Exoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study
14 de mayo de 2019 actualizado por: Chester Ho, MD, University of Calgary
This study will examine the safety and feasibility of using an exoskeleton in subjects who are less than 6 months post spinal cord injury (SCI).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Study participants with acute SCI (<6 months post injury) will be involved in an indoor, overground walking program.
Locomotor training will include 90 minute sessions (including time to don and doff the device) for 30 training hours (90 minutes, 2-3 times weekly for 8 weeks.)
Tipo de estudio
Intervencionista
Inscripción (Actual)
11
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T2N2T9
- Foothills Medical Centre
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
15 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Individuals aged 15 and older with acute SCI (<6 months post) Etiology of SCI can be traumatic or non traumatic Includes motor complete (AIS A,B) and motor incomplete (AIS C,D) at C7 or below.
Participants must be able to follow 2 step commands Participants must be deemed medically stable by responsible physician or physiatrist
- Spine considered stable by surgeon
- Surgical wound is approximated and surrounding tissue appears healthy
- Participant does not require supplemental Oxygen
- Participant is able to have any IV or other lines disconnected.
Must meet manufacturer's requirements for use of Ekso GT:
Exclusion Criteria:
- Range of motion (ROM) restrictions that would prevent a patient from achieving a normal, reciprocal gait pattern, or would restrict a patient from completing normal sit-to-stand or stand-to-sit transitions Spinal instability Untreated deep vein thrombosis (DVT) Decreased standing tolerance due to orthostatic hypotension Significant osteoporosis that prevents safe standing or may increase the risk of fracture caused by standing or walking Uncontrolled spasticity - score of 3 or higher on modified Ashworth Scale Uncontrolled Autonomic Dysreflexia (AD) Skin integrity issues on contact surfaces of the device or on surfaces that would prohibit sitting (sacrum, greater trochanter, proximal tibia)
Upper leg length discrepancy greater than half an inch (> .5") or lower leg discrepancy greater than three-quarters of an inch (>.75") Cognitive impairments resulting in motor planning or impulsivity concerns Pregnancy
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Overground walking program
Study participant will be involved in an indoor, overground walking program using an exoskeleton wearable walking device under the supervision of a physiotherapist.
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This is an open study and so all participants involved with be using the exoskeleton to determine the safety and feasibility of its use during the acute rehabilitation phase.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline cardiorespiratory status throughout each of the 25 sessions
Periodo de tiempo: Every 15 minutes during each training session including: pre and post initial stand, at 15 minute intervals during training and at the end of each of the 25 total sessions, on average of 2 months
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Blood pressure, heart rate and peripheral oxygen saturation and will be used to identify any cardiovascular issues of orthostatic hypotension or autonomic dysreflexia.
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Every 15 minutes during each training session including: pre and post initial stand, at 15 minute intervals during training and at the end of each of the 25 total sessions, on average of 2 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Skin integrity
Periodo de tiempo: At the beginning and end of each training session for 25 sessions, on average of 2 months
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A visual inspection of areas of significant weight bearing and skin/machine interface will take place at the beginning and end of each training session to monitor for skin breakdown or compromise.
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At the beginning and end of each training session for 25 sessions, on average of 2 months
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Falls
Periodo de tiempo: From onset to cessation of each training session for 25 sessions, on average of 2 months
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Any incidence of falls will be recorded and the participant will be evaluated for injury by unit medical staff or on site emergency staff if warranted.
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From onset to cessation of each training session for 25 sessions, on average of 2 months
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Pain visual analogue scale
Periodo de tiempo: At the beginning and end of each training session for 25 sessions, on average of 2 months
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Participants draw an intersecting line on a 10 cm line (scale) in order to rate their amount of subjective pain.
The distance on the 10 cm line is measured from the left side (no pain) and turned into a numerical value.
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At the beginning and end of each training session for 25 sessions, on average of 2 months
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Borg scale of perceived exertion
Periodo de tiempo: At the beginning, mid point (30 min) and end (60 min) of each training session for 25 sessions, on average of 2 months
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Subjects are shown the Borg scale of perceived exertion and are asked to choose the number/descriptor that best aligns with their current level of exertion at 0, 30 and 60 minutes.
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At the beginning, mid point (30 min) and end (60 min) of each training session for 25 sessions, on average of 2 months
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10 meter walk test
Periodo de tiempo: Training sessions 1, 13 and 25 out of the 25 total sessions, on average of 2 months
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Time in seconds it takes a subject to walk a distance of 10 meters.
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Training sessions 1, 13 and 25 out of the 25 total sessions, on average of 2 months
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6 minute walk test
Periodo de tiempo: Training sessions 1, 13 and 25 of the 25 total sessions, on average of 2 months
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Total distance a participant is able to walk in 6 minutes will be measured.
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Training sessions 1, 13 and 25 of the 25 total sessions, on average of 2 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Chester Ho, MD, University of Calgary
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2016
Finalización primaria (Actual)
1 de febrero de 2018
Finalización del estudio (Actual)
1 de febrero de 2018
Fechas de registro del estudio
Enviado por primera vez
20 de abril de 2016
Primero enviado que cumplió con los criterios de control de calidad
4 de mayo de 2017
Publicado por primera vez (Actual)
9 de mayo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de mayo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
14 de mayo de 2019
Última verificación
1 de mayo de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EKSO22214
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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