Mental Practice Combined With Physical Practice to Improve the Gait Performance of People With Parkinson's Disease
調査の概要
詳細な説明
Background: Among the impairments associated to Parkinson's disease, the gait disturbance is one of which that has the most negative impact on the independence in daily living activities and quality of life of people living with Parkinson's disease. Despite the considerable amount of research, we have no consensus about the most efficient physiotherapeutic approach to improve the gait disturbance. Mental practice is considered an efficient strategy to improve the motor performance in healthy individuals and people with stroke. However, there is scarce evidence about its therapeutic results to improve the gait performance in people living with Parkinson's disease.
Objectives: To investigate the effects of mental gait practice associated with physical practice to improve the gait performance of people living with Parkinson's disease.
Design: Parallel, prospective, double-blind, multicentre randomized clinical trial.
Setting: Brazilian Parkinson Association.
Participants: Twenty-two people living with Parkinson's disease in stages 2-3 of disease evolution according to Hoehn and Yahr Classification.
Interventions: The participants will be randomly allocated in an experimental group and a control group. Both groups will perform 10 individual training sessions, two times per week, for five weeks. The training sessions consist of four blocks of mental practice intercalated with four blocks of physical practice of gait under different conditions. The only difference between the groups will be the content of mental practice blocks: the experimental group will perform mental practice of gait while the control group performs non-gait mental practice.
Randomization: Participants will be randomized by ClinStat software into one of two groups: Experimental Group (EG), which will perform gait mental practice; and Control Group (CG), which will perform the non-gait mental practice.
Statistical analysis: The training effects for each primary and secondary outcome measure will be analyzed for the two training conditions (i.e., control and experimental) at the four assessment time points (i.e., pre-intervention, 7 days post-completion and at 30 and 60-day follow-up) using a mixed-design ANOVA with training as the between-group factor and the assessment time point as the within-group factor. The effect sizes (ES) will be calculated for all comparisons at alpha = 0.05. A Tukey HSD post-hoc test will be used for multiple comparisons and p-values below 5 % will be considered as statistically significant.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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São Paulo、ブラジル、04142-092
- Brazil Parkinson Association
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- diagnosis of Parkinson's disease according to the United Kingdom Brain Bank criteria;
- in stage 2-3 of the disease evolution according to the Hoehn and Yahr;
- treated with levodopa or its synergists;
- capable to walk independently indoors without aid;
- referring 5 years of education or more.
Exclusion Criteria:
- presence of other neurological (excluding PD), orthopedic or cardiopulmonary problems;
- visual and auditory deficiency uncorrected;
- dementia [assessed by Montreal Cognitive Assessment (MoCA), cut-off 26];
- depression [according to the Geriatric Depression Scale (GDS-15), cut-off 6];
- declined imagery capacity [according to the Revised Movement Imagery Questionnaire (MIQ-R) cut-off 10].
研究計画
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：並列代入
- マスキング：ダブル
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：実験グループ (EG)
実験トレーニング (ET) は、シングル (ST) およびデュアルタスク (DT) 条件下で、MP (GMP) の 4 ブロックに歩行身体練習 (GPP) の 4 ブロックを挿入した 10 セッションで構成されます。
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MP の各ブロックは、10 の想像上のステップを含む 5 つの精神的な歩行の試みで構成されます。 参加者は、快適に座り、目を閉じ、4 つの異なる条件で、あからさまな身体動作を行わずに、一人称視点で自分が歩いているところを想像してもらいます。習慣的な速度、できるだけ速く、障害物を乗り越え、名前を覚えています。特定の薬。 PP の各ブロックは、10 歩の 5 回の物理的な歩行試行で構成されます。 参加者は、習慣的な速度、できるだけ速く、障害物を乗り越える、特定の薬の名前を覚えるという 4 つの異なる条件で歩くことが求められます。 |
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アクティブコンパレータ：Control Group
The Control training (CT) consists of 10 sessions with 4 blocks of MP (nGMP) intercalated with 4 blocks of gait physical practice (GPP), under single (ST) and dual-task (DT) conditions.
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MP の各ブロックは、10 の想像上のステップを含む 5 つの精神的な歩行の試みで構成されます。 参加者は、目を閉じて快適に座り、4 つの異なる状況 (馬車の中、熱気球の中、飛行機の中) で、あからさまに身体を動かすことなく、一人称視点で美しい風景を鑑賞している自分を想像してもらいます。ボートとツェペリン飛行船。 PP の各ブロックは、10 歩の 5 回の物理的な歩行試行で構成されます。 参加者は、習慣的な速度、できるだけ速く、障害物を乗り越える、特定の薬の名前を覚えるという 4 つの異なる条件で歩くことが求められます。 |
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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6分間の歩行テスト
時間枠：3ヶ月まで
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6 分間歩行テスト (6-MWT) は、臨床的に推奨される時間を制限したテストであり、参加者は通常の速度で 6 分間、可能な限り長い距離を歩くことが求められます。
必要に応じて休憩のための中断も認められます。
6-MWT は、適切なテスト再テストおよび評価者間の信頼性と、PD で 82 メートルの検出可能な最小限の変化を実証しました。
これは、安全に一人で外を歩くことができるかどうかを予測する良い指標となる可能性があります。
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3ヶ月まで
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Postural Instability and Gait Difficulty Score
時間枠：up to 3 months
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Postural Instability and Gait Difficulty Score (PIGD): This recommended rating scale for evaluation of gait alterations in PD is based on 5 Unified Parkinson's Disease Rating Scale (UPDRS) items relevant to gait and postural instability (items 13-15, 29, and 30).
The 13-15 items are based on gait performance according to PPD perspective, while 29 and 30 items are based on the motor test.
It is a recent rating scale that has been used in PD, evaluated independently, which has adequate clinimetric characteristics.
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up to 3 months
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Dynamic Gait Index
時間枠：up tp 3 months
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The balance during the eight gait related activities is scored in this test.
These include quality of walking speed change, going around and over obstacles and stair walking, as well as the number of steps required for a pivot turn.
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up tp 3 months
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30-second dual task gait
時間枠：up tp 3 months
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It measures the maximal walking distance reached in 30 seconds under single task, i.e., without another concurrent task, and dual task, i.e., with a concurrent cognitive task.
The cognitive task consists of speaking as many words as possible, starting with a specific character (F, S or A), presented at the beginning of test.
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up tp 3 months
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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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Trail Making Test
時間枠：up to 3 months
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This test is constituted with two-timed parts: Part A, which involves a visual-scanning task where the participant is required to draw lines sequentially connecting consecutively numbered circles (1-25) randomly arranged on a page as fast as possible.
Part B, which assesses cognitive flexibility, where the participant is asked to connect the same number of circles in an alternating sequence of numbers and letters (1, A, 2, B, etc.).
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up to 3 months
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39-item Parkinson's Disease Questionnaire
時間枠：up to 3 months
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This scale assesses the health-related quality of life, i.e., the impact of an illness and/or treatment on patients' perception of their status of health and on subjective well-being or satisfaction with life.
It evaluates 39 parameters in eight groups of issues (mobility, ADL, emotional well-being, stigma of the disease, back in the next, cognitive, communication and bodily discomfort).
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up to 3 months
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協力者と研究者
捜査官
- 主任研究者：Maria Elisa P Piemonte, PhD、Department of Physioterapy , Communication Science&Disorders, Occupational Therapy, School of Medicine, University of São Paulo
研究記録日
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最終確認日
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