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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.
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:
The primary objective is to determine if the unsupervised digital model is non-inferior to supervised rehabilitation in improving functional outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video Based App Group | Experimental | 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. |
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| Supervised Rehabilitation Group | Active Comparator | 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. |
|
| Control Group | No Intervention | Participants will receive standard care and will not receive a specific preoperative exercise prescription. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Baseline, Preoperative (Week 4), and Postoperative (Month 6). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Preoperative (Week 4), and Postoperative (Month 6). |
| Knee Range of Motion (ROM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ömer Hekim, PT, MSc | Contact | +905547538348 | omerfarukhekim@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kartal Dr. Lütfi Kırdar City Hospital | Istanbul | Kartal | 34865 | Turkey (Türkiye) |
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| Supervised Physiotherapy | Behavioral | A 4-week in-clinic exercise program supervised by a physiotherapist, including the same exercises as the app group |
|
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) | 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) | 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 | 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) | 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 | 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). |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
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