Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

AAN Robotic Therapy in SCI

13 de junio de 2016 actualizado por: William Marsh Rice University

Effect of Assist-as-needed Robot Aided Rehabilitation Strategies in Subjects With Incomplete Spinal Cord Injury

The purpose of this study is to demonstrate that a robot-aided rehabilitation protocol that follows the "assist-as needed" paradigm provide statistically significant improvements in arm and hand motor functions when compared to robot-aided protocols that passively move patients' arms along pre-defined trajectories, in patients with incomplete spinal cord injury (SCI).

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

14

Fase

  • Fase 1

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

    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • TIRR Memorial Hermann
      • Houston, Texas, Estados Unidos, 77005
        • Rice University

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

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Twenty adults with chronic incomplete SCI (according to American Spinal Injury Association (ASIA) Impairment Scale (AIS) C-D level) will be recruited from TIRR and from the Houston area.

Inclusion Criteria:

  1. Providing written informed consent prior to any study related procedures;
  2. Age between 18-75 years;
  3. Diagnosis of chronic complete or incomplete spinal cord injury as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months;
  4. Not being involved in any specific exercise program (e.g., NMES, FES) within the previous 3 months;
  5. No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
  6. Eligibility for standard rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation);
  7. No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing;

Exclusion Criteria: Subjects will be excluded if they have:

  1. Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score > than 3 out of 4;
  2. Subject who cannot provide self-transportation to the study location.

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: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Assist-As-Needed Control

Subjects in this group will interact with a robotic exoskeleton, the MAHI Exo-II, programmed with an "adaptive mode". In this mode, the robot will continuously assist motion along pre-defined trajectories, but will employ an "assist-as-needed" protocol.

Here, the amount of assistance provided by the robot will not be always the 100% of that required to complete the task (as in the position control mode), but only a fraction of it. The robot will continuously estimate the residual movement capabilities of the subject, depending on the specific joint addressed in the movement, and will estimate the remaining contribution needed to complete the movement following a predefined trajectory, thus avoiding to over-support motion.

Otros nombres:
  • Robot-aided movement therapy
Comparador activo: Subject-Triggered Control
Subjects in group B will interact with a robotic exoskeleton, the MAHI Exo-II, controlled via the subject-triggered mode, as in a previous clinical trial with the MAHI Exo II robotic system. In the subject triggered mode, the MAHIExo II is commanded to regulate joints motion following a position-control control scheme, and using as desired trajectories standardized single-joints profiles that require motion of one of the axes of the exoskeleton (i.e. elbow flexion and extension, forearm pronation and supination, wrist radial and ulnar deviation, wrist flexion and extension). The switch to position control of the exoskeleton is triggered by the application of sufficient force by the subject, in a previous phase where the robot implements a virtual wall.
Otros nombres:
  • Robot-aided movement therapy

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change in ARAT score
Periodo de tiempo: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Modified Ashworth Scale
Periodo de tiempo: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Change in Grip Pinch Strength Assessment
Periodo de tiempo: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Change in Graded Redefined Assessment of Strength, Sensibility and Prehension
Periodo de tiempo: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Change in Smoothness metrics
Periodo de tiempo: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Measured via analysis of point-to-point reaching movements performed with the robot. Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed
Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Change in smoothness metrics
Periodo de tiempo: Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start
Measured via analysis of point-to-point reaching movements performed with the robot. Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed
Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Marcia K. O'Malley, PhD, William Marsh Rice University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 mayo de 2014

Finalización primaria (Actual)

1 de septiembre de 2015

Finalización del estudio (Actual)

1 de septiembre de 2015

Fechas de registro del estudio

Enviado por primera vez

25 de mayo de 2016

Primero enviado que cumplió con los criterios de control de calidad

13 de junio de 2016

Publicado por primera vez (Estimar)

16 de junio de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

16 de junio de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

13 de junio de 2016

Última verificación

1 de mayo de 2016

Más información

Términos relacionados con este estudio

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. .

Suscribir