Anterior Cruciate Ligament InjuriesNCT06863610
Knee Extension Deficit Following an Anterior Cruciate Ligament Reconstruction (Extension Loss)
A study testing Extension Deficit (>5 degrees) and Extension Deficit (<5 degrees) in people with Anterior Cruciate Ligament Injuries, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Knee extension loss following an anterior cruciate ligament (ACL) reconstruction is believed to play an important role in quadriceps strength recovery. One of the main goals of the rehabilitation following ACL reconstruction is to restore knee extensor muscle strength. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Extension Deficit (>5 degrees) and Extension Deficit (<5 degrees)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 who underwent ACL repair using hamstring tendon autograft
- volunteered to participate in the study between the ages of 18-45
- a non-contact injury mechanism
- a Tegner Activity Score >5 before the injury
- regularly attended the rehabilitation program after surgery (not missing more than three sessions)
Who cannot join
- Patients who underwent ACL repair with patellar tendon autograft or allograft, revision surgery
- underwent meniscus and or cartilage repair in addition to ACL repair
- a history of previous knee, ankle, or groin injuries
- concomitant systemic and/or neurological pathologies
- a history of injury to the contralateral lower extremity
- do not want to participate in the evaluations that should be done before the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, 06100
About this study
Official title: Investigating the Knee Extension Deficit on Knee Strength Recovery Following an Anterior Cruciate Ligament Reconstruction
Knee extension loss following an anterior cruciate ligament (ACL) reconstruction is believed to play an important role in quadriceps strength recovery. One of the main goals of the rehabilitation following ACL reconstruction is to restore knee extensor muscle strength. Deficits of more than a five-degree extension range of motion (ROM) could lead to delayed knee functionality and anterior knee pain. However, the effect of knee extension deficits in the early postoperative phase of the ACL reconstruction on knee extensor muscle strength recovery and knee functionality is not yet known.
This study aimed to investigate the difference between knee extensor muscle strength recovery and knee functionality in patients with ACL repair who had a knee extension ROM deficit (>5°) in the early postoperative period and those who did not.
Read the detailed description
Knee range of motion deficits are significant surgical complications following an anterior cruciate ligament (ACL) reconstruction, and despite current advances in surgical techniques, knee range of motion cannot always be regained. Previous studies reported that knee range of motion (ROM) deficits play an important role in knee extensor muscle weakness and knee osteoarthritis. Thus, deficits in knee extension joint motion are more difficult to tolerate than flexion deficits. It has been reported that a five-degree decrease in the extension ROM of the affected knee compared to the healthy side can lead to secondary complications such as difficulty walking and anterior knee pain. However, the effect of knee extension deficits in the early postoperative phase of the ACL reconstruction on knee extensor muscle strength recovery and knee functionality is not yet known.
This study aimed to investigate the difference between knee extensor muscle strength recovery and knee functionality in patients with ACL repair who had a knee extension ROM deficit (>5°) in the early postoperative period and those who did not.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Extension Deficit (>5 degrees), Extension Deficit (<5 degrees)
- Keywords
- ACL, reconstruction, knee, extension deficit
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extension Deficit (>5 degrees)Other
Patients who had a knee extension ROM deficit of more than 5 degrees will included
Extension Deficit (<5 degrees)Other
Patients who had a knee extension ROM deficit of less than 5 degrees will included
| Study group | Role | What they receive |
|---|---|---|
| Extension Deficit (>5 degrees) | Experimental | Patients who had a knee extension ROM deficit of more than 5 degrees in the fourth week will be subject to the rehabilitation program under the supervision of the same physiotherapist 3 days a week for a period of 12 weeks. The rehabilitation program will include cold therapy, electrotherapy, and exercises focusing on improving knee functioning and restoring muscle strength. From 12 weeks to 6 months, a home exercise program will be advised to all patients equally. Receives: Other: Extension Deficit (>5 degrees) |
| Extension Deficit (<5 degrees) | Active comparator | Patients who had a knee extension ROM deficit of less than 5 degrees in the fourth week will be subject to the rehabilitation program under the supervision of the same physiotherapist 3 days a week for a period of 12 weeks. The rehabilitation program will include cold therapy, electrotherapy, and exercises focusing on improving knee functioning and restoring muscle strength. From 12 weeks to 6 months, a home exercise program will be advised to all patients equally. Receives: Other: Extension Deficit (<5 degrees) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Muscle Strength Recovery
Isometric, concentric and eccentric quadriceps muscle strength will be measured using an isokinetic dynamometer (IsoMed®2000 D\&R GmbH, Germany).
Measured: Qudriceps muscle strength will be measured at 4th weeks (isometric), 12 th weeks (isometric and concentric), 6th months (isometric, concentric, and eccentric) following a surgery.
Hamstring Muscle Strength Recovery
Isometric, concentric and eccentric hamstring muscle strength will be measured using an isokinetic dynamometer (IsoMed®2000 D\&R GmbH, Germany).
Measured: Hamstring muscle strength will be measured at 4th weeks (isometric), 12 th weeks (isometric and concentric), 6th months (isometric, concentric, and eccentric) following a surgery.
Secondary outcomes (5)
The Y Balance Test. Functional Testing 1
The Y Balance Test will be used. Three repetitions will be conducted for each limb, and mean values were recorded in centimeters.
Measured: Assessments will be conducted at 12th weeks and 6th months following a surgery
The Vertical Jump Test. Functional Testing 2
The Vertical Jump Test will be used. Three repetitions will be conducted for each limb, and mean values were recorded in centimeters.
Measured: Assessments will be conducted at 12th weeks and 6th months following a surgery
The Single Leg Hop Test. Functional Testing 3
The Single Leg Hop Test will be used. Three repetitions will be conducted for each limb, and mean values were recorded in centimeters
Measured: Assessments will be conducted at 12th weeks and 6th months following a surgery
The Lysholm score. Patient-reported outcomes measures 1
The Lysholm score will be used to assess self-reported recovery. The Lysholm score is an eight-item questionnaire that evaluates patients following knee ligament injury. This is scored on a 100-point scale from 0 (worst symptoms) to 100 (best symptoms), with 25 points attributed to pain, 15 to locking, 10 to swelling, 25 to instability,10 to stair climbing and 5 points each to limping, use of a support and squatting.
Measured: Self-reported recovery will be recorded at 12th weeks and 6th months following a surgery
The International Knee Documentation Committee subjective knee form (IKDC). Patient-reported outcomes measures 2
The International Knee Documentation Committee subjective knee form (IKDC) will be used to assess self-reported recovery.
IKDC subjective knee form contains 18 selected items designed to measure symptoms. Total IKDC score ranges from 0 to 100, with 100 indicating the absence of symptoms and higher levels of knee function.
Measured: Self-reported recovery will be recorded at 12th weeks and 6th months following a surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start15 Mar 2025
- Primary completion15 May 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Eraslan, Hacettepe University
- Investigators
- Leyla Eraslan, Ph. D., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863610
- Sponsor's protocol ID
- 2024/140
- Status last verified
- Sep 2025
- First submitted
- 22 Feb 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Knee Extension Deficit on Knee Strength Recovery Following an Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06863610
- Acronym / sponsor ID
- 2024/140
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- ACL, reconstruction, knee, extension deficit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 7 Mar 2025 (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.
Knee extension loss following an anterior cruciate ligament (ACL) reconstruction is believed to play an important role in quadriceps strength recovery. One of the main goals of the rehabilitation following ACL reconstruction is to restore knee extensor muscle strength. Deficits of more than a five-degree extension range of motion (ROM) could lead to delayed knee functionality and anterior knee pain. However, the effect of knee extension deficits in the early postoperative phase of the ACL reconstruction on knee extensor muscle strength recovery and knee functionality is not yet known.
This study aimed to investigate the difference between knee extensor muscle strength recovery and knee functionality in patients with ACL repair who had a knee extension ROM deficit (>5°) in the early postoperative period and those who did not.
Detailed description
Knee range of motion deficits are significant surgical complications following an anterior cruciate ligament (ACL) reconstruction, and despite current advances in surgical techniques, knee range of motion cannot always be regained. Previous studies reported that knee range of motion (ROM) deficits play an important role in knee extensor muscle weakness and knee osteoarthritis. Thus, deficits in knee extension joint motion are more difficult to tolerate than flexion deficits. It has been reported that a five-degree decrease in the extension ROM of the affected knee compared to the healthy side can lead to secondary complications such as difficulty walking and anterior knee pain. However, the effect of knee extension deficits in the early postoperative phase of the ACL reconstruction on knee extensor muscle strength recovery and knee functionality is not yet known.
This study aimed to investigate the difference between knee extensor muscle strength recovery and knee functionality in patients with ACL repair who had a knee extension ROM deficit (>5°) in the early postoperative period and those who did not.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extension Deficit (>5 degrees) | Experimental | Other: Extension Deficit (>5 degrees)Patients who had a knee extension ROM deficit of more than 5 degrees in the fourth week will be subject to the rehabilitation program under the supervision of the same physiotherapist 3 days a week for a period of 12 weeks. The rehabilitation program will include cold therapy, electrotherapy, and exercises focusing on improving knee functioning and restoring muscle strength. From 12 weeks to 6 months, a home exercise program will be advised to all patients equally. |
| Extension Deficit (<5 degrees) | Active comparator | Other: Extension Deficit (<5 degrees)Patients who had a knee extension ROM deficit of less than 5 degrees in the fourth week will be subject to the rehabilitation program under the supervision of the same physiotherapist 3 days a week for a period of 12 weeks. The rehabilitation program will include cold therapy, electrotherapy, and exercises focusing on improving knee functioning and restoring muscle strength. From 12 weeks to 6 months, a home exercise program will be advised to all patients equally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who underwent ACL repair using hamstring tendon autograft
- volunteered to participate in the study between the ages of 18-45
- a non-contact injury mechanism
- a Tegner Activity Score >5 before the injury
- regularly attended the rehabilitation program after surgery (not missing more than three sessions)
Key exclusion criteria (6 listed)
- Patients who underwent ACL repair with patellar tendon autograft or allograft, revision surgery
- underwent meniscus and or cartilage repair in addition to ACL repair
- a history of previous knee, ankle, or groin injuries
- concomitant systemic and/or neurological pathologies
- a history of injury to the contralateral lower extremity
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 |
|---|---|---|
| Extension Deficit (>5 degrees)Patients who had a knee extension ROM deficit of more than 5 degrees will included | Other | Extension Deficit (>5 degrees) |
| Extension Deficit (<5 degrees)Patients who had a knee extension ROM deficit of less than 5 degrees will included | Other | Extension Deficit (<5 degrees) |
Primary outcome
Quadriceps Muscle Strength Recovery
Time frame: Qudriceps muscle strength will be measured at 4th weeks (isometric), 12 th weeks (isometric and concentric), 6th months (isometric, concentric, and eccentric) following a surgery.
Isometric, concentric and eccentric quadriceps muscle strength will be measured using an isokinetic dynamometer (IsoMed®2000 D\&R GmbH, Germany).
Hamstring Muscle Strength Recovery
Time frame: Hamstring muscle strength will be measured at 4th weeks (isometric), 12 th weeks (isometric and concentric), 6th months (isometric, concentric, and eccentric) following a surgery.
Isometric, concentric and eccentric hamstring muscle strength will be measured using an isokinetic dynamometer (IsoMed®2000 D\&R GmbH, Germany).
5 secondary outcomes
The Y Balance Test. Functional Testing 1
Time frame: Assessments will be conducted at 12th weeks and 6th months following a surgery
The Vertical Jump Test. Functional Testing 2
Time frame: Assessments will be conducted at 12th weeks and 6th months following a surgery
The Single Leg Hop Test. Functional Testing 3
Time frame: Assessments will be conducted at 12th weeks and 6th months following a surgery
The Lysholm score. Patient-reported outcomes measures 1
Time frame: Self-reported recovery will be recorded at 12th weeks and 6th months following a surgery
The International Knee Documentation Committee subjective knee form (IKDC). Patient-reported outcomes measures 2
Time frame: Self-reported recovery will be recorded at 12th weeks and 6th months following a surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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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. This study is not recruiting at the moment.
Leyla Eraslan, Ph. D. principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extension Deficit (>5 degrees) and Extension Deficit (<5 degrees) in people with Anterior Cruciate Ligament Injuries, run by Hacettepe University 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 16 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Muscle Strength Recovery (time frame: Qudriceps muscle strength will be measured at 4th weeks (isometric), 12 th weeks (isometric and concentric), 6th months (isometric, concentric, and eccentric) following a surgery.). 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 16 Sep 2026.