- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06863610
Knee Extension Deficit Following an Anterior Cruciate Ligament Reconstruction (Extension Loss)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Leyla Eraslan, Ph. D.
- Phone Number: +905348488373
- Email: leylaseraslan@gmail.com
Study Locations
-
-
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Ankara, Turkey (Türkiye), 06100
- Recruiting
- Hacettepe University, Faculty of Physical Therapy and Rehabilitation
-
Contact:
- Leyla ERASLAN, Prof
- Email: leylaseraslan@gmail.com
-
Contact:
- Volga Bayrakcı Tunay, Prof
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Patients who had a knee extension ROM deficit of more than 5 degrees will included
|
|
Active Comparator: 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.
|
Patients who had a knee extension ROM deficit of less than 5 degrees will included
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Isometric, concentric and eccentric quadriceps muscle strength will be measured using an isokinetic dynamometer (IsoMed®2000 D&R GmbH, Germany).
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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
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).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Y Balance Test. Functional Testing 1
Time Frame: Assessments will be conducted at 12th weeks and 6th months following a surgery
|
The Y Balance Test will be used.
Three repetitions will be conducted for each limb, and mean values were recorded in centimeters.
|
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 Vertical Jump Test will be used.
Three repetitions will be conducted for each limb, and mean values were recorded in centimeters.
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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 Single Leg Hop Test will be used.
Three repetitions will be conducted for each limb, and mean values were recorded in centimeters
|
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 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.
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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
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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. |
Self-reported recovery will be recorded at 12th weeks and 6th months following a surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leyla Eraslan, Ph. D., Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/140
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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