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Effect of a Semiotically-Optimized Video Education Model on Post-Stroke Rehabilitation (SOVE-Stroke)

2026年7月13日 更新者:Longfei Tao、Xiamen University

A Randomized Controlled Trial Evaluating the Effect of a Semiotically-Optimized Video Education Model on Activities of Daily Living, Sleep Quality, Anxiety, Depression, and Patient Satisfaction in Post-Stroke Rehabilitation Patients

Stroke is a leading cause of death and disability worldwide. Many stroke survivors face difficulties with daily activities, sleep problems, anxiety, and depression during recovery. Health education videos can help patients learn about rehabilitation, but standard videos often contain too much information and are hard for patients to follow. This study aims to test whether using semiotics - the science of signs and symbols - to redesign health education videos can help stroke patients better comprehend and apply rehabilitation instructions. The study is designed to include 200 stroke patients at Siping Central Hospital in Jilin Province, China. Patients will be randomly assigned to either the semiotic-optimized video group or the standard health education video group. Outcome measures, including activities of daily living, sleep quality, anxiety, depression, and satisfaction with care, will be assessed before and after the intervention to evaluate the effectiveness of the optimized video education model.

調査の概要

詳細な説明

Stroke rehabilitation requires patients to acquire and retain complex self-care knowledge, yet cognitive impairments following stroke often limit their ability to process standard verbal and written health education. Conventional video-based education, while beneficial, frequently presents information in ways that overlook patients' cognitive load and perceptual limitations. Semiotic theory - the systematic study of how signs, symbols, and multimodal cues construct meaning - offers a framework for redesigning educational content to enhance comprehension, retention, and behavioral adoption.

This is a randomized controlled trial conducted at the Rehabilitation Department of Siping Central Hospital, with the intervention period scheduled from January to December 2023. The intervention was developed by a multidisciplinary team of eight specialists and nurses from the Rehabilitation and Neurology Departments. Twenty-two educational videos were produced across three domains: rehabilitation science, exercise guidance, and dietary advice. Each video averaged five to eight minutes in duration. In the experimental group, videos were redesigned using semiotic principles: key rehabilitation actions were highlighted through local magnification with bold, red subtitles and auditory cues; incorrect postures were filmed and contrasted with correct demonstrations using comparative visual cues; and a curated music library was integrated to support relaxation and sleep. Video feedback techniques were also employed, including on-site assessment of movement accuracy and post-training questioning to evaluate knowledge retention. The intervention was delivered twice daily under nursing supervision throughout the 28-day inpatient rehabilitation period.

The control group received standard care with the same set of rehabilitation videos delivered through routine face-to-face guidance, without semiotic optimization or structured video feedback. The primary objective is to evaluate whether the semiotically-optimized video education model can improve activities of daily living compared to standard video education. Secondary objectives will assess changes in sleep quality, anxiety, depression, and patient satisfaction.

研究の種類

介入

入学 (実際)

200

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

    • Jilin
      • Siping、Jilin、中国、136000
        • Siping Central People's Hospital

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:

  1. Imaging-confirmed cerebral infarction per 2019 Chinese Guidelines
  2. Age ≥18 years
  3. Stable condition during rehabilitation phase
  4. Alert, able to comprehend and operate video playback
  5. Signed informed consent

Exclusion Criteria:

  1. Incomplete records, inaccurate data, or failure to complete the intervention

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:支持療法
  • 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
実験的:Experimental: Semiotically-Optimized Video Group
Participants received semiotically-optimized video-based health education, 28 days, twice daily, 5-8 minutes per session, including music and video feedback.
Participants received semiotically-optimized video-based health education, 28 days, twice daily, 5-8 minutes per session, including music and video feedback.
アクティブコンパレータ:Active Comparator: Standard Video Group
Participants received standard video-based health education, 28 days, routine rehabilitation instructional videos and assistive device guidance.
Participants received standard video-based health education, 28 days, routine rehabilitation instructional videos and assistive device guidance.

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 Activities of Daily Living (ADL)
時間枠:Baseline and Day 28
Modified Barthel Index (MBI), The MBI comprises 10 items assessing ADL, with a total score ranging from 0 to 100. Higher scores indicate better independence in daily living activities.
Baseline and Day 28

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Sleep Quality
時間枠:Baseline and Day 28
Pittsburgh Sleep Quality Index (PSQI), The PSQI consists of 18 items assessing sleep quality over a one-month interval. The global score ranges from 0 to 21. Lower scores indicate better sleep quality, whereas higher scores indicate worse sleep quality.
Baseline and Day 28
Change in Anxiety
時間枠:Baseline and Day 28
Beck Anxiety Inventory (BAI), The BAI consists of 21 self-report items, with a total score ranging from 0 to 63. Higher scores indicate more severe anxiety.
Baseline and Day 28
Change in Depression
時間枠:Baseline and Day 28
Chinese Version of the Beck Depression Inventory, 2nd edition (BDI-Ⅱ-C), The BDI-II-C consists of 21 items assessing depressive symptoms, with a total score ranging from 0 to 63. Higher scores indicate more severe depression.
Baseline and Day 28
Patient Satisfaction
時間枠:Day 28
Self-developed Inpatient Satisfaction Questionnaire, The questionnaire consists of 10 items rated on a 5-point Likert scale, yielding a total score ranging from 10 to 50. Higher scores indicate better patient satisfaction.
Day 28

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:Yang Liu, PhD、Xiamen 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)

2023年1月1日

一次修了 (実際)

2023年12月31日

研究の完了 (実際)

2023年12月31日

試験登録日

最初に提出

2026年7月8日

QC基準を満たした最初の提出物

2026年7月13日

最初の投稿 (実際)

2026年7月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月17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13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

その他の研究ID番号

  • SOVE-2023-001
  • XMSHLXH2320 (その他の助成金/資金番号:Xiamen Nursing Association)
  • 2024038 (その他の助成金/資金番号:Siping City Science and Technology Development Plan)

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米国FDA規制機器製品の研究

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