- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07627724
ACL Prehabilitation and Functional Outcomes (ACL Prehab fun)
Preoperative Prehabilitation as a Predictor of Improved Functional Outcomes After Anterior Cruciate Ligament Reconstruction
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Cairo, Egipt
- Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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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.
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Aktywny komparator: standard preoperative care Control Group
Participants will receive standard preoperative care only without structured prehabilitation program.
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Participants receive routine standard preoperative care without structured prehabilitation intervention.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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International Knee Documentation Committee (IKDC) Score
Ramy czasowe: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
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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.
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Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Knee Injury and Osteoarthritis Outcome Score (KOOS)
Ramy czasowe: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
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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.
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Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
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Tegner Activity Scale
Ramy czasowe: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
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The Tegner Activity Scale is used to evaluate the level of physical activity and return to sports participation in patients after ACL reconstruction.
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Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
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Single-Leg Hop Test
Ramy czasowe: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
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The Single-Leg Hop Test is used to assess functional performance, limb symmetry, and dynamic stability following ACL reconstruction.
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Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Sahar M Abdelmutilibe, PHD, Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- FPTBSUREC/0312/15426
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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