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Evaluation of Robot Assisted Neuro-Rehabilitation (SRT3)

17 de octubre de 2019 actualizado por: VA Office of Research and Development

Evaluation of Robot Assisted Neuro-rehabilitation

Robotic devices are capable of providing therapy to the arm of patients with weakness due to stroke. Robotic therapy improves some aspects of stroke related arm weakness, but the use of the weak arm for real life situations often remains limited. The goal of this study is to determine the best way to use robotic devices and functional task training to improve the use of the stroke affected arm for real life situations. A secondary goal of this study is to determine how or if specific areas of the brain are excited before and after training. The use of a safe and painless magnetic field directed at the brain called transcranial magnetic stimulation (TMS) will be used at set intervals to gain a better understanding of brain activity during recovery.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

After obtaining informed consent, participants will undergo 3 sessions of baseline testing using upper extremity motor assessments of the shoulder, elbow, wrist, thumb and grip. Upper extremity kinematic and strength testing will be performed with the rehabilitation robots in measurement mode. The rehabilitation robot modules include the wrist, the planar (shoulder-elbow), and alternating wrist and shoulder-elbow robot. These robotic devices are cleared for marketing as a registered medical device under U.S. FDA regulations and are listed with the FDA both as an evaluation devices and as therapy devices.

Patients will be randomized to receive 12 weeks of robotic therapy sessions or 12 weeks of robot therapy combined with transition to task therapy. Study interventions will occur 3 times a week for 12 weeks. Robot therapy will consist of a progression through three robot modules: wrist, planar, and alternating wrist and shoulder-elbow robot. The progression will be sequential with four weeks of training on each robotic device. All participants will complete a motor activity log during this intervention phase.

TMS is being used for physiological measurement and evaluations will be conducted with each participant at baseline, week one, week five, eight, and final. TMS will also occur during the follow-up on week twenty-four.

Disability and depression questionnaires, upper extremity measures and evaluations of functional performance will be conducted during the study at baseline, and at training completion (visit 36). Patients will return twelve weeks after the end of the training period to determine whether any observed improvements persist.

Tipo de estudio

Intervencionista

Inscripción (Actual)

59

Fase

  • Fase 2
  • 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

    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21201
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

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

21 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnoses
  • Adequate language, and cognitive function to participate in training, testing, and informed consent process
  • The study arm of the participant will present with moderate to severe dysfunction based on Fugl-Meyer Motor Assessment range of 7 to 38
  • Stroke onset greater than 6 months for ischemic stroke and greater than 1 year for hemorrhagic stroke
  • Men or women over 21 years of age

Exclusion Criteria:

  • Seizures or treatment with anticonvulsant medications within the last 10 years (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing)
  • Treatment with any medications known to interfere with brain stimulation: any medication with central nervous system depressant activity, including, but not limited to benzodiazepines, barbiturates, and neuroleptics (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing)
  • Serious complicating medical conditions, contractures or orthopedic problems in the study arm limiting the range of joint movement for the study positions
  • Visual loss such that the participant cannot see the test patterns on the monitor of the training robot computer
  • Botox injection to the study arm within 3 months of enrollment or during the study period
  • Any change in the exercise regime involving the study arm. This includes starting any new exercise or discontinuing any current exercise regimen

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Robot Therapy
12 weeks of robotic therapy
Robot assisted arm exercise for 60 minutes progressing each month through three robot modules: wrist, planar, and alternating sessions on the wrist and planar robot 3x/week for 12 weeks.
Otros nombres:
  • Upper extremity (UE) robot-assisted exercise
Comparador activo: Transition to Task Training
12 weeks of task specific practice combined with robotic therapy
Robot therapy as described for 45 minutes and 15 minutes of task specific arm exercise using the hemiparetic arm 3x/week for 12 weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fugl-Meyer Motor Upper Extremity Assessment
Periodo de tiempo: Baseline, 12 week, and 24 week retention
This is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.
Baseline, 12 week, and 24 week retention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS)
Periodo de tiempo: week 12
week 12
Wolf Motor Function Test (WMFT)
Periodo de tiempo: Baseline, 12 week, and 24 week retention
The Wolf Motor Function Test (WMFT) examines UE function based on task performance time, quality of movement, and ability to hold a weight. Functional use and speed of movement are based on fifteen timed activities and two strength activities. It has high inter-rater reliability, internal consistency, and test-retest reliability. Timed tasks that cannot be completed default to a time score of 120 seconds. Faster times or a lower score in seconds represent better function. Improvement is represented by a decreased time to complete the tasks therefore a negative change score from baseline to follow-up indicates improvement.
Baseline, 12 week, and 24 week retention
Stroke Impact Scale: Hand Subscale
Periodo de tiempo: Baseline, 12 week and 24 week retention
The Stroke Impact Scale (SIS) is a self-report structured interview consisting of eight domains designed to assess changes in impairment, disabilities, and handicap following stroke that contribute to quality of life. It has been tested and found to be reliable, valid, and sensitive to change in the stroke population. There are four physical domains that that can be analyzed separately. The hand domain was analyzed for this study and the scores for this domain range from 0-100. Higher scores indicate greater function.
Baseline, 12 week and 24 week retention

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Christopher T. Bever, MD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

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)

27 de abril de 2011

Finalización primaria (Actual)

16 de enero de 2015

Finalización del estudio (Actual)

30 de enero de 2015

Fechas de registro del estudio

Enviado por primera vez

24 de noviembre de 2010

Primero enviado que cumplió con los criterios de control de calidad

1 de diciembre de 2010

Publicado por primera vez (Estimar)

3 de diciembre de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de octubre de 2019

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

17 de octubre de 2019

Última verificación

1 de octubre de 2019

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. .

Ensayos clínicos sobre Robot Therapy

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