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ACL Prehabilitation and Functional Outcomes (ACL Prehab fun)

2026年5月31日 更新者:Sahar Mowad Abdelmutilibe、Beni-Suef University

Preoperative Prehabilitation as a Predictor of Improved Functional Outcomes After Anterior Cruciate Ligament Reconstruction

Anterior cruciate ligament (ACL) rupture is a common knee injury that frequently requires surgical reconstruction and extensive postoperative rehabilitation. Preoperative rehabilitation (prehabilitation) has been suggested as a strategy to optimize physical function before surgery and enhance postoperative recovery. This prospective randomized controlled trial aims to evaluate the effectiveness of a structured six-week prehabilitation program on functional outcomes following anterior cruciate ligament reconstruction (ACLR). Seventy-six participants with complete ACL rupture scheduled for primary ACLR were randomly assigned to either a prehabilitation group or a control group receiving standard preoperative care. The prehabilitation program consisted of progressive strengthening exercises, neuromuscular training, balance exercises, and functional movement training performed three times per week. Functional outcomes were assessed at baseline, immediately before surgery, and at three and six months postoperatively using the International Knee Documentation Committee (IKDC) Score, the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Tegner Activity Scale, and the Single-Leg Hop Test. The study aims to determine whether preoperative prehabilitation predicts improved postoperative functional recovery after ACL reconstruction and to provide evidence for optimizing rehabilitation strategies in this patient population.

調査の概要

詳細な説明

Anterior cruciate ligament (ACL) rupture is one of the most common knee injuries among physically active individuals and is frequently managed with ACL reconstruction (ACLR). Despite advances in surgical techniques and postoperative rehabilitation, many patients continue to experience deficits in strength, neuromuscular control, and functional performance after surgery. Optimizing physical function before surgery may contribute to improved postoperative recovery. Preoperative rehabilitation, commonly referred to as prehabilitation, has been proposed as a strategy to enhance muscle strength, improve neuromuscular function, and prepare patients for postoperative rehabilitation. However, evidence regarding its effectiveness in improving functional outcomes following ACL reconstruction remains limited.

This prospective randomized controlled trial was designed to evaluate the impact of a structured six-week prehabilitation program on postoperative functional outcomes in individuals undergoing primary ACL reconstruction. Participants diagnosed with complete ACL rupture and scheduled for surgery were randomly assigned to either a prehabilitation group or a control group receiving standard preoperative care.

The prehabilitation program included progressive strengthening exercises, neuromuscular training, balance training, and functional movement exercises performed three times weekly under supervision. Participants were followed throughout the perioperative period and during postoperative rehabilitation.

Functional recovery was evaluated using validated patient-reported outcome measures and functional performance assessments at predefined time points before and after surgery. The study seeks to determine whether preoperative prehabilitation contributes to superior functional recovery and improved return-to-activity outcomes following ACL reconstruction.

研究の種類

介入

入学 (実際)

76

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

      • Cairo、エジプト
        • Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University

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

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Male and female patients diagnosed with complete anterior cruciate ligament (ACL) rupture.
  • Patients scheduled for primary anterior cruciate ligament reconstruction (ACLR).
  • Age between 18 and 45 years.
  • Medically fit to participate in a preoperative rehabilitation program.
  • Willingness to participate in the study and provide informed consent.
  • Ability to attend preoperative rehabilitation sessions regularly.

Exclusion Criteria:

  • Previous surgery on the affected knee.
  • Multiligament knee injuries other than isolated ACL rupture.
  • Associated fractures around the knee joint.
  • Severe meniscal or cartilage injuries requiring specific surgical management that may affect rehabilitation outcomes.
  • Neurological disorders affecting lower limb function or balance.
  • Systemic diseases that may interfere with rehabilitation (e.g., uncontrolled diabetes, severe cardiovascular disease).
  • Inability to comply with the rehabilitation protocol or follow-up schedule.
  • Refusal or inability to provide informed consent.

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:Prehabilitation program Group
Participants will receive a structured six-week preoperative prehabilitation program including strengthening, neuromuscular training, balance exercises, and functional training three times per week in addition to standard care.
A structured six-week preoperative rehabilitation program including progressive strengthening exercises, neuromuscular training, balance exercises, and functional movement training performed three times per week prior to anterior cruciate ligament reconstruction.
アクティブコンパレータ:standard preoperative care Control Group
Participants will receive standard preoperative care only without structured prehabilitation program.
Participants receive routine standard preoperative care without structured prehabilitation intervention.

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
International Knee Documentation Committee (IKDC) Score
時間枠:Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
The IKDC subjective knee form will be used to assess symptoms, function, and sports activity in patients undergoing ACL reconstruction. Higher scores indicate better knee function.
Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively

二次結果の測定

結果測定
メジャーの説明
時間枠
Knee Injury and Osteoarthritis Outcome Score (KOOS)
時間枠:Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
The KOOS is a patient-reported outcome measure used to assess knee-related symptoms, pain, activities of daily living, sports function, and quality of life following ACL reconstruction.
Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
Tegner Activity Scale
時間枠:Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
The Tegner Activity Scale is used to evaluate the level of physical activity and return to sports participation in patients after ACL reconstruction.
Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
Single-Leg Hop Test
時間枠:Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
The Single-Leg Hop Test is used to assess functional performance, limb symmetry, and dynamic stability following ACL reconstruction.
Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively

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:Sahar M Abdelmutilibe, PHD、Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

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)

2025年2月1日

一次修了 (実際)

2025年9月3日

研究の完了 (実際)

2026年3月15日

試験登録日

最初に提出

2026年5月31日

QC基準を満たした最初の提出物

2026年5月31日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4日

QC基準を満たした最後の更新が送信されました

2026年5月31日

最終確認日

2026年5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

IPD プランの説明

Individual participant data (IPD) will not be shared with other researchers. This decision is made to ensure the confidentiality and privacy of participants, and because the data are collected for academic research purposes within the scope of this study only. Aggregated results will be reported in publications and presentations, but individual-level data will not be made publicly available.

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米国FDA規制機器製品の研究

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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。

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