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| Name | Class |
|---|---|
| Hospital Miguel Servet | OTHER |
| ATADES | UNKNOWN |
| Universidad de Zaragoza | OTHER |
| Spanish National Research Council |
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The main objective of this study is to assess the usability and efficacy of receiving therapy with the peaditric exoskeleton ATLAS 2030in children with gait impairment due to a cerebral palsy condition. It will be valued the impact of rehabilitation with the exoskeleton at the physical level on parameters such as joint range, spasticity, as well as the impact in quality of life. It is also assessed the impact at the level of functionality of the participants, through the administration of different functional assessment scales.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Treatment | No Intervention | The children will continue with their current rehabilitation program | |
| Treatment with the ATLAS 2030 Exoskeleton | Experimental | The children will receive 2 hours of exoskeleton ATLAS 2030 gait training a week for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATLAS 2030 exoskeleton | Device | Individualized Rehabilitation Treatment with the ATLAS 2030 Exoskeleton consists of the following phases:
|
| Measure | Description | Time Frame |
|---|---|---|
| Gross Motor Function Classification System | To indentify the diffrent levels of the Gross Motor Function Classification System who can use the ATLAS 2030 exoskeleton. The Gross Motor Function Classification System goes from Level 1 (can walk indoors and outdoors and climb stairs without using hands for support; can perform usual activities such as running and jumping; has decreased speed, balance and coordination) to Level 5 (has physical impairments that restrict voluntary control of movement and the ability to maintain head and neck position against gravity; is impaired in all areas of motor function; cannot sit or stand independently, even with adaptive equipment; cannot independently walk, though may be able to use powered mobility) | Every month up to 3 months |
| To quantify number of steps taken within the device | Quantity of steps taken within the exoskeleton | Every session up to 28 sessions |
| Changes in joint range of motion | To evaluate the joint range of motion changes at the hip, knee and ankle after the ATLAS 2030 use measured by goniometer | Every session up to 28 sessions |
| Changes in spasticity | To evaluate spasticity changes at the lower limb muscle groups after ATLAS 2030 use by Modified Asworth Scale | Every session up to 28 sessions |
| Changes in the Six-Minute Walking Test performance | To assess changes in the distance the child can walk in six minutes by using the Six-Minute Walking Test | Every month up to three months |
| Changes in the 10 Meters Walking Test performance |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the ATLAS 2030 | Measured as the occurrence of adverse events such as onset of pain, fatigue, presence of falls or alteration of the integrity of the user's skin, by the use of the device. | at study completion |
| The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colegio de Educación Especial San Martín de Porres (ATADES) | Zaragoza | Aragon | 35012 | Spain | ||
| ATENPACE |
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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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| OTHER_GOV |
| Fundación Bobath Madrid | UNKNOWN |
| ATENPACE Madrid | UNKNOWN |
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|
To assess changes in the time needed to walk 10 meters by using the 10 Meters Walking Test
| Every month up to three months |
| Changes in the time walked within the device | To assess possible changes in the time walked within the device | Three months |
| Changes in the Gross Motor Function Measure 88 for children with cerebral palsy (GMFM-88) | To evaluate possible changes in the gross motor function after 3 months of ATLAS 2030 use twice a week where a higher score means child´s gross motor function is better | Every month up to three months |
| Changes in the Functional Independence Measure for Children (WeeFim) | To evaluate possible changes in the overall functionality after 3 months of ATLAS 2030 use twice a week by using the Functional Independence Measure for Children where a higher score means the child is more functional, more independant | Every month up to three months |
| Cerebral Palsy Quality of Life | To assess possible changes in the quality of life of the children after using the ATLAS 2030 for 3 months twice a week by using the Cerebral Palsy Quallity of Life scale where a higher percentage means a better quality of life | Three months |
To assess both professionals and patients´satisfaction when using the ATLAS 2030 |
| at study completion |
| Acceptability | Measured through the dropout rate of the participants. | at study completion |
| Accessibility | Measure such as the relationship between the number of patients recruited and potential patients who were not recruited | at study completion |
| Madrid |
| Spain |
| Centre for Automation and Robotics, Marsi Care | Madrid | Spain |
| Fundación Bobath | Madrid | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | Spain |
| Universidad de Zaragoza | Zaragoza | Spain |