Anterior Cruciate Ligament (ACL) RuptureACL-PREHAB-APPNCT07322497
Comparison of Video Based Phone App vs. Supervised Preoperative Exercise for ACL Reconstruction
A study testing Mobile App Exercise Program and Supervised Physiotherapy in people with Anterior Cruciate Ligament (ACL) Rupture and Anterior Cruciate Ligament (ACL) Reconstruction, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Rupture, Anterior Cruciate Ligament (ACL) Reconstruction, Anterior Cruciate Ligament (ACL) Injury
- What is being tested?
- Mobile App Exercise Program and Supervised Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2025to 29 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kartal Dr. Lütfi Kırdar City Hospital
Istanbul, Kartal, 34865
Ömer Hekim, PT, MSc, +905547538348, omerfarukhekim@gmail.com
Engin Eceviz, MD, PhD
About this study
Official title: 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?
Read more
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.
Read the 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:
- 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.
- Conditions
- Anterior Cruciate Ligament (ACL) Rupture, Anterior Cruciate Ligament (ACL) Reconstruction, Anterior Cruciate Ligament (ACL) Injury
- Being tested
- Mobile App Exercise Program, Supervised Physiotherapy
- Keywords
- Preoperative Rehabilitation, ACL Reconstruciton, Prehabilitation, Mobile Application, Telerehabiltiation
- Medical subject headings
- Rupture, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile App Exercise ProgramBehavioural
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 PhysiotherapyBehavioural
A 4-week in-clinic exercise program supervised by a physiotherapist, including the same exercises as the app group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobile App Exercise Program |
| 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. Receives: Behavioral: Supervised Physiotherapy |
| Control Group | No intervention | Participants will receive standard care and will not receive a specific preoperative exercise prescription. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline, Preoperative (Week 4), and Postoperative (Month 6).
Secondary outcomes (7)
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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Preoperative (Week 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start29 Dec 2025
- Primary completion29 Dec 2026 (estimated)
- Study completion29 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament (ACL) RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ömer Hekim, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322497
- Sponsor's protocol ID
- 2025/23/1304
- Acronym
- ACL-PREHAB-APP
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Video Based Physical Exercise and Physiotherapist Supervised Physical Exercise Before Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07322497
- Acronym / sponsor ID
- ACL-PREHAB-APP / 2025/23/1304
- Conditions
- Anterior Cruciate Ligament (ACL) Rupture, Anterior Cruciate Ligament (ACL) Reconstruction, Anterior Cruciate Ligament (ACL) Injury
- Keywords
- Preoperative Rehabilitation, ACL Reconstruciton, Prehabilitation, Mobile Application, Telerehabiltiation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 29 Dec 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Video Based App Group | Experimental | Behavioral: Mobile App Exercise ProgramParticipants 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. |
| Supervised Rehabilitation Group | Active comparator | Behavioral: Supervised PhysiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile App Exercise ProgramA 4-week progressive home exercise program delivered via a smartphone app. It focuses on range of motion, edema control, strengthening, and balance exercises. | Behavioural | Video Based App Group |
| Supervised PhysiotherapyA 4-week in-clinic exercise program supervised by a physiotherapist, including the same exercises as the app group | Behavioural | Supervised Rehabilitation Group |
Primary outcome
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.
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
7 secondary outcomes
IKDC 2000 Subjective Knee Evaluation Form
Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).
Knee Range of Motion (ROM)
Time frame: 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).
Star Excursion Balance Test (SEBT)
Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).
Active Joint Position Sense
Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).
Knee Effusion (Sweep Test)
Time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6).
Exercise Adherence
Time frame: Preoperative (Week 4).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile App Exercise Program and Supervised Physiotherapy in people with Anterior Cruciate Ligament (ACL) Rupture and Anterior Cruciate Ligament (ACL) Reconstruction, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ömer Hekim, PT, MSc (+905547538348, omerfarukhekim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric Quadriceps Muscle Strength (time frame: Baseline, Preoperative (Week 4), and Postoperative (Month 6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.