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ACL Prehabilitation and Functional Outcomes (ACL Prehab fun)

31 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

76

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Egypte
      • Cairo, Egypte
        • Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Preoperative Prehabilitation Program
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.
Actieve vergelijker: standard preoperative care Control Group
Participants will receive standard preoperative care only without structured prehabilitation program.
Ander: Standard Preoperative Care
Participants receive routine standard preoperative care without structured prehabilitation intervention.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
International Knee Documentation Committee (IKDC) Score
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Beni-Suef University

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 februari 2025

Primaire voltooiing (Werkelijk)

3 september 2025

Studie voltooiing (Werkelijk)

15 maart 2026

Studieregistratiedata

Eerst ingediend

31 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

31 mei 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

31 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FPTBSUREC/0312/15426

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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