Cognitive-motor Training for PD
2022年1月14日 更新者：Lisa Muratori、Stony Brook University
The Effects of Dual Task Treadmill Training on Gait and Cognition in Individuals With Parkinson's Disease.
This study will evaluate gait when individuals with Parkinson's disease (PD) are walking and how walking changes when challenged to perform a functional cognitive task simultaneously.
By looking at walking alone and walking with varying cognitive loads the investigators will be able to determine motor and cognitive factors vulnerable to interference in PD.
Each is important to understand so that training can address components of walking that become impaired when someone is distracted by a common cognitive task and so that the intensity of treatment matches the level of task difficulty.
Using this initial data, the investigators will establish a protocol to improve walking taking into account the unique features of PD, including bradykinesia, freezing of gait, stiffness, and problems with memory and attention.
The investigators will evaluate the potential for this treatment to improve walking and improve or maintain cognitive abilities necessary to multitask.
調査の概要
詳細な説明
In this study participants will be asked to participate in a training study to examine whether a new walking intervention that combines cognitive training with walking on a treadmill improves walking more than gait training or cognitive training alone.
Participants with Parkinson's disease (PD) will come to the lab for a complete gait assessment using a motion analysis system that will record leg motion and muscle activity during comfortable walking.
During the initial evaluation, participants will also complete cognitive assessments and surveys about community activities and quality of life related to PD. Participants will be divided into two training groups and asked to come to the lab three times a week for four weeks during the intervention.
One week and one month after training, participants will return to the lab to complete all the same assessments that were performed during the initial visit.
The results of the three testing sessions (initial, one week and one month) will be compared between and within groups to see if any of the interventions provided unique benefits to the health of persons with PD.
研究の種類
介入
入学 (実際)
24
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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New York
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Stony Brook、New York、アメリカ、11794-6018
- Stony Brook University RRAMP Laboratory
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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
21年～80年 (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:
- Clinical diagnosis of Parkinson's disease with our without cognitive impairment
- ambulatory for at least 200 feet without an assistive device (cane, walker, etc)
Exclusion Criteria:
- recent orthopedic injury (e.g., fracture, sprain, muscle pull, herniated disc)
- concurrent neurological illnesses including stroke, brain cancer, spinal cord injury, and diabetic neuropathies.
- cardiac insufficiency limiting ability to participate in walking study
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：Identification of at risk variables
Individuals will come in for a single visit to perform all tasks / conditions.
Measurements will be taken of spatial and temporal features of walking with and without a secondary task.
In addition, cognitive tests of memory and attention will be performed.
Outcomes will narrow measures to those most likely to show clinically significant change.
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Participants will complete walking under three conditions: walking alone for six minutes; standing from a chair, walking 3 meters, turning, and returning to a seated position (TUG); and standing from a chair, walking 3 meters turning and returning to a seated postion while subtracting numbers (TUG Cognitive).
Spatiotemporal measures of gait will be collected.
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実験的：Gait-Cognitive training
Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.
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Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.
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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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Spatiotemporal measures of gait across conditions and over time.
時間枠：Baseline testing at day one of study; follow-up testing at three time periods: 4-5 weeks after baseline (immediate post-training); 5-6 weeks (one week post-training); and 9-10 weeks after baseline (one month post-training)
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Changes in gait parameters are a key measure of the difficulty of performing two tasks at once.
Decreases in gait speed, increased time in double support (two feet on the ground) and stopping while talking have been linked to increased disability and risk for falls.
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Baseline testing at day one of study; follow-up testing at three time periods: 4-5 weeks after baseline (immediate post-training); 5-6 weeks (one week post-training); and 9-10 weeks after baseline (one month post-training)
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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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Changes in cognitive performance measured with serial sevens.
時間枠：Baseline (day one); week 4-5 (immediate post 4 week training program); 5-6 weeks (one-week post-training); 9-10 weeks (one month post-training)
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Participants will count backward by sevens from a digit between 90 and 100.
The ability to perform the task will be used as a measure of cognitive trade-off relative to walking performance.
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Baseline (day one); week 4-5 (immediate post 4 week training program); 5-6 weeks (one-week post-training); 9-10 weeks (one month post-training)
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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
捜査官
- 主任研究者：Lisa M Muratori、Stony Brook University
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)
2020年10月26日
一次修了 (実際)
2021年12月17日
研究の完了 (予想される)
2022年12月15日
試験登録日
最初に提出
2013年7月30日
QC基準を満たした最初の提出物
2013年8月5日
最初の投稿 (見積もり)
2013年8月7日
学習記録の更新
投稿された最後の更新 (実際)
2022年1月18日
QC基準を満たした最後の更新が送信されました
2022年1月14日
最終確認日
2022年1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。