The ReWalk Exoskeletal Walking System for Persons With Paraplegia
Palabras clave
Abstracto
Descripción
Potential participants will be pre-screened with the inclusion criteria for eligibility. The informed consent process will begin for those participants who have been determined to meet the inclusion criteria. After the potential participant's signed consent has been provided, further evaluations for eligibility will be performed (e.g., there are several medical and physical exclusion criteria). Those potential participants who meet both the inclusion and exclusion criteria will be eligible to enroll into the ReWalk-I study. Baseline evaluations and personalized measurements for fitting to the ReWalk-I will be performed over one week, before the training sessions begin. The ReWalk sessions will consist of a Learning Phase (12 sessions in 4 weeks) and a Training Phase (18 sessions in 6 weeks). These times may vary by each participant's ReWalk learning curve. Training will begin with sit-to-stand, stand-to-sit, and standing balance activities. Progression to walking will occur as skills advance. Each session will be an average 50 minutes, with 3 sessions per week. The skills to be learned include 1) sit-to-stand, 2) stand-to-sit, 3) 2-arm standing balance, 4) 1-arm standing balance, 5) walking, and 6) stair climbing. The study evaluations will be repeated after the Learning Phase, after the Training Phase and 1-month post training follow-up.
fechas
| Verificado por última vez: | 07/31/2020 |
| Primero enviado: | 09/13/2011 |
| Inscripción estimada enviada: | 10/17/2011 |
| Publicado por primera vez: | 10/18/2011 |
| Última actualización enviada: | 08/12/2020 |
| Última actualización publicada: | 08/24/2020 |
| Fecha de los primeros resultados enviados: | 01/18/2018 |
| Fecha de los primeros resultados de CC enviados: | 08/12/2020 |
| Fecha de los primeros resultados publicados: | 08/24/2020 |
| Fecha de inicio real del estudio: | 01/31/2011 |
| Fecha estimada de finalización primaria: | 08/07/2015 |
| Fecha estimada de finalización del estudio: | 08/07/2015 |
Condición o enfermedad
Intervención / tratamiento
Device: Powered Exoskeleton
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: Powered Exoskeleton persons with SCI trained to use a powered exoskeleton to ambulate overground | Device: Powered Exoskeleton |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Método de muestreo | Non-Probability Sample |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: 1. Males or females with paraplegia 2. Duration of SCI >6 months 3. Ages 18 to 65 y 4. Height 160 to 190cm (63-75in or 5'3" to 6'3") 5. Weight <100kg (<220 lb) 6. Ability to give informed consent Exclusion Criteria: 1. Diagnosis of neurological injury other than SCI including: - Multiple sclerosis (MS) - Stroke - Cerebral Palsy (CP) - Amyotrophic lateral sclerosis (ALS) - Traumatic Brain injury (TBI) - Spina bifida - Parkinson's disease (PD) - Other neurological condition that the study physician considers in his/her clinical judgment to be exclusionary 2. Severe concurrent medical disease, illness or condition 3. Recent lower extremity fracture within the past 2 years; 4. DXA results indicating a t-score below -3.0 and knee BMD <0.70 gm/cm2 5. Systemic or peripheral infection 6. Atherosclerosis, congestive heart failure, or history of myocardial infarction 7. Trunk and/or lower extremity pressure ulcers; 8. Other illness, that the study physician considers in his/her clinical judgment to be exclusionary 9. Severe spasticity (defined by an Ashworth score of >4.0 or clinical impression of the study physician or physical therapist) 10. Significant contractures defined as flexion contracture limited to 35º at the hip and 20º at the knee; 11. Diagnosis of heterotrophic ossification of the lower extremities; 12. Femoral neck or the total proximal femur bone mineral density T-scores < -3.0 13. Psychopathology documentation in the medical record or history of that may conflict with study objectives 14. Hypertension (SBP>140, DBP>90) 15. Pregnancy and/or lactating females |
Salir
Medidas de resultado primarias
1. Count to Achieve Mobility Skills [ReWalk training at 4 and 12 weeks, and 1-month follow-up]
