- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07627724
ACL Prehabilitation and Functional Outcomes (ACL Prehab fun)
Preoperative Prehabilitation as a Predictor of Improved Functional Outcomes After Anterior Cruciate Ligament Reconstruction
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Cairo, Egypten
- Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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International Knee Documentation Committee (IKDC) Score
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Knee Injury and Osteoarthritis Outcome Score (KOOS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sahar M Abdelmutilibe, PHD, Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FPTBSUREC/0312/15426
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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