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| Name | Class |
|---|---|
| National Research Council, Spain | OTHER_GOV |
| Hospital Infantil Universitario Niño Jesús, Madrid, Spain | OTHER |
| Hospital Universitario La Paz | OTHER |
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Cerebral Palsy (CP) is the first cause of motor disability in children worldwide. ATLAS 2030 is a robotic gait exoskeleton designed to rehabilitate children with motor disability. The objective of this study is to analyse the efficacy of a training program with ATLAS 2023 in chilren with CP.
A sample of children with CP will be divided into 2 groups, the experimental group will receive 32 sesions withe the ATLAS 2030 exoskeleton, whereas the control group will continue to receive their regular conventional therapy. Assessments will be performed at the beginning and the end of the intervention, as well as after 6, 9 and 12 months of the end of the intervention for follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exoskeleton group | sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their of their routine rehabilitation |
| |
| Control group | The children included in the control group will continue receiving their usual conventional therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATLAS 2030 | Device | sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their routine rehabilitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gross Motor Function Measure-88 (GMFM-88) | To measure changes in gross motor function in children with cerebral palsy using the Gross Motor Functional Measure-88. The minimum value is 0 and the maximum value is 100 .When the GMFM score is lower, the skill level is lower. | At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Ashworth Scale (MAS) | changes in spasticity measured by the Modified Ashworth Scale (MAS). The spasticity of each muscle group is measured with a scale scored from 0 to 4, where 0 means no spasticity and 4 means the joint is fixed and therefore, the highest level of spasticity | Through study completion, along 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Children diagnosed with cerebral palsy with Gross Motor Function Classification level III (children walk using a hand-held mobility device in most indoor settings) or IV (children use methods of mobility that require physical assistance or powered mobility in most settings).
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| Name | Affiliation | Role |
|---|---|---|
| Olga Arroyo Riaño | Hospital Universitario Gregorio Marañón | Principal Investigator |
| María Teresa Vara Arias | Hospital Infantil Universitario Niño Jesús | Principal Investigator |
| Ignacio Martínez Caballero | Hospital Infantil Universitario Niño Jesús | Principal Investigator |
| Sandra Espinosa García | Hospital Univsersitario La Paz | Principal Investigator |
| Sofía García de las Peñas | Hospital 12 de Octubre | Principal Investigator |
| Elena García Armada | National Research Council, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Gregorio Marañón | Madrid | 28007 | Spain | |||
| Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Hospital Universitario 12 de Octubre |
| OTHER |
| Hospital General Universitario Gregorio Marañon | OTHER |
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| Pediatric Quality of Life Inventory (PedsQLTM) |
Changes in self perceived quality of life measured by the Pediatric Quality of Life Inventory (PedsQLTM). Every item is measured on a scale from 0 (higher quality of life) to 4 (lower quality of life) |
| At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up) |
| Changes in Gait Deviation Index (GDI) | Changes in Gait Deviation Index (GDI) measured with a tridimensional motion analysis system | At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up) |
| Madrid |
| 28009 |
| Spain |
| Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia | Madrid | 28009 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |