Comparison of Video Based Phone App vs. Supervised Preoperative Exercise for ACL Reconstruction (ACL-PREHAB-APP)

December 22, 2025 updated by: Ömer Hekim, Dr. Lutfi Kirdar Kartal Training and Research Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  1. 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.

  2. Surgical Intervention:

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

  3. 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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Kartal
      • Istanbul, Kartal, Turkey (Türkiye), 34865
        • Kartal Dr. Lütfi Kırdar City Hospital
        • Contact:
        • Principal Investigator:
          • Engin Eceviz, MD, PhD
        • Sub-Investigator:
          • Zuhal Didem Takinacı, PT, PhD
        • Sub-Investigator:
          • Ömer Hekim, PT, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video Based App Group
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
A 4-week progressive home exercise program delivered via a smartphone app. It focuses on range of motion, edema control, strengthening, and balance exercises.
Active Comparator: Supervised Rehabilitation Group
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
A 4-week in-clinic exercise program supervised by a physiotherapist, including the same exercises as the app group
No Intervention: Control Group
Participants will receive standard care and will not receive a specific preoperative exercise prescription.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Preoperative (Week 4), and Postoperative (Month 6)
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
Baseline, Preoperative (Week 4), and Postoperative (Month 6).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Preoperative (Week 4), and Postoperative (Month 6).
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)
Baseline, Preoperative (Week 4), and Postoperative (Month 6).
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.
Baseline, Preoperative (Week 4), and Postoperative (Month 6).
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.
Baseline, Preoperative (Week 4), and Postoperative (Month 6).
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.
Baseline, Preoperative (Week 4), and Postoperative (Month 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
Baseline, Preoperative (Week 4), and Postoperative (Month 6).
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
Preoperative (Week 4).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 29, 2025

Primary Completion (Estimated)

December 29, 2026

Study Completion (Estimated)

December 29, 2027

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/23/1304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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