Dual Task Training in Parkinson's Disease
2019年11月15日 更新者:Çağrı Gülşen、Gazi University
Effect of Dual Task Training on Balance, Gait, Cognition and Neurotrophic Factors in Parkinson's Disease
The aim of study is to analyze the effects of dual task training on balance, gait, cognition and neurotrophic factors in Parkinson's disease.
調査の概要
詳細な説明
20 patients diagnosed with Parkinson's disease will be randomly assigned to either intervention or control group.
And 10 healty subjects will be included to study in order to determine the reference values.The intervention group will be recieved cognitive and motor dual task training consisting of balance and walking activities 3 days a week for 8 weeks.
Control group will be recieved same balance and walking activities in single task condition 3 days a week for 8 weeks.
In order to evaluate the effects of the training, evaluations will be performed before and after the training period.
研究の種類
介入
入学 (予想される)
20
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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Ankara、七面鳥、06560
- 募集
- Gazi University, Faculty of Health Sciences
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コンタクト:
- Çağrı Gülşen
- 電話番号:05555874415
- メール:fztcagri@gmail.com
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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
40年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- at least 40 years of age
- neurologist-diagnosed Parkinson's Disease
- Hoehn & Yahr (H&Y) stages 1 to 3
- 24 or more mini mental status examination score.
Exclusion Criteria:
- other neurologic disorder
- cardiovascular, inflammatory,vestibular or musculoskeletal problems that could prevent them to participate in an exercise program
- had deep brain stimulation history
- visual, auditory, orientational problems that could affect study results
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: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 |
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実験的:介入グループ
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45 minutes of dual task training consisting of motor activities (walking, balance... etc.) with combination of cognitive activities (spelling words, image description, nomination, word generation, counting... etc.) at sime time.
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アクティブコンパレータ:対照群
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45 minutes of single task training consisting of same motor activities (walking, balance... etc.)
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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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Balance-Postural Stability
時間枠:8 weeks
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Postural Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).. Postural Stability test will performed on both feet and on the left and right foot separately.
Total stability index score will obtained as the test result.
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8 weeks
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Balance- Limits of Stability
時間枠:8 weeks
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Limits of Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).
Limits of Stability test assesses how much the center of gravity is displaced on the support surface without losing balance during the standing position.
Total direction control score will obtained as the test result.
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8 weeks
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Balance- Modified Sensory Organization Tests
時間枠:8 weeks
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Modified Sensory Organization Tests will be evaluated Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).
MSOT assesses the effects of somatosensory, visual and vestibular senses on postural control during the standing position.
It evaluates the sensory component of balance in two different visual conditions and on two different support surfaces; condition 1: eyes open-firm surface, condition 2: eyes closed-firm surface, condition 3: eyes open-foam surface and condition 4: eyes closed-foam surface.
Stability index scores will obtained as the test result.
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8 weeks
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Gait Speed
時間枠:8 weeks
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Gait speed will be evaluated by using the BTS-G Walk system and recorded as m/min.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Cadence
時間枠:8 weeks
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Cadence will be evaluated by using the BTS-G Walk system and recorded as strides/min.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Stride width
時間枠:8 weeks
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Stride width will be evaluated by using the BTS-G Walk system and recorded as meters.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Stride length
時間枠:8 weeks
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Stride length will be evaluated by using the BTS-G Walk system and recorded as meters.
It is a wireless system positioned on L5 vertebrae of the spine.
It allows a functional objective gait analysis to be performed.
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8 weeks
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Montreal Cognitive Assessment (MoCA)
時間枠:8 weeks
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Montreal Cognitive Assessment (MoCA) will be used in order to evaluate cognition.
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.It' score ranged from 0 to 30 and higher points indicates better cognitive outcomes.
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8 weeks
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Change in brain derived neurotrophic factor (BDNF) levels of serum
時間枠:8 weeks
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Brain derived neurotrophic factor (BDNF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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Change in vascular endothelial growth factor (VEGF) levels of serum
時間枠:8 weeks
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Vascular endothelial growth factor (VEGF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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Change in insulin like growth factor 1 (IGF-1) levels of serum
時間枠:8 weeks
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Insulin like growth factor 1 (IGF-1) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.
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8 weeks
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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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Hoehn and Yahr Scale for level of physical disability in Parkinson's disease.
時間枠:8 weeks
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Hoehn and Yahr Scale is measures level of physical disability in Parkinson's disease and stages patients between level 1 level 5. Higher level indicates worse physical condition.
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8 weeks
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Unified Parkinson's Disease Rating Scale (UPDRS)
時間枠:8 weeks
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The Unified Parkinson's Disease Rating Scale (UPDRS) is a widely used measure of impairment and disability associated with Parkinson's Disease (PD) consisting of four sections: (1) Mentation, behavior, and mood; (2) Activities of daily living (ADLs); (3) Motor; and (4) Complications.Sections I through III are scored using a 5-point Likert-type scale (0 = no impairment; 4 = marked impairment).
Although individual sections are scored and reported independently, scores from sections I through III are also summed to provide a UPDRS Total score.
The UPDRS total score ranges between 0 and 199 points.
Higher points indicates worse outcome.
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8 weeks
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Berg Balance Scale (BBS)
時間枠:8 weeks
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Berg Balance Scale (BBS) is a scale that using for assess postural stability.
It ranges 0-56 with higher score indicates better stability.
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8 weeks
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One-legged Stance Test
時間枠:8 weeks
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The duration participant is able to maintain their balance on one leg up to will be recorded.
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8 weeks
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Timed Up and Go (TUG) test
時間枠:8 weeks
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Time in seconds a person needs to stand up from a chair, walk a distance of 3 meters, turn around a flag, come back and sit down again.
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8 weeks
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Activities-Specific Balance Confidence (ABC) Scale
時間枠:8 weeks
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Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady.
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8 weeks
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Stroop Test
時間枠:8 weeks
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Stroop test will be used to test cognitive function.
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8 weeks
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Trail Making Test (TMT) Part A and B
時間枠:8 weeks
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The Trail Making Test is a measure of attention, speed and mental flexibility.
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8 weeks
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Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)
時間枠:8 weeks
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The short-form 8-item Parkinson's disease Questionnaire (PDQ-8) is the most commonly used scale measuring health related quality of life (HRQoL) in PD patients.
It includes 8 items, and each item has five options (never, occasionally, sometimes, often, always or cannot do at all).
The total score ranges from 0 to 32.
Higher scores indicates poorer quality of life.
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8 weeks
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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。
スポンサー
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)
2019年10月16日
一次修了 (予想される)
2021年3月30日
研究の完了 (予想される)
2021年6月30日
試験登録日
最初に提出
2019年9月30日
QC基準を満たした最初の提出物
2019年10月2日
最初の投稿 (実際)
2019年10月4日
学習記録の更新
投稿された最後の更新 (実際)
2019年11月18日
QC基準を満たした最後の更新が送信されました
2019年11月15日
最終確認日
2019年11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。
パーキンソン病の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
Dual Task Trainingの臨床試験
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Medical University of ViennaMedical University of Grazまだ募集していません
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Instituto Nacional de Cardiologia Ignacio Chavezわからない
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Neon HospitalOndokuz Mayıs University完了
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VA Office of Research and Development募集