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| Name | Class |
|---|---|
| Hospital Universitario La Paz | OTHER |
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This study aims to evaluate the safety, usability and acceptability of a motorized mobility assistance exoskeleton. The protocol explores the use of the motorized device during static and dynamic rehabilitation sessions focused on walking and functional activities, with the expectation of evaluating the safety and usability of the device in the population studied. The protocol has been focused on defining how the device can be used appropriately in this population in a safe and effective manner by rehabilitation specialists. The study also aims to assess the safety of clinical staff who implement the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 9 treatment sessions will be performed with the ATLAS2030 exoskeleton. The rehabilitation sessions last approximately 90 minutes. Two sessions are scheduled per week, for two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exoskeleton rehabilitation | Device | The participants will perform physical therapy with the ATLSA2030 device, for 90 minutes per session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as number of serious device adverse events | Presence of a serious device adverse events where the participant or therapist is involved | after each use of exoskeleton, for 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as presence of adverse events or adverse device events | Presence of a device adverse events where the participant or therapist is involved. | after each use of exoskeleton, for 5 weeks |
| Exercises [measured as time per exercise in seconds] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MarsiCare | Arganda | Madrid | 28500 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35854321 | Derived | Cumplido-Trasmonte C, Ramos-Rojas J, Delgado-Castillejo E, Garces-Castellote E, Puyuelo-Quintana G, Destarac-Eguizabal MA, Barquin-Santos E, Plaza-Flores A, Hernandez-Melero M, Gutierrez-Ayala A, Martinez-Moreno M, Garcia-Armada E. Effects of ATLAS 2030 gait exoskeleton on strength and range of motion in children with spinal muscular atrophy II: a case series. J Neuroeng Rehabil. 2022 Jul 19;19(1):75. doi: 10.1186/s12984-022-01055-x. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D014897 | Spinal Muscular Atrophies of Childhood |
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Measured as time per event for at each therapy session.
| after each use of exoskeleton, for 5 weeks |
| Transfers [measured as time to carry out the transfers in seconds] | Measured as time to carry out the transfers | At each use of exoskeleton, for 5 weeks |
| Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants] | Measured as abandon ratio | At the end of the study, at the 5th week |
| Accessibility [number of potential participants in relation with the included participants] | Measured as relation between number of participants and number of potential participants which weren't recruited | At the end of the study, at the 5th week |
| Fall Prevalence [number of falls during the using of the device] | Number of falling events ocurred from the participant or therapist | During the use of the device, for 5 weeks |
| Skin integrity [number of skin injuries related to the device] | skin integrity measured as the number of skin injuries | before and after each use of exoskeleton, for 5 weeks |
| Pain [Wong-Baker FACES Pain Rating Scale] | Pain registered before and after the use of the device, by the participant and therapist. The options are from 1 to 6. A higher score means a worse outcome. | Before and after the use of the device, during 5 weeks |
| Fatigue [Borg Rating Scale of Perceived Exertion] | Fatigue registered before and after the use of the device, by the participant and therapist. Measured from 0 to 10, being 0 as fully rested and 10 very tired. A higher score means a worse outcome. | Before and after the use of the device, during 5 weeks |
| Spasticity [Modified Ashworth Scale] | Spasticity registered before and after the use of the device | Before and after the use of the device, during 5 weeks |
| Heart rate [sphygmomanometer] | Number of heart bets per minute | Before and after the use of the device, during 5 weeks |
| Physical evaluation [number of physical injuries detected] | Physical Evaluation as presence of tissue damage | Before and after the use of the device, during 5 weeks |
| Muscle Strength [measured with Hand Held Dynamometer in N] | Muscle Strength measured at hip, knee and ankle muscles | At the first day, 3rd week and 5th week |
| ROM [measured with goniometer] | Range of Movement | At the first day, 3rd week and 5th week |
| Functional Mobility [Functional Ambulation Category scale] | Functional Mobility with and without the device | At the first day, 3rd week and 5th week |
| System Usability [System Usability Scale] | Measurement of System's Usability measured by the therapist | At the end of the study, 5th week |
| User perception of the device [QUEST 2.0 and QUEST 2.1] | QUEST 2.0 will be assessed by the therapist, and QUEST 2.1 will be assessed by the participant | At the end of the study, 5th week |
| Distance covered walking [6MWT] | 6MWT recorded using the device | At the first day, 3rd week and 5th week |
| Device malfunction [as number and type of device malfunction] | Any device malfunction will be recorded | During the use of the device, for 5 weeks |
| Particpant's stability [Functional Reach Test] | Functional Reach Test | At the first day, 3rd week and 5th week |
| Systolic/Diastolic Pressure [sphygmomanometer] | Systolic Pressure and Diastolic Pressure measured with sphygmomanometer (measured in mmHg) | Before and after the use of the device, during 5 weeks |
| Breath Rate [number of breaths per minute] | Number of breaths per minute | Before and after the use of the device, during 5 weeks |
| SpO2 [pulse oximeter] | SpO2 measured as % | Before and after the use of the device, during 5 weeks |
| 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 |