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Investigating Therapies for Freezing of Gait

24 de abril de 2017 actualizado por: Rebecca Chow, Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Investigating Therapies for Freezing of Gait Targeting the Cognitive, Limbic, and Sensorimotor Domains

Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by individuals with Parkinson's disease (PD). FOG may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia. Therefore, the purpose of this study is to evaluate cognitive, limbic, and sensorimotor therapies in individuals with FOG. Participants in this study will undergo all three types of treatments in a randomized counterbalanced order. Each treatment will occur in 1 hour sessions, twice weekly for a period of 4 weeks.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by individuals with Parkinson's disease (PD), and negatively impacts quality of life (Walton et al., 2015). Furthermore, advanced FOG does not respond well to treatments commonly used in Parkinson's disease (Nutt et al., 2011), therefore warranting the use of adjunct treatment options. The development of potential treatment strategies for FOG should focus on the underlying mechanism. The cross-talk model of FOG proposes that FOG may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia, resulting in a depletion of dopaminergic resources, leading to FOG (Lewis & Barker, 2009). Hence, based on the cross-talk model, treatments targeting the cognitive, sensorimotor and limbic systems independently may lead to a reduction in FOG episodes. Previous studies have demonstrated the efficacy of therapies targeting these domains in PD and healthy individuals, however, these have yet to be explored in FOG. Therefore, the purpose of this study is to evaluate cognitive, sensorimotor, and limbic therapies in individuals with FOG.

This study will employ a within-subjects design, in which participants will undergo all three treatments in a randomized counterbalanced order. Sessions for each type of treatment will occur for 1 hour, twice weekly for a period of 4 weeks. Participants will also undergo pre- and post-test assessments prior to and following each 4-week treatment period. The cognitive training will utilize the "Smartbrain Pro" computer software, which has previously demonstrated efficacy in individuals with Parkinson's disease (Paris et al., 2011). The sensorimotor training group will participate in proprioceptive training of the upper and lower limbs. This training will entail a target matching task, in which participants will produce active and self-defined movements while blindfolded (i.e. without visual feedback). The limbic training group will undergo cognitive behavioural therapy (CBT) focusing solely on anxiety symptoms.

Tipo de estudio

Intervencionista

Inscripción (Actual)

17

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

  • Canadá
    • Ontario
      • Waterloo, Ontario, Canadá, N2L 3C5
        • Sun Life Financial Movement Disorders Research and Rehabilitation Centre

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Either gender
  • Diagnosed with idiopathic PD by a Neurologist
  • Self-reported FOG with the use of UPDRS-II (Question 14)
  • Confirmation of present FOG by a movement disorder specialist
  • Able to walk 10 meters, unassisted
  • Able to understand English instructions

Exclusion Criteria:

  • A neurological disease other than PD
  • Peripheral neuropathy
  • Clinically diagnosed with dementia

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 cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cognitive Training
Participants will independently complete cognitive exercises on the "Smartbrain Pro" computer software. These exercises aim to train different aspects of executive function. The difficulty level of each exercise will increase relative to each participant's progress. Sessions will last for one hour, occurring twice weekly for a period of 4 weeks.
Conductual: Cognitive Training
Training the cognitive domain may be accomplished by training various cognitive and executive functions with guided practice focusing on specific skills (e.g. visuospatial processing, executive function, memory, language, and attention). Cognitive training has been demonstrated to be efficacious in several studies in individuals with PD. Given the potential cognitive contribution to FOG episodes, this type of therapy may alleviate FOG by potentially improving upon planning, set-shifting, and/or response inhibition.
Experimental: Cognitive Behavioural Therapy
Participants will undergo one-on-one sessions of cognitive-behavioural therapy (CBT) working with a therapist to establish an individualized CBT plan which will focus on symptoms of anxiety. Participants will complete a total of eight one-hour sessions over 4 weeks.
Conductual: Cognitive Behavioural Therapy
CBT has been demonstrated to be effective in the remediation of anxiety in individuals with PD. This may be beneficial to individuals experiencing FOG, given the evidence that anxiety may provoke FOG. During periods of elevated anxiety (e.g. walking in a threatening environment), freezers will be able to more efficiently process this limbic load resulting in greater resources available for movement control.
Experimental: Proprioceptive Training
Participants will complete one-on-one sessions a target matching proprioceptive training protocol using their upper and lower limbs. For the upper limb target-reaching task, participants will be seated in front of a surface marked with ten targets. They will first visualize a specified target, then blindfolded and asked to reach towards that target with the blindfold on. The blindfold will then be removed allowing participants to view their performance relative to the target. This task will be repeated for the remaining targets on both sides and for both upper and lower limbs. Participants will complete a total of eight one-hour sessions over 4 weeks.
Conductual: Proprioceptive Training
Currently, studies investigating proprioceptive training as a treatment in PD are limited. However, this type of training has potential by improving proprioceptive processing. It would be expected that due to this training, when sensorimotor processing is challenged during locomotion (e.g. by removing visual feedback and preventing compensation of proprioception deficits), freezers would experience less decrements to gait due to an enhanced ability to process sensorimotor demands.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gait Assessment
Periodo de tiempo: Change from Baseline at 4 weeks of first treatment phase
Participants will walk approximately 9.75 metres for 12 trials. Recording of kinematic data will be done with eight Optotrak® cameras (Northern Digital, NDI, Waterloo, Ontario). Spatiotemporal gait parameters will be analyzed from this assessment.
Change from Baseline at 4 weeks of first treatment phase
Gait Assessment
Periodo de tiempo: Change from Baseline at 4 weeks of second treatment phase
Participants will walk approximately 9.75 metres for 12 trials. Recording of kinematic data will be done with eight Optotrak® cameras (Northern Digital, NDI, Waterloo, Ontario). Spatiotemporal gait parameters will be analyzed from this assessment.
Change from Baseline at 4 weeks of second treatment phase
Gait Assessment
Periodo de tiempo: Change from Baseline at 4 weeks of third treatment phase
Participants will walk approximately 9.75 metres for 12 trials. Recording of kinematic data will be done with eight Optotrak® cameras (Northern Digital, NDI, Waterloo, Ontario). Spatiotemporal gait parameters will be analyzed from this assessment.
Change from Baseline at 4 weeks of third treatment phase

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Stroop Test
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of first treatment phase
This test assesses inhibitory control and will be administered in a paper-based format.
Pre-intervention and Post-intervention at week 4 of first treatment phase
Trail-making test
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of first treatment phase
This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
Pre-intervention and Post-intervention at week 4 of first treatment phase
Stroop Test
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of second treatment phase
This test assesses inhibitory control and will be administered in a paper-based format.
Pre-intervention and Post-intervention at week 4 of second treatment phase
Trail-making test
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of second treatment phase
This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
Pre-intervention and Post-intervention at week 4 of second treatment phase
Stroop Test
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of third treatment phase
This test assesses inhibitory control and will be administered in a paper-based format.
Pre-intervention and Post-intervention at week 4 of third treatment phase
Trail-making test
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of third treatment phase
This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
Pre-intervention and Post-intervention at week 4 of third treatment phase
Passive Joint Angle Matching
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of first treatment phase
This task will be assessed in order to evaluate proprioceptive functioning.
Pre-intervention and Post-intervention at week 4 of first treatment phase
Passive Joint Angle Matching
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of second treatment phase
This task will be assessed in order to evaluate proprioceptive functioning.
Pre-intervention and Post-intervention at week 4 of second treatment phase
Passive Joint Angle Matching
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of third treatment phase
This task will be assessed in order to evaluate proprioceptive functioning.
Pre-intervention and Post-intervention at week 4 of third treatment phase
Parkinson Anxiety Scale
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of first treatment phase
The Parkinson Anxiety Scale (PAS), which is a self-report questionnaire used to assess anxiety levels, will be administered to participants. This tool has demonstrated good concurrent validity in individuals with PD against other existing anxiety scales (Leentjens et al., 2014).
Pre-intervention and Post-intervention at week 4 of first treatment phase
Parkinson Anxiety Scale
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of second treatment phase
The Parkinson Anxiety Scale (PAS), which is a self-report questionnaire used to assess anxiety levels, will be administered to participants. This tool has demonstrated good concurrent validity in individuals with PD against other existing anxiety scales (Leentjens et al., 2014).
Pre-intervention and Post-intervention at week 4 of second treatment phase
Parkinson Anxiety Scale
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of third treatment phase
The Parkinson Anxiety Scale (PAS), which is a self-report questionnaire used to assess anxiety levels, will be administered to participants. This tool has demonstrated good concurrent validity in individuals with PD against other existing anxiety scales (Leentjens et al., 2014).
Pre-intervention and Post-intervention at week 4 of third treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of first treatment phase
A clinician administered assessment which evaluates individuals' motor symptom severity
Pre-intervention and Post-intervention at week 4 of first treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of second treatment phase
A clinician administered assessment which evaluates individuals' motor symptom severity
Pre-intervention and Post-intervention at week 4 of second treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of third treatment phase
A clinician administered assessment which evaluates individuals' motor symptom severity
Pre-intervention and Post-intervention at week 4 of third treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of first treatment phase
Participants will be asked to complete the New Freezing of Gait Questionnaire (NFOGQ) questionnaire developed by Nieuwboer and colleagues (2009). This provides a self-reported measure of frequency and duration of FOG episodes. This tool has been validated and proven to be highly reliable in individuals with PD, as well as assessing treatment interventions for FOG.
Pre-intervention and Post-intervention at week 4 of first treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of second treatment phase
Participants will be asked to complete the New Freezing of Gait Questionnaire (NFOGQ) questionnaire developed by Nieuwboer and colleagues (2009). This provides a self-reported measure of frequency and duration of FOG episodes. This tool has been validated and proven to be highly reliable in individuals with PD, as well as assessing treatment interventions for FOG.
Pre-intervention and Post-intervention at week 4 of second treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Periodo de tiempo: Pre-intervention and Post-intervention at week 4 of third treatment phase
Participants will be asked to complete the New Freezing of Gait Questionnaire (NFOGQ) questionnaire developed by Nieuwboer and colleagues (2009). This provides a self-reported measure of frequency and duration of FOG episodes. This tool has been validated and proven to be highly reliable in individuals with PD, as well as assessing treatment interventions for FOG.
Pre-intervention and Post-intervention at week 4 of third treatment phase

Colaboradores e Investigadores

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

Patrocinador

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Investigadores

  • Investigador principal: Rebecca Chow, BSc, Sun Life Financial Movement Disorders Research and Rehabilitation Centre

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.

Publicaciones Generales

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)

24 de febrero de 2017

Finalización primaria (Anticipado)

1 de agosto de 2017

Finalización del estudio (Anticipado)

1 de agosto de 2017

Fechas de registro del estudio

Enviado por primera vez

9 de febrero de 2017

Primero enviado que cumplió con los criterios de control de calidad

21 de febrero de 2017

Publicado por primera vez (Actual)

27 de febrero de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de abril de 2017

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

24 de abril de 2017

Última verificación

1 de abril de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • SunLife

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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