Investigating Therapies for Freezing of Gait
24 de abril de 2017 atualizado 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.
Visão geral do estudo
Status
Desconhecido
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
17
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ontario
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Waterloo, Ontario, Canadá, N2L 3C5
- Sun Life Financial Movement Disorders Research and Rehabilitation Centre
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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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.
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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.
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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.
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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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Gait Assessment
Prazo: Change from Baseline at 4 weeks of first treatment phase
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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.
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Change from Baseline at 4 weeks of first treatment phase
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Gait Assessment
Prazo: Change from Baseline at 4 weeks of second treatment phase
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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.
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Change from Baseline at 4 weeks of second treatment phase
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Gait Assessment
Prazo: Change from Baseline at 4 weeks of third treatment phase
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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.
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Change from Baseline at 4 weeks of third treatment phase
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Stroop Test
Prazo: Pre-intervention and Post-intervention at week 4 of first treatment phase
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This test assesses inhibitory control and will be administered in a paper-based format.
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Pre-intervention and Post-intervention at week 4 of first treatment phase
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Trail-making test
Prazo: Pre-intervention and Post-intervention at week 4 of first treatment phase
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This will also be administered in a paper-based format.
This test will assess visuospatial function and set-shifting ability.
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Pre-intervention and Post-intervention at week 4 of first treatment phase
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Stroop Test
Prazo: 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
Prazo: 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
|
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Stroop Test
Prazo: 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
|
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Trail-making test
Prazo: 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.
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Pre-intervention and Post-intervention at week 4 of third treatment phase
|
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Passive Joint Angle Matching
Prazo: Pre-intervention and Post-intervention at week 4 of first treatment phase
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This task will be assessed in order to evaluate proprioceptive functioning.
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Pre-intervention and Post-intervention at week 4 of first treatment phase
|
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Passive Joint Angle Matching
Prazo: Pre-intervention and Post-intervention at week 4 of second treatment phase
|
This task will be assessed in order to evaluate proprioceptive functioning.
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Pre-intervention and Post-intervention at week 4 of second treatment phase
|
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Passive Joint Angle Matching
Prazo: Pre-intervention and Post-intervention at week 4 of third treatment phase
|
This task will be assessed in order to evaluate proprioceptive functioning.
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Pre-intervention and Post-intervention at week 4 of third treatment phase
|
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Parkinson Anxiety Scale
Prazo: Pre-intervention and Post-intervention at week 4 of first treatment phase
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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).
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Pre-intervention and Post-intervention at week 4 of first treatment phase
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Parkinson Anxiety Scale
Prazo: 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
|
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Parkinson Anxiety Scale
Prazo: 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).
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Pre-intervention and Post-intervention at week 4 of third treatment phase
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Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Prazo: Pre-intervention and Post-intervention at week 4 of first treatment phase
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A clinician administered assessment which evaluates individuals' motor symptom severity
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Pre-intervention and Post-intervention at week 4 of first treatment phase
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Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Prazo: Pre-intervention and Post-intervention at week 4 of second treatment phase
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A clinician administered assessment which evaluates individuals' motor symptom severity
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Pre-intervention and Post-intervention at week 4 of second treatment phase
|
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Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Prazo: Pre-intervention and Post-intervention at week 4 of third treatment phase
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A clinician administered assessment which evaluates individuals' motor symptom severity
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Pre-intervention and Post-intervention at week 4 of third treatment phase
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New Freezing of Gait Questionnaire (NFOGQ)
Prazo: Pre-intervention and Post-intervention at week 4 of first treatment phase
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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.
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Pre-intervention and Post-intervention at week 4 of first treatment phase
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New Freezing of Gait Questionnaire (NFOGQ)
Prazo: 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.
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Pre-intervention and Post-intervention at week 4 of second treatment phase
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New Freezing of Gait Questionnaire (NFOGQ)
Prazo: 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.
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Pre-intervention and Post-intervention at week 4 of third treatment phase
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Investigadores
- Investigador principal: Rebecca Chow, BSc, Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
24 de fevereiro de 2017
Conclusão Primária (Antecipado)
1 de agosto de 2017
Conclusão do estudo (Antecipado)
1 de agosto de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
9 de fevereiro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de fevereiro de 2017
Primeira postagem (Real)
27 de fevereiro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de abril de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de abril de 2017
Última verificação
1 de abril de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SunLife
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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