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ACL Prehabilitation and Functional Outcomes (ACL Prehab fun)

31 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

76

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comparador Ativo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
International Knee Documentation Committee (IKDC) Score
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

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

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de fevereiro de 2025

Conclusão Primária (Real)

3 de setembro de 2025

Conclusão do estudo (Real)

15 de março de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

31 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de maio de 2026

Primeira postagem (Real)

4 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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