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| Name | Class |
|---|---|
| Hospital Nacional de Parapléjicos de Toledo | OTHER |
| Fundación del Lesionado Medular | UNKNOWN |
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The goal of this clinical trial is to analyze the usability and safety of the robotic gait ATLAS 2030 in a cohort of pediatric patients with Spinal Cord Injury, with the aim of extending its indication for use to pediatric spinal cord injury
Spinal cord injury has a relatively low prevalence in the pediatric population, although its effects have significant physical and psychological consequences that greatly impact the quality of life of affected children. The ATLAS 2030 exoskeleton is a robotic gait device approved by the Spanish Agency of Medicines and Medical Devices for the rehabilitation of pediatric patients with cerebral palsy and spinal muscular atrophy. The principal aim is to analyze the safety and usability of the ATLAS 2030 exoskeleton during the implementation of a robotic gait training program with this device in a cohort of pediatric patients with spinal cord injury. the secondary aim is to analyze, in the same cohort of pediatric patients with spinal cord injury and through the implementation of the same therapeutic program, the efficacy of the ATLAS 2030 exoskeleton in improving fatigability, mood, health perception, and gait speed.
Ten sessions with the ATLAS 2030 exoskeleton will be conducted with pediatric patients with acute or chronic spinal cord injury. Additionally, two assessment sessions will be performed before and after the series of sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot Asissted Gait Training | Experimental | The rehabilitation sessions will be carried out by a physiotherapist trained in rehabilitation with the ATLAS 2030 exoskeleton |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation treatment with ATLAS2030 | Device | 10 sessions of Rehabilitation Treatment with ATLAS2030 with With an evaluation session before the first session and another one after 10 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | occurrence of any serious adverse event to the participant | From enrollment to the last assessment session at 8 weeks |
| Falls prevalence | Number of falling events occurred from the participant or caregiver | From enrollment to the last assessment session at 8 weeks |
| Skin integrity | Occurrence of any injury of the skin in the areas of contact and produced by the use of the device | From enrollment to the last assessment session at 8 weeks |
| Pain assessment | pain measured by the Visual Analogic Scale (VAS) by the participant, scored from 0 to 10, being 0 "no pain" and 10 "unbearable pain" | From enrollment to the last assessment session at 8 weeks |
| Heart rate | measurement of heart rate | from the beginning to the end of treatment at 6 weeks |
| Oxygen saturation | measurement of Oxygen saturation when medical prescription | from the beginning to the end of treatment at 6 weeks |
| Blood pressure | measurement of blood pressure. Systolic and diastolic pressures will be assessed | from the beginning to the end of treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| State of mind | It will be done with a Likert-type scale from 1 to 5 (1: very sad; 2: sad; 3: indifferent; 4: happy; 5: very happy). This scale will be administered before and after each therapeutic session. | from the beginning to the end of treatment at 6 weeks |
| Health perception |
| Measure | Description | Time Frame |
|---|---|---|
| Classification of Spinal Cord Injury | The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) is a standardized tool for assessing and classifying spinal cord injuries Sensory function: Assessed in 28 dermatomes per side for light touch and pinprick sensations, scored as 0 (absent), 1 (impaired), or 2 (normal). Maximum score: 224 points (112 per modality). Motor function: Evaluated in 10 key muscle groups per side, using a 0-5 strength scale. Maximum score: 100 points. ASIA Impairment Scale: Classifies the severity of spinal cord injury into five categories: from A (complete) to E (normal). |
Inclusion Criteria:
Inclusion criteria related to device characteristics:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Cumplido Trasmonte | Contact | 0034 914900090 | carlos.cumplido@marsibionics.com | |
| Elisa López-Dolado | Contact | 0034 925247700 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nacional Parapléjicos | Recruiting | Toledo | 45004 | Spain |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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|
| User and/or caregiver perception of the device |
Questions that are scored from 0 to 5 on aspects related to comfort, weight, volume, etc |
| From enrollment to the last assessment session at 8 weeks |
| Device usage data | Total walking time. Unit of Measure: Minutes. | From enrollment to the last assessment session at 8 weeks |
| Number of steps | Number of steps with the device | From enrollment to the last assessment session at 8 weeks |
| Usage modes | two different usage modes (active and automatic). | From enrollment to the last assessment session at 8 weeks |
| Speed | speed achieved with the device (steps per minute) | From enrollment to the last assessment session at 8 weeks |
| Range of motion | Passive Degree to which a joint can move (hip, knee, and ankle joints in both legs). From 0º to 180º. | From enrollment to the last assessment session at 8 weeks |
EQ-5D scale assesses five dimensions of health: Mobility, Self-care, Usual activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five levels of severity (No problems, Slight problems, Moderate problems, Severe problems, and Extreme problems). |
| from enrollment to the last assessment session at 8 weeks |
| Health perception | Visual Analogue Scale (VAS) is a vertical scale where patients rate their current health on a scale from 0 to 100 (0 representing "the worst health you can imagine" and 100 representing "the best health you can imagine. | from enrollment to the last assessment session at 8 weeks |
| 10 Meter Walking Test (10 MWT) measured with ATLAS 2030 | The 10 Meter Walking Test (10MWT) records the time taken by the participant to walk 10 meters with the device in motion intent mode. | From enrollment to the last assessment session at 8 weeks |
| Effort perception | Borg Rating of Perceived Exertion (RPE), is a tool used to measure the intensity of physical activity based on how hard you feel your body is working. - Modified Borg Scale (0-10): This version ranges from 0 to 10, where 0 means "nothing at all" and 10 means "very, very hard." It's often used in clinical settings to assess symptoms like breathlessness, chest pain, and muscle fatigue. | from the beginning to the end of treatment at 6 weeks |
| From enrollment to the last assessment session at 8 weeks |
| Disability | The Spinal Cord Independence Measure (SCIM) III. It is composed of 19 items that assess three main domains:
| From enrollment to the last assessment session at 8 weeks |
| Walking ability | WISCI II (Walking Index for Spinal Cord Injury): Assess walking ability and level of assistance needed. Scoring: 0: Cannot walk. 20: Independent walking. Intermediate (1-19): Varies with assistive devices. | From enrollment to the last assessment session at 8 weeks |
| D014947 | Wounds and Injuries |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |