ファストアーム運動スキルトレーニング (FAST)
高速トレーニングは、小脳媒介の予測フィードフォワード制御により脳卒中後の腕の動きの回復を促進します
調査の概要
詳細な説明
脳卒中生存者の約 65% は、上肢 (UE) 機能の長期的な制限を経験しています。 特に、腕を伸ばす動作の制限が顕著であり、患者の障害レベルと強く相関しています。 日常生活の活動には UE が関与することが多いため、完全な生活の質を取り戻すには、リーチおよび把握スキルを再トレーニングすることが重要です。 しかし、UE 機能の効果的なリハビリテーションに必要なトレーニング パラメータは不明です。 最近の証拠は、トレーニング中の高速動作が慢性脳卒中患者の腕の動きを改善するのに効果的であることを示唆しています。 したがって、大きな誤差を生成する速い動きは、フィードフォワード コントローラーの回復を促進し、慢性脳卒中患者の腕の動きと UE 機能を改善します。 小脳は運動エラーからフィードフォワードコントローラーを学習することに関与しているため、改善は小脳皮質ネットワークの完全性に比例すると考えられます。
脳卒中後の慢性生存者を対象に、二重盲検準ランダム化対照研究が実施される。 参加者は、速度バイアストレーニンググループまたは線量当量精度バイアストレーニンググループ(対照)のいずれかに割り当てられ、訓練を受けた作業療法士または理学療法士により、1週間にわたって4日間のトレーニングを受けます。 行動、EMG、および MRI データは、介入前 2 週間、介入後 3 日、および介入後 1 か月以内に取得されます。
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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California
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Pomona、California、アメリカ、91769
- Casa Colina Hospital and Centers for Healthcare
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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
説明
包含基準:
- 虚血性テント上脳卒中後少なくとも6か月
- 21歳以上
- 麻痺のある UE を動かす残存能力を示す (上肢 Fugl-Meyer 運動スコア >20/66)
- 2 ステップのコマンドに従うことができる (MMSE テストの 8 番目の項目)
- 体幹を拘束した状態で、補助なしで腕を体の前方 25 cm に伸ばす動作を 5 秒以内に実行できる
- 修正アッシュワース スコア < 3 で評価した場合、軽度/中等度以下の痙縮を示す
除外基準:
- 脳卒中以外の神経学的診断
- 神経障害などの末梢運動制限
- 麻痺性UEに影響を与える整形外科疾患
- より影響を受けたUEにおける重度の痛みまたは感覚/固有受容障害
- 視覚無視 (アルバートのテストで 4% 以上の線が交差せずに残った)。
- 小脳に直接影響を与える脳卒中を患った
- MRIスキャンに対する禁忌
- 上肢フグル・マイヤー運動スコア >58/66 の障害はほとんど解決されている
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 |
|---|---|
|
アクティブコンパレータ:スピード重視の複雑な運動スキルのトレーニング
参加者は、1 週間の期間にわたって 4 日間、1 日あたり 400 回の複雑な動きを実行します。
このタスクでは、参加者は幅 5 cm のテーブルの表面に投影された「トラック」内を手を移動する必要があります。
参加者は、移動時間に基づいて適応スコアを受け取ります。 。
|
この介入は、トレーニング中の高速動作が慢性脳卒中患者の腕の動きの改善に効果的であるという最近の一連の証拠に基づいています。参加者は、短時間内に実行された動作に対して報酬が与えられます。
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他の:正確性を重視した複雑な運動スキルのトレーニング
精度に偏ったグループは、精度を重視した線量当量介入を受ける。
テーブル上に投影されたトラックの幅は狭く (2cm 未満)、受け取られる適応スコアはトラックの境界内での精度に基づいています。
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見学のみのグループです。
このグループで受けるトレーニングは、アクティブ グループと同等の量となります。
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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 |
|---|---|---|
|
Change in Arm Reaching Movement Time.
時間枠:Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days
|
Average movement time for 30 planar reaching movements to targets arrayed on a planar workspace.
Negative changes indicate that participants moved faster to the targets following the intervention.
|
Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days
|
|
Change in Movement Smoothness
時間枠:Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days
|
Average movement smoothness for 30 planar reaching movements to target arrayed on a planar workspace.
Smoothness is computed by number of peaks in hand tangential velocity profiles of arm-reaching movements.
Negative changes indicate that participants had smoother movement to the targets following the intervention.
|
Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days
|
|
Change in Speed Accuracy Trade-off
時間枠:Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days
|
The speed-accuracy trade-off of reaching movements was assessed as a linear relationship between movement time and the Index of Difficulty : log ratio of the movement distance to target size.
Negative changes indicate that participants are less affected by the index of difficulty, reflecting a better speed-accuracy trade-off.
|
Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days
|
|
Change in Arm Reaching Movement Time.
時間枠:We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.
|
Average movement time for 30 planar reaching movements to targets arrayed on a planar workspace.
Negative changes indicate that participants moved faster to the targets following the intervention.
|
We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.
|
|
Change in Movement Smoothness
時間枠:We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.
|
Average movement smoothness for 30 planar reaching movements to target arrayed on a planar workspace.
Smoothness is computed by number of peaks in hand tangential velocity profiles of arm-reaching movements.
Negative changes indicate that participants had smoother movement to the targets following the intervention.
|
We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.
|
|
Change in Speed Accuracy Trade-off
時間枠:We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.
|
The speed-accuracy trade-off of reaching movements was assessed as a linear relationship between movement time and the Index of Difficulty : log ratio of the movement distance to target size.
Negative changes indicate that participants are less affected by the index of difficulty, reflecting a better speed-accuracy trade-off.
|
We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Action Research Arm Test (ARAT)
時間枠:Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days
|
The ARAT assesses specific changes in upper limb function among individuals who have sustained a stroke.The test consists of performing functional reaching tasks, with each sub-task scored on a scale from 0 to 3, where a score of 3 indicates the movement was performed normally.
Scores range from 0 to 57, with higher scores indicating better performance.
Positive changes reflect improvements in limb function.
|
Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days
|
|
Change in Upper Extremity Fugl-Meyer (UEFM)
時間枠:Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days
|
The UEFM is a test used to assess sensorimotor impairments in the upper extremity most affected by stroke.
The test consists of performing specific upper extremity movements, with each sub-task scored on a scale from 0 to 2, where a score of 2 indicates normal performance.
Scores range from 0 to 66, with higher scores indicating better performance.
Positive changes reflect improvements in motor function.
|
Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days
|
|
Change in Box and Block Test Score (BBT)
時間枠:Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days
|
The Box and Block Test (BBT) measures unilateral gross manual dexterity.
The test involves moving, one by one, as many blocks as possible from one compartment of a box to an adjacent, identical compartment within 60 seconds.
Scores range from 0 to 150, with higher scores indicating better performance.
Positive changes reflect improvements in upper limb function.
|
Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days
|
|
Change in Action Research Arm Test (ARAT)
時間枠:We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.
|
The ARAT assesses specific changes in upper limb function among individuals who have sustained a stroke.
The test consists of performing functional reaching tasks, with each sub-task scored on a scale from 0 to 3, where a score of 3 indicates the movement was performed normally.
Scores range from 0 to 57, with higher scores indicating better performance.
Positive changes reflect improvements in limb function.
|
We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.
|
|
Change in Upper Extremity Fugl-Meyer (UEFM)
時間枠:We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.
|
The UEFM is a test used to assess sensorimotor impairments in the upper extremity most affected by stroke.
The test consists of performing specific upper extremity movements, with each sub-task scored on a scale from 0 to 2, where a score of 2 indicates normal performance.
Scores range from 0 to 66, with higher scores indicating better performance.
Positive changes reflect improvements in motor function.
|
We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.
|
|
Change in Box and Block Test Score (BBT)
時間枠:We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.
|
The Box and Block Test (BBT) measures unilateral gross manual dexterity.
|
We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.
|
協力者と研究者
協力者
捜査官
- 主任研究者:Nicolas Schweighofer, PhD、University of Southern California
出版物と役立つリンク
一般刊行物
- Winstein C, Kim B, Kim S, Martinez C, Schweighofer N. Dosage Matters. Stroke. 2019 Jul;50(7):1831-1837. doi: 10.1161/STROKEAHA.118.023603. Epub 2019 Jun 5.
- Lang CE, Strube MJ, Bland MD, Waddell KJ, Cherry-Allen KM, Nudo RJ, Dromerick AW, Birkenmeier RL. Dose response of task-specific upper limb training in people at least 6 months poststroke: A phase II, single-blind, randomized, controlled trial. Ann Neurol. 2016 Sep;80(3):342-54. doi: 10.1002/ana.24734. Epub 2016 Aug 16.
- Park H, Kim S, Winstein CJ, Gordon J, Schweighofer N. Short-Duration and Intensive Training Improves Long-Term Reaching Performance in Individuals With Chronic Stroke. Neurorehabil Neural Repair. 2016 Jul;30(6):551-61. doi: 10.1177/1545968315606990. Epub 2015 Sep 24.
- Kantak S, McGrath R, Zahedi N, Luchmee D. Behavioral and neurophysiological mechanisms underlying motor skill learning in patients with post-stroke hemiparesis. Clin Neurophysiol. 2018 Jan;129(1):1-12. doi: 10.1016/j.clinph.2017.10.010. Epub 2017 Nov 8.
- Pantano P, Baron JC, Samson Y, Bousser MG, Derouesne C, Comar D. Crossed cerebellar diaschisis. Further studies. Brain. 1986 Aug;109 ( Pt 4):677-94. doi: 10.1093/brain/109.4.677.
- Kawato M, Gomi H. A computational model of four regions of the cerebellum based on feedback-error learning. Biol Cybern. 1992;68(2):95-103. doi: 10.1007/BF00201431.
- Gribble PL, Ostry DJ. Compensation for interaction torques during single- and multijoint limb movement. J Neurophysiol. 1999 Nov;82(5):2310-26. doi: 10.1152/jn.1999.82.5.2310.
- Maeda RS, Cluff T, Gribble PL, Pruszynski JA. Feedforward and Feedback Control Share an Internal Model of the Arm's Dynamics. J Neurosci. 2018 Dec 5;38(49):10505-10514. doi: 10.1523/JNEUROSCI.1709-18.2018. Epub 2018 Oct 24.
- Darmon Y, Kantak S, Cone H, Fullmer N, Ouellette D, Winstein C, Rosario ER, Schweighofer N. Speed-Biased Training Temporarily Improves Motor Performance of the Paretic Arm Compared to Accuracy-Biased Training in Chronic Stroke Survivors: The Phase 1 FAST Randomized Clinical Trial. Neurorehabil Neural Repair. 2025 Jul;39(7):542-554. doi: 10.1177/15459683251331582. Epub 2025 May 10.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- HS-CG-20-00023
- R21NS120274 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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