Anterior Cruciate Ligament InjuryACL Prehab funNCT07627724
ACL Prehabilitation and Functional Outcomes
A study testing Preoperative Prehabilitation Program and Standard Preoperative Care in people with Anterior Cruciate Ligament Injury and Knee Joint, run by Beni-Suef University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Knee Joint
- What is being tested?
- Preoperative Prehabilitation Program and Standard Preoperative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University
Cairo
About this study
Official title: 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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injury, Knee Joint
- Being tested
- Preoperative Prehabilitation Program, Standard Preoperative Care
- Keywords
- Anterior Cruciate Ligament Reconstruction, Preoperative Rehabilitation, Functional Outcomes, Neuromuscular Training, Strength Training, Balance Training, Single-Leg Hop Test, IKDC, KOOS
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Prehabilitation ProgramBehavioural
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.
Standard Preoperative CareOther
Participants receive routine standard preoperative care without structured prehabilitation intervention.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation program Group | Experimental | 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. Receives: Behavioral: Preoperative Prehabilitation Program |
| standard preoperative care Control Group | Active comparator | Participants will receive standard preoperative care only without structured prehabilitation program. Receives: Other: Standard Preoperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee (IKDC) Score
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.
Measured: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
Secondary outcomes (3)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
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.
Measured: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
Tegner Activity Scale
The Tegner Activity Scale is used to evaluate the level of physical activity and return to sports participation in patients after ACL reconstruction.
Measured: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
Single-Leg Hop Test
The Single-Leg Hop Test is used to assess functional performance, limb symmetry, and dynamic stability following ACL reconstruction.
Measured: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Feb 2025
- Primary completion3 Sep 2025
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either a prehabilitation group or a control group and will remain in their assigned group throughout the study.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Mowad Abdelmutilibe, Beni-Suef University
- Investigators
- Sahar M Abdelmutilibe, PHD, Principal investigator, Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627724
- Sponsor's protocol ID
- FPTBSUREC/0312/15426
- Acronym
- ACL Prehab fun
- Status last verified
- May 2026
- First submitted
- 31 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Abel R, Niederer D, Glowa A, Hansen N, Wilke C, Offerhaus C. Effectiveness of exercise prehabilitation before anterior cruciate ligament reconstruction on functional outcomes - a single-blinded randomized controlled trial. Sci Rep. 2026 Mar 9;16(1):8962. doi: 10.1038/s41598-026-41576-2.
PubMed 41803188
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Prehabilitation as a Predictor of Improved Functional Outcomes After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07627724
- Acronym / sponsor ID
- ACL Prehab fun / FPTBSUREC/0312/15426
- Conditions
- Anterior Cruciate Ligament Injury, Knee Joint
- Keywords
- Anterior Cruciate Ligament Reconstruction, Preoperative Rehabilitation, Functional Outcomes, Neuromuscular Training, Strength Training, Balance Training, Single-Leg Hop Test, IKDC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to either a prehabilitation group or a control group and will remain in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation program Group | Experimental | Behavioral: Preoperative Prehabilitation ProgramParticipants 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. |
| standard preoperative care Control Group | Active comparator | Other: Standard Preoperative CareParticipants will receive standard preoperative care only without structured prehabilitation program. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Prehabilitation ProgramA 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. | Behavioural | Prehabilitation program Group |
| Standard Preoperative CareParticipants receive routine standard preoperative care without structured prehabilitation intervention. | Other | standard preoperative care Control Group |
Primary outcome
International Knee Documentation Committee (IKDC) Score
Time frame: 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.
3 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
Tegner Activity Scale
Time frame: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
Single-Leg Hop Test
Time frame: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Results publication: PubMed 41803188Abel R, Niederer D, Glowa A, Hansen N, Wilke C, Offerhaus C. Effectiveness of exercise prehabilitation before anterior cruciate ligament reconstruction on functional outcomes - a single-blinded randomized controlled trial. Sci Rep. 2026 Mar 9;16(1):8962. doi: 10.1038/s41598-026-41576-2.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Related trials for Anterior Cruciate Ligament Injury
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BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
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Preventing Injured Knees From osteoArthritis: Severity Outcomes
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahar M Abdelmutilibe, PHD principal investigator
Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Prehabilitation Program and Standard Preoperative Care in people with Anterior Cruciate Ligament Injury and Knee Joint, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC) Score (time frame: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07627724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.