Investigating Therapies for Freezing of Gait
2017年4月24日 更新者：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.
調査の概要
状態
わからない
詳細な説明
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.
研究の種類
介入
入学 (実際)
17
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
Ontario
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Waterloo、Ontario、カナダ、N2L 3C5
- Sun Life Financial Movement Disorders Research and Rehabilitation Centre
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Gait Assessment
時間枠：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
時間枠：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.
|
Change from Baseline at 4 weeks of second treatment phase
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Gait Assessment
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Stroop Test
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Pre-intervention and Post-intervention at week 4 of third 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 third treatment phase
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Parkinson Anxiety Scale
時間枠：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
時間枠：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).
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Pre-intervention and Post-intervention at week 4 of second treatment phase
|
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Parkinson Anxiety Scale
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Rebecca Chow, BSc、Sun Life Financial Movement Disorders Research and Rehabilitation Centre
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年2月24日
一次修了 (予想される)
2017年8月1日
研究の完了 (予想される)
2017年8月1日
試験登録日
最初に提出
2017年2月9日
QC基準を満たした最初の提出物
2017年2月21日
最初の投稿 (実際)
2017年2月27日
学習記録の更新
投稿された最後の更新 (実際)
2017年4月25日
QC基準を満たした最後の更新が送信されました
2017年4月24日
最終確認日
2017年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。