Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
The aim of this study is to compare two physical therapy training consisting of gait training that are distinguished by one being associated with tasks that require handling of the main executive functions, performed by individuals with Parkinson's Disease.
The investigators hypothesis is that the experimental group (EG), which hold gait training with higher cognitive demands (dual-task condition), will make improvements in the parameters measured (functionality of gait and cognitive ability) to a greater extent compared to the control group (CG), which hold gait training without executive tasks (single-task condition).
調査の概要
詳細な説明
The aim of this study is to compare two physical therapy training consisting of a gait training that are distinguished by one being associated with tasks that require handling of the main executive functions (protocol designed by the same team), performed by individuals with Parkinson's Disease.
Both training consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, with the following difference:
- the experimental group (EG) will hold another 30 minutes of gait training in a dual-task condition associated with distracting tasks that require handling of the main executive functions;
- the control group (CG) will hold an additional 30 minutes of gait training without associated tasks.
It will be a prospective study, single blind, randomized, where 30 patients with PD in stages 1 to 3 on Hoehn & Yahr scale will participate in the study, to be held in Brazil Parkinson Association. Patients will be randomized into an experimental and control group, 15 in each one.
The training will consist of 10 sessions, two times per week for five weeks. The executive tasks concomitant with gait training cover the following executive functions: volition, self-awareness, planning, response inhibition, response monitoring and attention.
The main outcome measures are: (1) Dynamic Gait Index (DGI), (2) Montreal Cognitive Assessment (MoCA), (3) Trail Making Test A and B, (4) Unified Parkinson's Disease Rating Scale (UPDRS) and (5) Falls Efficacy Scale (FES).
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
São Paulo、ブラジル
- 募集
- Brazil Parkinson Association
-
コンタクト：
- Grossmann, President
- 電話番号：55-11-25788177
- メール：parkinson@parkinson.org.br
-
主任研究者：
- Cynthia B Ferrari, PhD Student
-
-
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 Idiopathic PD performed by a neurologist specialist in movement disorders;
- In use of dopaminergic medication;
- Disease severity of 1 to 3 according to Hoehn & Yahr scale;
- Absence of other neurological disorders or co-morbidities that may affect gait;
- Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE);
- Vision and hearing adequate or corrected to normal;
- Ability to walk independently;
- Absence of prolonged off state;
- Age 50 to 85 years.
Exclusion Criteria:
- Biomechanical alterations (other pathologies) that could compromise the completion of training;
- Presence of depression, detected by the Geriatric Depression Scale (GDS-15);
- Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during gait training;
- Any changes in drug treatment for PD.
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Gait training executive functions tasks
The experimental group will perform a gait training associated with the tasks that require the main executive functions (dual-task condition).
|
トレーニングは、10 セッション、週 2 回、5 週間で構成され、ストレッチング、筋肉強化、軸可動性エクササイズを含む 30 分間のグローバル エクササイズと、それに関連するデュアルタスク状態での歩行トレーニング 30 分間で構成されます。主な実行機能の処理を必要とする気を散らすタスク: 意欲、自己認識、計画、反応抑制、反応監視および注意。
|
|
アクティブコンパレータ：Gait training alone
The control group will perform a gait training alone, without associated tasks (single-task condition).
|
The training will consist of 10 sessions, two times per week for five weeks, and consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and another 30 minutes of gait training alone, without other tasks.
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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 |
|---|---|---|
|
Dynamic Gait Index
時間枠：05/2013 (Up to ten months)
|
The scale assesses the ability to adapt the gait during motor tasks with different demands.
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05/2013 (Up to ten 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 |
|---|---|---|
|
Montreal Cognitive Assessment
時間枠：05/2013 (Up to ten months)
|
This scale was developed in order to detect mild degrees of cognitive impairment.
The instrument assesses different cognitive domains such as attention and concentration, executive functions, memory, language, visuo-constructive skills, calculations, and orientation.
|
05/2013 (Up to ten months)
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Maria Elisa P Piemonte, PhD、University of Sao Paulo
- 主任研究者：Cynthia B Ferrari, PhD Student、University of Sao Paulo
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
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