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Investigating Therapies for Freezing of Gait

24 апреля 2017 г. обновлено: 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.

Обзор исследования

Статус

Неизвестный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

17

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок
  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Назначение кроссовера
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Поведенческий: 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.
Экспериментальный: 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.
Поведенческий: 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.
Экспериментальный: 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.
Поведенческий: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Gait Assessment
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Stroop Test
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Следователи

  • Главный следователь: Rebecca Chow, BSc, Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

24 февраля 2017 г.

Первичное завершение (Ожидаемый)

1 августа 2017 г.

Завершение исследования (Ожидаемый)

1 августа 2017 г.

Даты регистрации исследования

Первый отправленный

9 февраля 2017 г.

Впервые представлено, что соответствует критериям контроля качества

21 февраля 2017 г.

Первый опубликованный (Действительный)

27 февраля 2017 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

25 апреля 2017 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

24 апреля 2017 г.

Последняя проверка

1 апреля 2017 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • SunLife

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

Нет

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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