- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07627724
ACL Prehabilitation and Functional Outcomes (ACL Prehab fun)
Preoperative Prehabilitation as a Predictor of Improved Functional Outcomes After Anterior Cruciate Ligament Reconstruction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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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Active Comparator: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Knee Documentation Committee (IKDC) Score
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sahar M Abdelmutilibe, PHD, Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPTBSUREC/0312/15426
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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