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

Deficit Fields for Stroke Recovery

8 de junio de 2021 actualizado por: James Patton, Shirley Ryan AbilityLab

Error-enhanced Learning & Recovery in 2 & 3 Dimensions

This study investigates the potential of customized robotic and visual feedback interaction to improve recovery of movements in stroke survivors. While therapists widely recognize that customization is critical to recovery, little is understood about how take advantage of statistical analysis tools to aid in the process of designing individualized training. Our approach first creates a model of a person's own unique movement deficits, and then creates a practice environment to correct these problems. Experiments will determine how the deficit-field approach can improve (1) reaching accuracy, (2) range of motion, and (3) activities of daily living. The findings will not only shed light on how to improve therapy for stroke survivors, it will test hypotheses about fundamental processes of practice and learning. This study will help us move closer to our long-term goal of clinically effective treatments using interactive devices.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

45

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

    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Rehabilitation Institute of Chicago

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 100 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

STROKE SURVIVORS:

  • adult (age >18)
  • Chronic stage stroke recovery (8+ months post)
  • available medical records and radiographic information about lesion locations
  • strokes caused by an ischemic infarct in the middle cerebral artery
  • primary motor cortex involvement
  • a Fugl-Meyer score (between 15-50) to evaluate arm motor impairment level

HEALTHY CONTROL PARTICIPANTS:

  • adult (age >18)
  • healthy individuals with no history of stroke or neural injury

Exclusion Criteria:

  • bilateral paresis;
  • severe sensory deficits in the limb
  • severe spasticity (Modified Ashworth of 4) preventing movement
  • aphasia, cognitive impairment or affective dysfunction that would influence the ability to perform the experiment
  • inability to provide an informed consent
  • severe current medical problems
  • diffuse/multiple lesion sites or multiple stroke events
  • hemispatial neglect or visual field cut that would prevent subjects from seeing the targets.

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Deficit-fields to reduce error
We hypothesize that a deficit-field design, using the statistics of a patient's errors to customize training, will provide optimal augmentation that varies during motion as needed. We will compare the training effects of error deficit-fields with previous methods of error augmentation to improve reaching ability.
Stroke survivors exhibit error in both reaching extent and abnormal curvatures of motion. Prior error augmentation techniques multiply error by a constant at each instant during movement. However, magnification of spurious errors may provoke over-compensation. We hypothesize that a deficit-field design, using the statistics of a patient's errors to customize training, will provide optimal augmentation that varies during motion as needed. We will compare the training effects of error deficit-fields with previous methods of error augmentation to improve reaching ability.
Experimental: Deficit-fields to expand range of motion
Amplifying augmentation can expand motor exploration and improve skill retention in patients. Using motor exploration patterns from each patient, we will form customized deficit-fields to recover normal joint workspace. We will compare augmentation training that either amplifies or diminishes the observed deficits (Expt-1). We also compare deficit-fields with our prior augmentation methods to determine the added value of increased customization (Expt-2).
Motor deficits manifest in the workspace limitations of joints, i.e. reduced range of motion, uneven extension-flexion, inter-joint coupling, and unwanted synergies. Our work builds upon these ideas by augmenting self-directed movement for training coordination. We found that amplifying augmentation can expand motor exploration and improve skill retention in patients. Using motor exploration patterns from each patient, we will form customized deficit-fields to recover normal joint workspace. We will compare augmentation training that either amplifies or diminishes the observed deficits (Expt-1). We also compare deficit-fields with our prior augmentation methods to determine the added value of increased customization (Expt-2).
Experimental: Deficit-fields to improve function
Here we present visual distortion of whole body movement during manual tasks during standing, including reaching, grasping, and object manipulation. We compare the training effects of feedback based on deficit-fields versus practice with normal vision.
Clinicians have recognized the benefits of training on everyday tasks (Hubbard, Parsons et al. 2009), as well as practice with whole-body actions (Boehme 1988; Bohannon 1995). However, typical robotic systems have only a single contact point and cannot drive the multiple joints involved in functional tasks. Visual distortions (e.g. a shift, rotation or stretch) can promote adaptation even without forces. Here we present visual distortion of whole body movement during manual tasks during standing, including reaching, grasping, and object manipulation. We compare the training effects of feedback based on deficit-fields versus practice with normal vision.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Arm motor recovery scores on the Fugl-Meyer
Periodo de tiempo: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
Change from baseline in arm motor recovery as measured by Fugl-Meyer
Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of blocks transferred in Box and Blocks Test
Periodo de tiempo: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
Change from baseline in number of blocks transferred during Box and Blocks Test
Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
Modified Ashworth Scale (MAS)
Periodo de tiempo: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
Change from baseline in amount of spasticity in elbow flexors and extensors
Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
Elbow active range of motion (ROM)
Periodo de tiempo: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
Change from baseline measured in degrees for elbow flexion and extension
Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
Chedoke McMaster Stroke Assessment for Hand
Periodo de tiempo: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
Change in baseline in amount of hand motor recovery as measured by Chedoke scale
Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
Time and completion score for Action Research Arm Test (ARAT)
Periodo de tiempo: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
Change in baseline score and time for completion of functional measures as part of ARAT
Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: James L Patton, PhD, Shirley Ryan AbilityLab

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 (Actual)

1 de mayo de 2013

Finalización primaria (Actual)

30 de junio de 2019

Finalización del estudio (Actual)

30 de junio de 2019

Fechas de registro del estudio

Enviado por primera vez

1 de octubre de 2015

Primero enviado que cumplió con los criterios de control de calidad

6 de octubre de 2015

Publicado por primera vez (Estimar)

7 de octubre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de junio de 2021

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

8 de junio de 2021

Última verificación

1 de octubre de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • RehabilitationIC
  • 2R01NS053606-05A1 (Subvención/contrato del NIH de EE. UU.)

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