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Combined Cognitive and Gait Training (CogGait)

18 de septiembre de 2018 actualizado por: VA Office of Research and Development
Recent research in gait training for stroke survivors showed that coordinated gait components can be best restored using the following interventions together: coordination exercises, over ground gait training, and body weight supported treadmill training (BWSTT). These results are important because, to the investigators' knowledge, there have been no other reports of the restoration of coordinated gait components for those with persistent gait deficits (> 6 months after stroke). However, a remaining problem was that the restored coordinated gait movements measured in the laboratory did not generalize for many subjects to the everyday environment. The confluence of several factors can cause lack of generalization. First, dual task performance (gait and cognitive attention task) can degrade both gait and attention ability, even in healthy adults. Second, stroke can impair attention. Third, during walking in the everyday environment, attention is required in order to safely process normally occurring stimuli. Therefore, given the success of the new gait training protocol in the lab setting, it is important to address the problems remaining for generalization of the recovered coordinated gait pattern to the everyday environment. The primary hypothesis of this study is that greater gains in gait speed will be produced by combined motor and cognitive training versus motor training alone.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Aim 1, Hypothesis Ia: Comparison of combined motor and cognitive training vs motor training alone. For Aim 1, Hypothesis Ia, this will be a randomized, controlled study. For the two groups, 38 subjects will be enrolled and randomized to either: A) Motor + Cognitive Training; or B) Motor Training alone. Subjects will first be stratified according to coordination and gait deficit severity, as described below. After stratification, the subject will be randomized to one of the two intervention groups for Hypothesis Ia. All the subjects will receive treatment 5 times/week, 3hrs/session, for 12 weeks or for a total of 60 treatment sessions. Group A will receive combined motor and cognitive training; Table 2 (below) shows the graduated approach to providing combined gait and cognitive training. Data collection will be at weeks 1, 6, 12, and 24 (i.e., before, mid-treatment and after treatment, and then 3 months after the end of the treatment protocol. Comparison will be made between the two groups to determine whether there was any additive effectiveness of the cognitive training.

Aim 2, Hypotheses IIa-d: Pre/post-treatment comparisons within Group A, receiving combined motor and cognitive training. For Aim 2, Hypotheses IIa-d, this will be a single cohort pre/post-treatment comparison within Group A receiving combined motor and cognitive training.

Aim 3, Hypotheses IIIa-d: Pre/post-treatment comparisons within Group B, receiving motor training alone. For Aim 3, Hypotheses IIIa-d, this will be a single cohort pre/post-treatment comparison within Group B, receiving motor training alone.

Tipo de estudio

Intervencionista

Inscripción (Actual)

12

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

  • Estados Unidos
    • Florida
      • Gainesville, Florida, Estados Unidos, 32608
        • North Florida/South Georgia Veterans Health System, Gainesville, FL

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:

Stroke Survivor inclusion/exclusion criteria Inclusion Criteria

  • Cognition sufficiently intact to give valid informed consent to participate. *
  • Sufficient endurance to participate in rehabilitation sessions.
  • Ability to follow 2 stage commands.
  • Medically Stable
  • Age > 21 years.
  • Impaired ambulation as follows: inability to flex the knee and ankle in the sagittal plane, in a normal manner so the foot clears the floor; inability to control normal knee angle during single limb weight bearing during stance phase.
  • At least 6 months post stroke.

Able-bodied Inclusion criteria

  • Criteria to be included is that they should be healthy with no history of a neurological disease or orthopedic impairment.**
  • Not Pregnant.
  • No Claustrophobia (only for the sub-sample asked to undergo fMRI.)
  • No counterindications to MR scanning including, pregnancy, weight inappropriate for height, ferrous objects within the body (only for the sub-sample asked to undergo fMRI.)

Exclusion Criteria:

Exclusion Criteria

  • Acute or progressive cardiac, vascular, renal, respiratory, neurological disorders or malignancy.
  • Active psychiatric diagnosis or psychological condition, or active drug/alcohol abuse.
  • Lower motor neuron damage or radiculopathy.
  • Orthopedic impairment. **
  • More than one stroke.
  • Cerebellar dysfunction.
  • Fugl-Meyer lower limb motor sub-score greater than 32.
  • No simultaneous gait rehabilitation participation.
  • Pregnant.
  • Claustrophobia (only for the sub-sample asked to undergo fMRI.)
  • Criteria specific to MR scanning, including pregnancy, weight inappropriate for height, ferrous objects within the body (only for the sub-sample asked to undergo fMRI.)

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Gait plus cognitive training
Rehabilitation of walking/gait, combined with rehabilitation of cognitive function
Conductual: Gait training
Treatment will include coordination exercises and over ground gait training for impaired muscle groups and related gait deficits. The therapy will be provided by a clinical physical therapist specializing in rehabilitation for stroke patients, according to established, conventional guidelines. The protocol was used in the investigators' prior studies, and is designed to restore voluntary control of ankle dorsiflexion during swing phase; hip flexion during swing phase, knee flexion at toe-off, knee flexion during swing phase; knee extension before heel strike; knee control during stance phase; pelvic control during stance phase; and whole body balance control during weight shifting. Newly-learned coordinated movements will be integrated into practice of coordinated gait components. Cognitive rehabilitation will begin with the least difficult aspects of attention control, and progress to the more difficult. Home practice and generalization exercises will be assigned.
Conductual: cognitive training
Cognitive training is designed to enhance attention, intention, executive function, decision making and reaction time. Commercially available computer software will be used, as well as custom cognitive training.
Comparador activo: Gait plus arm training
Rehabilitation of walking/gait, combined with rehabilitation of arm function
Conductual: Gait training
Treatment will include coordination exercises and over ground gait training for impaired muscle groups and related gait deficits. The therapy will be provided by a clinical physical therapist specializing in rehabilitation for stroke patients, according to established, conventional guidelines. The protocol was used in the investigators' prior studies, and is designed to restore voluntary control of ankle dorsiflexion during swing phase; hip flexion during swing phase, knee flexion at toe-off, knee flexion during swing phase; knee extension before heel strike; knee control during stance phase; pelvic control during stance phase; and whole body balance control during weight shifting. Newly-learned coordinated movements will be integrated into practice of coordinated gait components. Cognitive rehabilitation will begin with the least difficult aspects of attention control, and progress to the more difficult. Home practice and generalization exercises will be assigned.
Conductual: Arm training
Treatment will include coordination exercises for reaching and grasping. Activities will include movement of shoulder, elbow, wrist and fingers.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in the Gait Assessment and Intervention (G.A.I.T.) Score
Periodo de tiempo: pre-training (0 weeks), post training (about 12 weeks)
Coordination of walking, scored using the investigators' novel G.A.I.T. measure. This measure evaluated limb and joint movements while participants walk overground at preferred speed. Range of scale: 0 (normal) to 64 (extremely discoordinated gait).
pre-training (0 weeks), post training (about 12 weeks)

Colaboradores e Investigadores

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

Patrocinador

VA Office of Research and Development

Investigadores

  • Investigador principal: Janis J. Daly, PhD MS, North Florida/South Georgia Veterans Health System, Gainesville, FL

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 diciembre de 2013

Finalización primaria (Actual)

1 de junio de 2016

Finalización del estudio (Actual)

1 de junio de 2016

Fechas de registro del estudio

Enviado por primera vez

29 de enero de 2015

Primero enviado que cumplió con los criterios de control de calidad

11 de febrero de 2015

Publicado por primera vez (Estimar)

12 de febrero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de febrero de 2019

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

18 de septiembre de 2018

Última verificación

1 de septiembre de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D7675-R

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Indeciso

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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