Guillain Barré Syndrome, Paraplegia, Complete, Paraplegia, Incomplete, Spinal Cord Injury, Tetraplegia/Tetraparesis
Conditions
Keywords
Hands-free Exoskeleton, Atalante X, Atalante, Rehabilitation, Safety
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).
Interventions
DEVICEHands-free exoskeleton
Having undergone at least on session with Atalante exoskeleton. Clinical, safety and session data are collected retrospectively.
Sponsors
Wandercraft
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety through the collection of the reported adverse device effects | Baseline, up to 101 weeks. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Walking ability | Baseline, post-intervention (up to 101 weeks) | 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). |
| Walking speed | Baseline, post-intervention (up to 101 weeks) | This may involve 10 meters walk test (10MWT) measuring gait speed during a 10-meter walk during comfortable and rapid pace. |
| Mobility, balance, walking ability, and fall | Baseline, post-intervention (up to 101 weeks) | 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. |
| Spasticity assessment | Baseline, post-intervention (up to 101 weeks) | This may involve the use of the Modified Ashworth Scale or a general description of spasticity recorded in the medical file. |
| Balance | Baseline, post-intervention (up to 101 weeks) | This may involve Berg Balance Scale (BBS) including items include static and dynamic activities of varying difficulty. |
| Independance | Baseline, post-intervention (up to 101 weeks) | This may involve Spinal Cord Independence Measure (SCIM III) including items assessing self-care, respiration and sphincter management. |
| Usability assessment | Post-intervention (up to 101 weeks) | 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. |
| Endurance | Baseline, post-intervention (up to 101 weeks) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Descriptive data: Age | Baseline, up to 101 weeks. | To characterize the population, for each patient, the age will be collected when available (years). |
| Reasons for discontinuing sessions | Post-intervention (up to 101 weeks) | 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. |
| Descriptive data: Gender | Baseline, up to 101 weeks. | To characterize the population, for each patient, the gender will be collected when available (male, female). |
| Descriptive data: Cause and time since injury or pathology | Baseline, up to 101 weeks. | 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. |
| Descriptive data: Urinary status | Baseline, up to 101 weeks. | To characterize the population, for each patient, the urinary status will be collected when available: * Intermittent catherization * Indwelling catherization * External collection device * Other |
| Descriptive data: Bowel status | Baseline, up to 101 weeks. | To characterize the population, for each patient, the bowel status will be collected when available: * Digital stimulation * Manual evacuation * Colostomy * Other |
| Descriptive data: Severity of the lesion using the International Standards for Neurological Classification of SCI | Baseline, up to 101 weeks. | 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 |
| Descriptive data: Cardiorespiratory parameters | Baseline, up to 101 weeks. | 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. |
| Descriptive data: Pain | Baseline, up to 101 weeks. | 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). |
| Descriptive data: Bone health | Baseline, up to 101 weeks. | 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 |
Countries
France
Outcome results
None listed