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Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke

2026年7月21日 更新者：Emrah Zirek、Istanbul University - Cerrahpasa

High-Repetition Task-Oriented Training Versus High-Intensity Gait Training for Lower Extremity Rehabilitation in Individuals With Chronic Stroke: An Assessor-Blinded Randomized Controlled Trial

The purpose of this study is to compare the effects of high-repetition task-oriented training and high-intensity gait training on walking capacity and functional mobility in individuals with chronic stroke.

Forty-five participants will be randomly assigned to one of three groups: (1) neurodevelopmental treatment (NDT) alone, (2) NDT combined with high-repetition task-oriented training, or (3) NDT combined with high-intensity gait training. All participants will receive treatment 3 days per week for 8 weeks (24 sessions in total). Walking capacity (6-Minute Walk Test) and functional mobility (Timed Up and Go Test, modified Dynamic Gait Index, 10-Meter Walk Test) will be assessed before and after the intervention by an assessor blinded to group allocation. The study hypothesizes that adding structured, intensity-based training approaches to conventional NDT will lead to greater improvements in walking capacity than NDT alone.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Stroke is a leading cause of long-term disability worldwide, and impaired walking capacity remains one of the most common and persistent limitations in the chronic phase. Although neurodevelopmental treatment (NDT) is widely used in clinical practice, current evidence emphasizes the role of training intensity and task-specific repetition in promoting locomotor recovery. However, comparative evidence regarding the relative effectiveness of high-repetition task-oriented training and high-intensity gait training as adjuncts to conventional therapy in chronic stroke is limited.

This study is designed as an assessor-blinded, three-arm, parallel-group randomized controlled trial. Forty-five individuals with chronic stroke will be randomly allocated in a 1:1:1 ratio to one of three groups (n=15 per group): (1) NDT alone, consisting of 45-minute sessions; (2) NDT combined with high-repetition task-oriented training; or (3) NDT combined with high-intensity gait training. In the combined groups, an additional 30 minutes of the respective training approach will be delivered in each session, resulting in approximately 75 minutes of total treatment time per session. All interventions will be delivered by a single experienced physiotherapist, 3 days per week for 8 weeks (24 sessions in total), at Bingöl State Hospital and the Faculty of Physiotherapy and Rehabilitation of Bingöl University.

The primary outcome is walking capacity assessed with the 6-Minute Walk Test. Secondary outcomes include the Timed Up and Go Test, the modified Dynamic Gait Index, and the 10-Meter Walk Test. All outcome measures will be administered at baseline and at the end of the 8-week intervention period by an independent assessor blinded to group allocation.

Data will be analyzed using repeated-measures analysis of variance to examine time-by-group interaction effects. The study is expected to provide comparative evidence to inform the selection of intensity-based adjunct training strategies in the rehabilitation of walking function in chronic stroke.

研究の種類

介入

入学 (推定)

45

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。

研究連絡先

  • 名前：Emrah Zirek, Ph. D.
  • 電話番号：+904262160012
  • メール：zireke@gmail.com

研究連絡先のバックアップ

研究場所

  • トルコ（Türkiye）
    • Center
      • Bingoel、Center、トルコ（Türkiye）、12000
        • Bingol State Hospital - City: Bingöl, Country: Türkiye (listede "Turkey" olarak geçebilir), Zip: 12000
        • コンタクト：

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Diagnosis of first-ever unilateral stroke (ischemic or hemorrhagic) confirmed by clinical and/or radiological findings
  • Time since stroke onset of at least 6 months (chronic phase)
  • Age between 18 and 75 years
  • Ability to walk at least 10 meters independently, with or without an assistive device
  • Functional Ambulation Category (FAC) score of 3 or higher
  • Sufficient cognitive ability to understand and follow instructions (Mini-Mental State Examination score ≥ 24)
  • Willingness to participate and provision of written informed consent

Exclusion Criteria:

  • Recurrent stroke or bilateral hemispheric involvement
  • Unstable cardiovascular disease or other medical conditions contraindicating high-intensity exercise
  • Severe lower extremity spasticity interfering with gait training (Modified Ashworth Scale score > 3)
  • Orthopedic, rheumatological, or other neurological conditions affecting gait
  • Severe visual or vestibular impairment
  • Severe aphasia or cognitive impairment preventing participation in training or assessments
  • Participation in another structured rehabilitation or exercise program during the study period
  • Botulinum toxin injection to the lower extremity within the last 6 months

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
アクティブコンパレータ：Group 1: Neurodevelopmental Treatment (NDT)
Participants will receive neurodevelopmental treatment alone, delivered in 45-minute sessions, 3 days per week for 8 weeks (24 sessions in total).
他の：Neurodevelopmental Treatment
Conventional neurodevelopmental treatment delivered in 45-minute sessions, 3 days per week for 8 weeks, focusing on postural control, weight transfer, selective movement of the lower extremity, and facilitation of normal movement patterns. All sessions will be delivered by a single experienced physiotherapist.
他の名前：
  • NDT
実験的：Group 2: NDT + High-Repetition Task-Oriented Training
Participants will receive 45 minutes of neurodevelopmental treatment followed by 30 minutes of high-repetition task-oriented training targeting the lower extremity in each session (approximately 75 minutes in total), 3 days per week for 8 weeks (24 sessions in total).
他の：High-Repetition Task-Oriented Training
Structured, task-specific lower extremity training performed at high repetition volumes for 30 minutes per session, in addition to neurodevelopmental treatment. Training includes functional tasks such as sit-to-stand, stepping, and weight-shifting activities, with the number of repetitions and task difficulty progressed individually based on participant performance.
他の名前：
  • HRTOT
実験的：Group 3: NDT + High-Intensity Gait Training
Participants will receive 45 minutes of neurodevelopmental treatment followed by 30 minutes of high-intensity gait training in each session (approximately 75 minutes in total), 3 days per week for 8 weeks (24 sessions in total).
他の：High-Intensity Gait Training
Walking-based training performed for 30 minutes per session at high aerobic intensity, in addition to neurodevelopmental treatment. Training intensity will be progressively adjusted and monitored using target heart rate and ratings of perceived exertion.
他の名前：
  • HIGT

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
6-Minute Walk Test (6MWT)
時間枠：8 weeks
The 6-Minute Walk Test measures the distance (in meters) a participant can walk in 6 minutes along a standardized walkway. Greater distance indicates better walking capacity. The test will be administered by an assessor blinded to group allocation.
8 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Modified Dynamic Gait Index (mDGI)
時間枠：8 weeks
The modified Dynamic Gait Index evaluates the ability to modify gait in response to changing task demands across 8 tasks, each scored on three facets (time, level of assistance, and gait pattern). Total scores range from 0 to 64, with higher scores indicating better dynamic gait performance.
8 weeks
10-Meter Walk Test (10MWT)
時間枠：8 weeks
The 10-Meter Walk Test measures gait speed (in meters per second) over a 10-meter distance. Higher speed indicates better walking performance.
8 weeks

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

Istanbul University - Cerrahpasa

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 (推定)

2026年8月15日

一次修了 (推定)

2026年12月15日

研究の完了 (推定)

2026年12月15日

試験登録日

最初に提出

2026年7月21日

QC基準を満たした最初の提出物

2026年7月21日

最初の投稿 (実際)

2026年7月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月24日

QC基準を満たした最後の更新が送信されました

2026年7月21日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • BINGOL-FTR-2026-05-09

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?

いいえ

IPD プランの説明

Individual participant data will not be shared publicly due to institutional data protection regulations and the terms of the ethics committee approval, which do not include consent for public data sharing. De-identified data may be made available from the principal investigator upon reasonable request.

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