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| Name | Class |
|---|---|
| Hospital Universitario La Paz | OTHER |
| National Research Council, Spain | OTHER_GOV |
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The purpose of this multicentric study is to assess the rehabilitative effect derived from the use of the ATLAS exoskeleton in children with neuromuscular diseases or cerebral palsy and with a level of less than 3 or less in the Functional Ambulation Classification (FAC) as a consequence of their disease, as well as the assessment of other physical, functional and quality of life parameters of interest. For this purpose, the exoskeleton will be used as a rehabilitation and walking assistance tool.
Before starting the study programme and if deemed necessary, a preliminary phase consisting of 1 to 3 sessions will be carried out during which the patient will be shown the exoskeleton for the first time and it will be considered whether any improvements to the different parts of the device or the software are necessary to increase the ergonomics and comfort of the patient.
The objectives of the study are:
The time period of the study will be as long as necessary to reach the desired number of participants, in this case 10 children (N=10). The participants will be patients affected by neuromuscular diseases or cerebral palsy and will be selected on the basis of the following inclusion/exclusion criteria:
Inclusion criteria: 1. Children with neuromuscular disease or cerebral palsy who present gait disturbances or no gait disturbance. 2. Children between 3 and 11 years of age.
Exclussion criteria: not fulfil the usage criteria of the device.
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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 and will also have the technical supervision of personnel specialised in the handling of the laboratory and the robotic device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATLAS 2030 | Device | The participant will attend the laboratory every week, two days a week. The therapy will consist of the use of the exoskeleton for rehabilitative purposes. At the end of each three-month period, each patient's data will be monitored. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscular balance | Strength measured in Newtons with a Hand-Held Dinamometer for elbow flexion, neck lateralization, ankle plantarflexion and dorsiflexion, knee flexion and extension. | 1 month |
| Expanded Hammersmith Functional Motor Scale | Motor functionality measured for children with Spinal Muscular Atrophy | 3 months |
| Gross Motor Function Measure 88 (GMFM-88) | Motor functionality measured for children with Cerebral Palsy. | 3 months |
| Respiratory rate | Respiratory rate measured manually in breaths per minute using chronometer | 1 day |
| Heart rate | Measured in beats per minute using vital sign monitor | 1 day |
| Oxigen Saturation | Measured in %O2 using vital sign monitor | 1 day |
| Blood preasure | measured in mmHg with a sphyngomanometer | 1 day |
| Respiratory functional parameters | Measured by Spirometer (volumes measured in litres and pressures in mmHg) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Espinosa GarcÃa, Medicine | Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MarsiCare | Arganda | Madrid | 28500 | Spain |
all IPD that underlie results in a publication
starting 6 months after publication
Researchers who will asked for this data and with previous approval provided by reserach sponsor
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| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D002547 | Cerebral Palsy |
| D014897 | Spinal Muscular Atrophies of Childhood |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Quality of life assessment | Quality of life iof the children measured using the KINDL questionnaire. | 3 months |
| Joint range of motion | Range of motion in degrees of hip, knee and ankle movements using a manual goniometer. | 1 month |
| Revised Upper Limb Module (RULM) | Upper limb quality of movement using RULM scale for Spinal Muscular Atrophy children | 3 months |
| Quality Upper Extremity Skill test (QUEST) | Upper limb quality of movement using QUEST scale for cerebral palsy children | 3 months |
| The Functional Independence Measure for Children (WeeFim) | WeeFim scale for CP children. | 3 months |
| Egen Klassifikation | Functional ability measured using EK2 scale for SMA | 3 months |
| Skin integrity | Skin alterations assessing their localization, size (centimeters), redness and temperature increase. | 1 day |
| Fatigue | Patient fatigue measured by Borg fatigue scale for children ages | 1 day |
| Pain assessment | Patient pain measured by EVA faces scale for children ages | 1 day |
| Peak Flow cough | Measured in litres per minute using a Peak flowmeter | 1 week |
| D009134 | Muscular Atrophy, Spinal |
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D016472 | Motor Neuron Disease |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |