NCT07627724

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 31, 2026

Last Update Submit

May 31, 2026

Conditions

Knee JointAnterior Cruciate Ligament Injury

Keywords

Anterior Cruciate Ligament ReconstructionPreoperative RehabilitationFunctional OutcomesNeuromuscular TrainingStrength TrainingBalance TrainingSingle-Leg Hop TestIKDCKOOS

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively

Secondary Outcomes (3)

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively

  • Tegner Activity Scale

    Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively

  • Single-Leg Hop Test

    Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively

Study Arms (2)

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.

Behavioral: Preoperative Prehabilitation Program

standard preoperative care Control Group

ACTIVE COMPARATOR

Participants will receive standard preoperative care only without structured prehabilitation program.

Other: Standard Preoperative Care

Interventions

Preoperative Prehabilitation ProgramBEHAVIORAL

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.

Prehabilitation program Group
Standard Preoperative CareOTHER

Participants receive routine standard preoperative care without structured prehabilitation intervention.

standard preoperative care Control Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 41803188RESULT

Related Links

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Sahar M Abdelmutilibe, PHD

    Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking is used in this study because the nature of the prehabilitation intervention does not permit blinding of participants or study personnel.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to either a prehabilitation group or a control group and will remain in their assigned group throughout the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy, Beni Suef University

Study Record Dates

First Submitted

May 31, 2026

First Posted

June 4, 2026

Study Start

February 1, 2025

Primary Completion

September 3, 2025

Study Completion

March 15, 2026

Last Updated

June 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations

EG(1)