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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hands-free exoskeleton | Patient with high paraplegia or tetraplegia who have undergone at least one session with the exoskeleton. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hands-free exoskeleton | Device | Having undergone at least on session with Atalante exoskeleton. Clinical, safety and session data are collected retrospectively. |
|
| 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. |
| 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 |
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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The population includes people with high paraplegia and tetraplegia.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondation Hopale | Berck | France | 62600 | France | ||
| CMPR de Pionsat |
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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) |
| 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:
| Baseline, up to 101 weeks. |
| Descriptive data: Bowel status | To characterize the population, for each patient, the bowel status will be collected when available:
| 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:
| 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:
| 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) |
| Pionsat |
| France |
| 63330 |
| France |
| Hôpital La Musse | Saint-Sébastien-de-Morsent | France | 27180 | France |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D011782 | Quadriplegia |
| D010264 | Paraplegia |
| D020275 | Guillain-Barre Syndrome |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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