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NCT Number: NCT07322497

Comparison of Video Based Phone App vs. Supervised Preoperative Exercise for ACL Reconstruction

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:

* Does the phone app help patients improve their knee strength and movement as well as seeing a physical therapist? * Do patients who exercise before surgery have a better recovery after surgery than those who do not?

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:

* Follow an exercise plan for 4 weeks before their surgery (either using the app, with a therapist, or no specific plan). * Visit the clinic for check-ups before starting the exercises, right before the surgery, and 6 months after the surgery. * Complete simple tests and surveys to measure their knee health.

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Key information

Conditions

Anterior Cruciate Ligament (ACL) Rupture Anterior Cruciate Ligament (ACL) Injury Anterior Cruciate Ligament (ACL) Reconstruction Rupture Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Kartal, 34865, Turkey (Türkiye)

Location contact

Engin Eceviz, MD, PhD

PRINCIPAL_INVESTIGATOR

Zuhal Didem Takinacı, PT, PhD

SUB_INVESTIGATOR

Ömer Hekim, PT, MSc

CONTACT

[email protected]

+905547538348

Ömer Hekim, PT, MSc

SUB_INVESTIGATOR

About this study

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):
  • Video Based Mobile Application Group (Unsupervised): Participants will follow a progressive exercise program via a mobile app. The app provides asynchronous video guidance, reminders, and compliance tracking. The program focuses on range of motion, edema reduction, and muscle strengthening.
  • Supervised Rehabilitation Group: Participants will undergo the exact same exercise protocol under the direct supervision of a physiotherapist (3 sessions/week) in a clinical setting.
  • Control Group: Participants will receive standard care without a specific structured exercise prescription.
  • Surgical Intervention:

All participants will undergo ACL reconstruction surgery performed by the same surgical team using hamstring autografts.

  • Post-operative Rehabilitation:

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:

  • Isometric muscle strength testing (Quadriceps and Hamstring) using a hand-held dynamometer.
  • Functional performance assessment via Single Leg Hop Tests (limb symmetry index).
  • Proprioception evaluation using active joint position sense tests.
  • Knee range of motion measurement with a electronic goniometer.
  • Patient-reported outcomes using the IKDC 2000 Subjective Knee Evaluation Form.

The primary objective is to determine if the unsupervised digital model is non-inferior to supervised rehabilitation in improving functional outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosed unilateral Anterior Cruciate Ligament (ACL) rupture
  • Patients scheduled for ACL reconstruction surgery.
  • Age between 18 and 45 years.
  • Patients willing to participate and sign the informed consent form.

Exclusion criteria

  • Patients with multiple ligament injuries (e.g., combined ACL and PCL/MCL injury).
  • Patients with bilateral ACL injuries.
  • Presence of accompanying fractures around the knee joint.
  • Presence of active infection.
  • Patients who refuse surgery or withdraw consent.

Treatment and study plan

Mobile App Exercise Program

Behavioral

A 4-week progressive home exercise program delivered via a smartphone app. It focuses on range of motion, edema control, strengthening, and balance exercises.

Supervised Physiotherapy

Behavioral

A 4-week in-clinic exercise program supervised by a physiotherapist, including the same exercises as the app group

Primary outcomes

  1. Isometric Quadriceps Muscle Strength

    Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6)

    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.

  2. Isometric Hamstring Muscle Strength

    Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).

    Muscle strength will be measured using a hand-held dynamometer (Newton) at 35 and 60 degrees of flexion

Secondary outcomes

  1. IKDC 2000 Subjective Knee Evaluation Form

    Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).

    A patient-reported outcome measure evaluating knee symptoms and function. Scores range from 0 to 100, with higher scores indicating better function

  2. Knee Range of Motion (ROM)

    Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).

    Active knee flexion and extension will be measured using a electronic goniometer (degrees)

  3. Single Leg Hop Test (Limb Symmetry Index)

    Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).

    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.

  4. Star Excursion Balance Test (SEBT)

    Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).

    Dynamic balance will be assessed by reaching in anterior, posteromedial, and posterolateral directions. Reach distances will be normalized to leg length.

  5. Active Joint Position Sense

    Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).

    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.

  6. Knee Effusion (Sweep Test)

    Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).

    Joint effusion will be graded on a scale of 0 to 3+ using the Sweep Test technique

  7. Exercise Adherence

    Time frame: Preoperative (Week 4).

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ömer Hekim, PT, MSc

CONTACT

[email protected]

+905547538348

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

Investigation of the Effects of Video Based Physical Exercise and Physiotherapist Supervised Physical Exercise Before Anterior Cruciate Ligament Reconstruction

Acronym: ACL-PREHAB-APP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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