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Effect of Diaphragmatic Breathing Training on Trunk Control and Postural Stability in Individuals With Chronic Stroke

2026年9月9日 更新者:fatma shehata

Effect of Diaphragmatic Breathing Training on Trunk Control and Postural Stability in Individuals With Chronic Stroke: A Randomized Controlled Trial

This randomized controlled trial will investigate whether adding diaphragmatic breathing training to conventional physiotherapy improves trunk control and postural stability in individuals with chronic stroke compared with conventional physiotherapy alone. Forty participants with chronic unilateral stroke will be randomly allocated in a 1:1 ratio to either an experimental group receiving diaphragmatic breathing training plus conventional physiotherapy or a control group receiving conventional physiotherapy alone. The intervention will be provided three times per week for six weeks.

調査の概要

詳細な説明

The study will use a prospective, two-arm, parallel-group randomized controlled design. Forty individuals with chronic unilateral stroke will be recruited and randomly allocated to either an experimental group or a control group in a 1:1 ratio.

The experimental group will receive standard diaphragmatic breathing training in addition to conventional physiotherapy. The control group will receive the same conventional physiotherapy program without diaphragmatic breathing training.

Both groups will receive three treatment sessions per week for six weeks, for a total of 18 sessions.

Trunk control and postural stability will be assessed at baseline and after completion of the six-week intervention. Trunk control will be assessed using the Trunk Impairment Scale, while postural stability will be assessed using the Biodex Balance System. Functional mobility will be assessed using the Timed Up and Go test.

Primary C

研究の種類

介入

入学 (推定)

40

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

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:Adults aged 40-65 years.

  • Clinically diagnosed unilateral stroke.
  • Chronic stroke stage of at least 6 months.
  • Able to sit independently without physical assistance.
  • Able to walk 10 meters with or without an assistive device.
  • Mini-Mental State Examination (MMSE) score ≥24.
  • Modified Ashworth Scale (MAS) score ≤2 in the affected upper and lower limb muscles.
  • Medically stable.
  • Able to understand and follow simple instructions.
  • Willing to participate and provide written informed consent. Exclusion Criteria:Other neurological disorders.
  • Bilateral neurological deficits or multiple deficits substantially interfering with trunk control, balance, or gait.
  • Severe cardiopulmonary disease limiting participation in exercise.
  • Severe musculoskeletal disorders affecting the trunk or lower limbs.
  • Severe cognitive impairment.
  • Severe aphasia preventing understanding of instructions.
  • Significant visual or vestibular impairment affecting balance assessment.
  • Uncontrolled medical conditions.
  • Current participation in another structured rehabilitation program.

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:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Diaphragmatic Breathing Training and Conventional Physiotherapy
Participants will receive conventional physiotherapy combined with standard diaphragmatic breathing training. Diaphragmatic breathing training will involve slow nasal inspiration emphasizing abdominal/lower rib cage expansion, followed by slow controlled oral expiration while minimizing upper chest and shoulder movement. Training will be provided for approximately 10-15 minutes per session, three sessions per week for six weeks.
Standard diaphragmatic breathing training involving slow nasal inspiration with abdominal and lower rib cage expansion, minimal upper chest movement, and slow controlled oral expiration. Participants will perform approximately 10 breaths per set for three sets, with rest periods as needed. Training will be provided for approximately 10-15 minutes per session, three times per week for six weeks.A standardized conventional physiotherapy program including postural alignment and trunk activation, sitting weight-shifting, controlled trunk rotation, sit-to-stand training, standing weight-shifting, static standing balance, and functional mobility/gait training. Treatment will be provided three times per week for six weeks.
アクティブコンパレータ:Conventional Physiotherapy
Participants will receive the same standardized conventional physiotherapy program as the experimental group without diaphragmatic breathing training. Treatment will be provided three sessions per week for six weeks.
Standard diaphragmatic breathing training involving slow nasal inspiration with abdominal and lower rib cage expansion, minimal upper chest movement, and slow controlled oral expiration. Participants will perform approximately 10 breaths per set for three sets, with rest periods as needed. Training will be provided for approximately 10-15 minutes per session, three times per week for six weeks.A standardized conventional physiotherapy program including postural alignment and trunk activation, sitting weight-shifting, controlled trunk rotation, sit-to-stand training, standing weight-shifting, static standing balance, and functional mobility/gait training. Treatment will be provided three times per week for six weeks.

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
Trunk Impairment Scale
時間枠:Baseline (Week 0) and post-intervention (Week 6)
Trunk control will be assessed using the original 17-item Trunk Impairment Scale, which evaluates static sitting balance, dynamic sitting balance, and coordination. Total scores range from 0 to 23, with higher scores indicating better trunk control.
Baseline (Week 0) and post-intervention (Week 6)
Trunk Impairment Scale (TIS)
時間枠:Baseline (Week 0) and post-intervention (Week 6)
Trunk control will be assessed using the original 17-item Trunk Impairment Scale, which evaluates static sitting balance, dynamic sitting balance, and coordination. Total scores range from 0 to 23, with higher scores indicating better trunk control.
Baseline (Week 0) and post-intervention (Week 6)
Biodex Postural Stability
時間枠:Baseline (Week 0) and post-intervention (Week 6)
Postural stability will be assessed using the Biodex Balance System. The selected postural stability index will be recorded under standardized testing conditions, with the same test configuration used at baseline and post-intervention.
Baseline (Week 0) and post-intervention (Week 6)

二次結果の測定

結果測定
メジャーの説明
時間枠
Timed Up and Go (TUG)
時間枠:Baseline (Week 0) and post-intervention (Week 6)
Functional mobility will be assessed using the 3-meter Timed Up and Go test. The time required for the participant to stand up from a chair, walk 3 meters, turn, return to the chair, and sit down will be recorded in seconds. Lower completion time indicates better functional mobility.
Baseline (Week 0) and post-intervention (Week 6)

協力者と研究者

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協力者

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9月1日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2026年12月1日

試験登録日

最初に提出

2026年9月9日

QC基準を満たした最初の提出物

2026年9月9日

最初の投稿 (実際)

2026年9月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月15日

QC基準を満たした最後の更新が送信されました

2026年9月9日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

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

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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