population, for each patient, the following descriptive data will be collected when available: ASIA impairement scale: A (complete), B (sensory incomplete), C and D (motor incomplete), E (normal).; Neurological Level of Injury	Baseline, up to 101 weeks.
Descriptive data: Cardiorespiratory parameters	To characterize the population, for each patient, cardiorespiratory parameters including Heart Rate (HR) in Beats per minute and Blood Pressure (BP) in mmHg will be collected when available.	Baseline, up to 101 weeks.
Descriptive data: Pain	To characterize the population, for each patient, intensity of the pain using the subjective Numeric Pain Rating Scale (NPRS) will be collected when available: from 0 (no pain) to 10 (worst possible pain).	Baseline, up to 101 weeks.
Descriptive data: Bone health	To characterize the study population, bone health data will be collected for each patient, when available, including: T-score values ranging from 0 (normal) to below -2.5 (indicative of osteoporosis); Bone Mineral Density (BMD) measurements expressed in g/cm²	Baseline, up to 101 weeks.
Reasons for discontinuing sessions	The reason(s) for discontinuing sessions may include hospital discharge, patient's decision, pain or discomfort, achievement of goals set by the therapeutic team, etc.	Post-intervention (up to 101 weeks)

Collaborators and Investigators

• Sponsor: Wandercraft

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Safety; Atalante; Hands-free Exoskeleton; Atalante X
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Trauma, Nervous System; Spinal Cord Diseases; Polyneuropathies; Paralysis; Polyradiculoneuropathy; Spinal Cord Injuries; Quadriplegia; Paraplegia; Guillain-Barre Syndrome
• Other Study ID Numbers: CIP009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No