Anterior Cruciate Ligament ReconstructionNCT06538792
Proprioception, Muscle Strength and Kinesiophobia After Anterior Cruciate Ligament Reconstruction
An observational study of Anterior Cruciate Ligament Reconstruction, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Fear of re-injury after anterior cruciate ligament reconstruction surgery (ACLR) affects individuals' return to sports and physical activity negatively. The aim of this study is to evaluate the effects of proprioception and muscle strength on kinesiophobia in patients who have undergone anterior cruciate ligament… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Nov 2024to Jun 2026
- Phase
- Observational
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who have undergone ACL reconstruction surgery will be recruited from the Department of the Orthopaedics and Traumatology, Bezmialem Vakıf University Hospital.
Who may be able to join
- Between the ages of 18-35
- History of ACL reconstruction surgery at least 6 months ago
Who cannot join
- History of previous lower extremity surgery
- History of lower extremity injury within the last 6 months
- Having a vestibular or neurologic pathology that would affect balance
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
Bezmialem Vakif University
Istanbul
Kubra Alpay, PhD, kubraalpay@hotmail.com
İldeniz Yalnız, MSc
About this study
Official title: Effect of Proprioception and Muscle Strength on Kinesiophobia After Anterior Cruciate Ligament Reconstruction
Fear of re-injury after anterior cruciate ligament reconstruction surgery (ACLR) affects individuals' return to sports and physical activity negatively. The aim of this study is to evaluate the effects of proprioception and muscle strength on kinesiophobia in patients who have undergone anterior cruciate ligament reconstruction surgery.
Read the detailed description
Factors such as graft type, patient age, activity level and athletic experience, as well as psychological factors such as psychological readiness for return to sports, fear of re-injury, and motivation during the rehabilitation process, affect returning to sports after ACLR. Fear is a psychological reaction that occurs after injury and is clearly seen during the period when athletes continue to actively participate in sports. Individuals' confidence in their knees and pain after surgery affect their fear of movement.
While kinesiophobia provides benefits in protecting injured body parts in the acute phase of pain, it can lead to inactivity, emotional stress and risk of re-injury in the long term. Kinesiophobia changes the biomechanics of movements and pain perception. Insufficient muscle strength and instability in the knee negatively affect confidence in the knee. The aim of this study is to evaluate the effects of proprioception and muscle strength on kinesiophobia in patients who have undergone anterior cruciate ligament reconstruction surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia
The Tampa Kinesiophobia Scale consists of seventeen items. Scores obtained from the scale range from 17 to 68, with higher scores indicating greater severity of kinesiophobia.
Measured: Baseline
Joint position sense
Measurement of knee joint position sense by the active and passive repositioning technique with isokinetic dynamometer at 30˚ and 60˚.The deviation from the target angle is recorded in degrees. A high deviation from the target angle indicates a deficiency in proprioceptive sense.
Measured: Baseline
Muscle strength
Assessment for knee extensor and flexor muscles with isokinetic dynamometer at 60 º/sec and 240º/sec angular velocity. The peak torque value (Nm), which is measured by the device and indicates the maximum force the subject can reach, will be used in the assessment.
Measured: Baseline
Dynamic stability
The single leg dynamic stability test by the Biodex Balance System® (Biodex Medical Systems, Inc. USA). Low values of the stability index indicate better balance and stability, while higher scores indicate a lower ability to maintain postural stability.
Measured: Baseline
Secondary outcomes (1)
Return to sports after ACL injury
The ACL Return to Sports after Injury (ACL-RSI) scale is a 12-item scale, scored from 0 to 10, that evaluates psychological readiness for return to sports after ACL injury. High scores indicate positive psychological readiness.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start9 Nov 2024
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (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 ReconstructionStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Alpay, Bezmialem Vakif University
- Investigators
- Kubra Alpay, PhD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538792
- Sponsor's protocol ID
- Ka24-2
- Status last verified
- Jul 2025
- First submitted
- 1 Aug 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proprioception and Muscle Strength on Kinesiophobia After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06538792
- Acronym / sponsor ID
- Ka24-2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 9 Nov 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 6 Aug 2024 (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.
Fear of re-injury after anterior cruciate ligament reconstruction surgery (ACLR) affects individuals' return to sports and physical activity negatively. The aim of this study is to evaluate the effects of proprioception and muscle strength on kinesiophobia in patients who have undergone anterior cruciate ligament reconstruction surgery.
Detailed description
Factors such as graft type, patient age, activity level and athletic experience, as well as psychological factors such as psychological readiness for return to sports, fear of re-injury, and motivation during the rehabilitation process, affect returning to sports after ACLR. Fear is a psychological reaction that occurs after injury and is clearly seen during the period when athletes continue to actively participate in sports. Individuals' confidence in their knees and pain after surgery affect their fear of movement.
While kinesiophobia provides benefits in protecting injured body parts in the acute phase of pain, it can lead to inactivity, emotional stress and risk of re-injury in the long term. Kinesiophobia changes the biomechanics of movements and pain perception. Insufficient muscle strength and instability in the knee negatively affect confidence in the knee. The aim of this study is to evaluate the effects of proprioception and muscle strength on kinesiophobia in patients who have undergone anterior cruciate ligament reconstruction surgery.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who have undergone ACL reconstruction surgery will be recruited from the Department of the Orthopaedics and Traumatology, Bezmialem Vakıf University Hospital.
Key inclusion criteria (2 listed)
- Between the ages of 18-35
- History of ACL reconstruction surgery at least 6 months ago
Key exclusion criteria (3 listed)
- History of previous lower extremity surgery
- History of lower extremity injury within the last 6 months
- Having a vestibular or neurologic pathology that would affect balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kinesiophobia
Time frame: Baseline
The Tampa Kinesiophobia Scale consists of seventeen items. Scores obtained from the scale range from 17 to 68, with higher scores indicating greater severity of kinesiophobia.
Joint position sense
Time frame: Baseline
Measurement of knee joint position sense by the active and passive repositioning technique with isokinetic dynamometer at 30˚ and 60˚.The deviation from the target angle is recorded in degrees. A high deviation from the target angle indicates a deficiency in proprioceptive sense.
Muscle strength
Time frame: Baseline
Assessment for knee extensor and flexor muscles with isokinetic dynamometer at 60 º/sec and 240º/sec angular velocity. The peak torque value (Nm), which is measured by the device and indicates the maximum force the subject can reach, will be used in the assessment.
Dynamic stability
Time frame: Baseline
The single leg dynamic stability test by the Biodex Balance System® (Biodex Medical Systems, Inc. USA). Low values of the stability index indicate better balance and stability, while higher scores indicate a lower ability to maintain postural stability.
1 secondary outcome
Return to sports after ACL injury
Time frame: Baseline
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 10 Jul 2025.
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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.
Kubra Alpay, PhD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Reconstruction, run by Bezmialem Vakif 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 2 inclusion and 3 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 10 Jul 2025. 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 Kubra Alpay, PhD (+902124012600 ext. 4638, kubraalpay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia (time frame: Baseline). The study lists 4 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 10 Jul 2025.