An interventional study of Mobile App Exercise Program and Supervised Physiotherapy in Anterior Cruciate Ligament (ACL) Rupture, Anterior Cruciate Ligament (ACL) Reconstruction and Anterior Cruciate Ligament (ACL) Injury, sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if using a phone app for exercises is as effective as working with a physical therapist before anterior cruciate ligament knee surgery. It will also check if exercising before surgery helps patients recover better compared to those who do not follow a specific exercise plan. The main questions it aims to answer are:
Researchers will compare the phone app group to a physical therapist group and a group with no specific exercise plan to see which method works best.
Participants will:
This study is a prospective randomized controlled trial designed to investigate the effects of different preoperative rehabilitation methods on patients scheduled for Anterior Cruciate Ligament (ACL) reconstruction.
Participants will be stratified based on their injury type (Isolated ACL injury vs. ACL injury with concomitant meniscus tear) to ensure homogenous distribution. Following stratification, patients will be randomized into three parallel groups using a computer-generated block randomization method (block size of 6).
The study consists of three phases:
Pre-operative Intervention (4 Weeks):
Surgical Intervention:
All participants will undergo ACL reconstruction surgery performed by the same surgical team using hamstring autografts.
Following surgery, ALL patients in all three groups will receive the same standardized, goal based postoperative rehabilitation program. This protocol is based on international criteria and aims to ensure that postoperative care is consistent across all groups, isolating the effect of the preoperative intervention.
Outcomes will be assessed at baseline, preoperatively (after the 4 week program), and 6 months postoperatively. Key assessment methods include:
The primary objective is to determine if the unsupervised digital model is non-inferior to supervised rehabilitation in improving functional outcomes.
78 studies on the registry are indexed under Rupture; 17 are open to participants now.
This study's planned enrollment of 66 is close to the median of 71 across 44 interventional studies indexed under Rupture.
Browse Rupture studies →Dr. Lutfi Kirdar Kartal Training and Research Hospital is the lead sponsor of 78 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a progressive, unsupervised exercise program via a mobile application for 4 weeks prior to surgery. The app provides video guidance, reminders, and compliance tracking.
Behavioral: Mobile App Exercise Program
Participants will undergo a supervised exercise program with a physiotherapist (3 days/week) for 4 weeks prior to surgery. The protocol is identical to the app group.
Behavioral: Supervised Physiotherapy
Participants will receive standard care and will not receive a specific preoperative exercise prescription.
A 4-week progressive home exercise program delivered via a smartphone app. It focuses on range of motion, edema control, strengthening, and balance exercises.
A 4-week in-clinic exercise program supervised by a physiotherapist, including the same exercises as the app group
Isometric Quadriceps Muscle Strength
Muscle strength will be measured using a hand-held dynamometer (Newton). Measurements will be taken at 30 and 70 degrees of knee flexion. The highest value of 3 trials will be recorded.
Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6)
Isometric Hamstring Muscle Strength
Muscle strength will be measured using a hand-held dynamometer (Newton) at 35 and 60 degrees of flexion
Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).
IKDC 2000 Subjective Knee Evaluation Form
A patient-reported outcome measure evaluating knee symptoms and function. Scores range from 0 to 100, with higher scores indicating better function
Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).
Knee Range of Motion (ROM)
Active knee flexion and extension will be measured using a electronic goniometer (degrees)
Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).
Single Leg Hop Test (Limb Symmetry Index)
Participants will hop as far as possible on a single leg. The distance is measured in cm. The Limb Symmetry Index (LSI) will be calculated by comparing the operated leg to the healthy leg.
Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).
Star Excursion Balance Test (SEBT)
Dynamic balance will be assessed by reaching in anterior, posteromedial, and posterolateral directions. Reach distances will be normalized to leg length.
Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).
Active Joint Position Sense
Proprioception will be assessed by the ability to actively reproduce a target angle (15 and 45 degrees) with eyes closed. Absolute angular error will be recorded.
Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).
Knee Effusion (Sweep Test)
Joint effusion will be graded on a scale of 0 to 3+ using the Sweep Test technique
Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).
Exercise Adherence
Adherence will be tracked via the mobile app logs (for the app group) and exercise diaries (for the supervised group). It is defined as the percentage of completed prescribed sessions
Time frame: Preoperative (Week 4).
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.
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Dr. Lutfi Kirdar Kartal Training and Research Hospital