Anterior Cruciate Ligament RuptureNCT06831279
Comparison of Two Different Rehabilitation Approaches Applied After Anterior Cruciate Ligament Reconstruction
A study testing EXERCISE in people with Anterior Cruciate Ligament Rupture, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The anterior cruciate ligament is incumbent upon the stabilization of the knee joint in our body. Consequently, it is also of great importance for athletes since it is seen that injuries in clinics are predominantly monitored in young individuals, who do active sports. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- EXERCISE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2024to 30 Jun 2025
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Undergoing anterior cruciate ligament (ACL) reconstruction. Use of hamstring tendon autograft. Age between 18 and 40 years. At least 1 week but no more than 1 year post-surgery.
Who cannot join
- Presence of cardiovascular diseases. Any additional lower extremity disability (e.g., revision ACL reconstruction, other knee surgeries).
- Diagnosis of back or lumbar pain. Any neurological disorders that could affect balance (e.g., epilepsy). Presence of posterior cruciate ligament (PCL) tear in addition to ACL injury.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University
Istanbul, Maltepe, 34854
Gökçe Ünal, 05319449390, gokceharput@gmail.com
Onur Aydoğdu, 05055377277, onur.aydogdu@marmara.edu.tr
About this study
The anterior cruciate ligament is incumbent upon the stabilization of the knee joint in our body. Consequently, it is also of great importance for athletes since it is seen that injuries in clinics are predominantly monitored in young individuals, who do active sports. Anterior cruciate ligament injuries commonly occur in football players when a secondary task (motor or cognitive) is involved while they are busy with a motor activity. In these processes, a circumstance, in which there becomes a quick landing after a jump or a difficult pass whilst dribbling the ball, can be monitored. In such cases, the subject of preventing these injuries, which may occur in athletes, and making them ready for second tasks after the treatment of the injury, has become a current issue. It is important for individuals who have suffered the injury- to be able to bring the knee joint to its former function at the highest level after anterior cruciate ligament reconstruction. As a result, the development of novel rehabilitation strategies has been an ongoing focus of research. A prime exemplar of this phenomenon is the implementation of dual-task exercises. Dual-task exercises appear in athletes as motor-cognitive or motor-motor. Athletes' exercising motor-cognitive functions has attracted the attention of researchers in the past period to prevent injuries in sports and has brought a new breath to the academic world. Studies suggest a decrease in cognitive and motor functions in the acute period after injuries. However, observing its long-term effects, they also suggest an increase in the attention parameter, crucial for athletes.
In a study examining postural stability in individuals, who underwent an operation of anterior cruciate ligament reconstruction by giving motor-motor or motor-cognitive exercises, it is seen that worse results are obtained in postural stability in individuals, who underwent only anterior cruciate ligament reconstruction compared to healthy individuals. Furthermore, in cases -in which eyes were closed and dual motor tasks were given-, more negative results are obtained compared to the open-eyed group. It is associated with a significant decrease in proprioceptive performance in individuals after anterior cruciate ligament injury. Owing to this decrease, postural control decreases, and negative situations arise due to the pathology of the individual. The star balance test is a sensitive test to determine and emerges as an exercise that will correct this negative situation. Post-ACL injury, individuals exhibit significantly lower physical component scores in quality-of-life assessments compared to healthy controls, as reported in books and articles. Moreover, after the ACL reconstruction, a decrease in the mental scores of the individual is seen owing to reasons such as long-term absenteeism from work, rehabilitation, the high costs of the operation, and traumatic occasions.
Read more
Foam roller, one of the current treatment modalities, is a myofascial release technique. The purpose of the foam roller application is to activate myofascial release by using the athlete's body weight and back-and-forth movement cycle. It has been observed that the usage of foam roller delays the emergence of delayed muscle soreness with myofascial release in the quadriceps and hamstring muscles, while also increasing joint range of motion. Despite the widespread utilization of foam rollers in clinical practice, empirical evidence elucidating the underlying mechanisms and clinical efficacy of this modality remains relatively limited. Nevertheless, the factors -which are consequential in the return to pre-injury performance of the athletes- have not been thoroughly scrutinized. For instance, there is no encounter in the literature examining the effects of dual-task exercises on kinesiophobia, ACL-specific quality of life, star balance test evaluation, normal range of motion evaluation, Tegner-Lysholm knee scoring scale.
The purpose of the study is to compare two different rehabilitation groups in terms of pain, range of motion, functionality, balance, quality of life, and kinesiophobia in individuals who underwent ACL reconstruction. The first group is the one with a dual-task approach given during walking and balance exercises together with the conventional physiotherapy program. The latter is the one with the same dual-task approach given during walking and balance exercises together, as an extra with a foam roller.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- EXERCISE
- Keywords
- Anterior Cruciate Ligament, physical therapy, Dual Task, Foam Roller, Balance Exercise
- 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.
EXERCISEOther
Conventional Physiotherapy + Dual-Task Approach During Walking and Balance Exercises:
| Study group | Role | What they receive |
|---|---|---|
| EXERCISE GROUP | Active comparator | Not described Receives: Other: EXERCISE |
| FOAM ROLLER GROUP | Experimental | Bu grupta ek olarak hamstring kas grubuna dinamik şekilde foam roller ile uygulama yapılmıştır. Receives: Other: EXERCISE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Star Excursion Balance Test
Dynamic balance was measured using the Yıldız Balance Test (YBT). Athletes will reach with their feet to the directions of a star drawn on the ground with a 45° angle, resulting in a total of 8 directions. The distance they can reach will be recorded in centimeters.
Prior to the test, athletes will be given 3 minutes to familiarize themselves with the test, and there will be a 2-minute rest between trials. Additionally, a 5-second period will be allowed for the athletes to stand on both feet between each reach. The balance score is calculated using the formula "distance/leg length x 100" (Sitti S., 2013). If a volunteer cannot maintain balance on one foot, falls, pulls their hands away from their waist, or feels pain, the test is terminated.
Measured: At the baseline
Star Excursion Balance Test
Dynamic balance was measured using the Yıldız Balance Test (YBT). Athletes will reach with their feet to the directions of a star drawn on the ground with a 45° angle, resulting in a total of 8 directions. The distance they can reach will be recorded in centimeters.
Prior to the test, athletes will be given 3 minutes to familiarize themselves with the test, and there will be a 2-minute rest between trials. Additionally, a 5-second period will be allowed for the athletes to stand on both feet between each reach. The balance score is calculated using the formula "distance/leg length x 100" (Sitti S., 2013). If a volunteer cannot maintain balance on one foot, falls, pulls their hands away from their waist, or feels pain, the test is terminated.
Measured: Eight week later
Secondary outcomes (9)
Quality of Life Assessment: (ACL-QOL Questionnaire)
ACL-QOL is the only valid and reliable scale that measures the quality of life from the patient's perspective, rather than clinical criteria specific to ACL injuries, and it is available in Turkish. (Kinikli GI., 2015). This test examines 5 main areas with a total of 31 questions: symptoms and physical complaints (4 questions), work-related concerns (4 questions), hobbies, sports, or participation in competitions (12 questions), lifestyle (6 questions), and social and emotional aspects (5 questions).
Measured: At the baseline
Quality of Life Assessment: (ACL-QOL Questionnaire)
ACL-QOL is the only valid and reliable scale that measures the quality of life from the patient's perspective, rather than clinical criteria specific to ACL injuries, and it is available in Turkish. (Kinikli GI., 2015). This test examines 5 main areas with a total of 31 questions: symptoms and physical complaints (4 questions), work-related concerns (4 questions), hobbies, sports, or participation in competitions (12 questions), lifestyle (6 questions), and social and emotional aspects (5 questions).
Measured: Eight week later
Tegner and Lysholm Rating Systems
The Lysholm score was first investigated and developed in the 1970s. The Lysholm rating system is a 100-point scale consisting of 8 different items, with questions specifically related to instability and pain. It has been validated and is reliable in Turkish. (Çelik D., 2013). The Tegner activity score is a system with a scoring range of 0-10, including questions about daily life and sports activities. (Briggs KK., 2006).
Measured: At the baseline
Tegner and Lysholm Rating Systems
The Lysholm score was first investigated and developed in the 1970s. The Lysholm rating system is a 100-point scale consisting of 8 different items, with questions specifically related to instability and pain. It has been validated and is reliable in Turkish. (Çelik D., 2013). The Tegner activity score is a system with a scoring range of 0-10, including questions about daily life and sports activities. (Briggs KK., 2006).
Measured: Eight week later
Range of Motion
The normal range of motion for the knee joint is measured by moving the joint from the starting position of a typical universal goniometer to the end position of the entire range of motion, and recording the number indicated on the goniometer. In this study, a universal goniometer will be used to measure knee joint range of motion for both flexion and extension.
Measured: At the baseline
Range of Motion
The normal range of motion for the knee joint is measured by moving the joint from the starting position of a typical universal goniometer to the end position of the entire range of motion, and recording the number indicated on the goniometer. In this study, a universal goniometer will be used to measure knee joint range of motion for both flexion and extension.
Measured: Eight week later
Pain Scale
Visual Analog Scales (VAS) are psychometric measurement tools that make it possible to quantify the intensity of a symptom as subjectively experienced by individuals. (Klimek, 2017). For pain assessment, a 100 mm paper is provided. One end of the paper is labeled 'no pain - 0' and the other end is labeled 'worst possible pain - 100'. The patient should mark the line according to their condition at the time of the assessment. (Myles et al., 2017). The point where the mark is placed is noted and recorded.
Measured: At the baseline
Pain Scale
Visual Analog Scales (VAS) are psychometric measurement tools that make it possible to quantify the intensity of a symptom as subjectively experienced by individuals. (Klimek, 2017). For pain assessment, a 100 mm paper is provided. One end of the paper is labeled 'no pain - 0' and the other end is labeled 'worst possible pain - 100'. The patient should mark the line according to their condition at the time of the assessment. (Myles et al., 2017). The point where the mark is placed is noted and recorded.
Measured: Eight week later
Tampa Scale for Kinesiophobia (TSK):
Kinesiophobia (fear of movement) was first introduced in 1990 and will be assessed using the Tampa Scale for Kinesiophobia (TSK). (Miller et al., 1991). The TSK is a questionnaire consisting of 17 items designed to assess the fear of re-injury due to a previous trauma. The primary questions address variables related to re-injury, fear, and avoidance of movement in relation to the person's occupation or activities. The TSK uses a Likert scale with 1, 2, 3, and 4 points (1: Strongly Disagree, 4: Strongly Agree). Scores range from 17 to 68. (Huang et al., 2019). A higher score on the scale indicates a higher level of fear of movement. (Demirbuken et al., 2016).
Measured: At the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start30 May 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (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 RuptureStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831279
- Sponsor's protocol ID
- MarmaraU- AYDOĞDU- ÜNAL001
- Status last verified
- May 2024
- First submitted
- 9 Jan 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Rehabilitation Approaches Applied After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06831279
- Acronym / sponsor ID
- MarmaraU- AYDOĞDU- ÜNAL001
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Anterior Cruciate Ligament, physical therapy, Dual Task, Foam Roller, Balance Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 Feb 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.
The anterior cruciate ligament is incumbent upon the stabilization of the knee joint in our body. Consequently, it is also of great importance for athletes since it is seen that injuries in clinics are predominantly monitored in young individuals, who do active sports. Anterior cruciate ligament injuries commonly occur in football players when a secondary task (motor or cognitive) is involved while they are busy with a motor activity. In these processes, a circumstance, in which there becomes a quick landing after a jump or a difficult pass whilst dribbling the ball, can be monitored. In such cases, the subject of preventing these injuries, which may occur in athletes, and making them ready for second tasks after the treatment of the injury, has become a current issue. It is important for individuals who have suffered the injury- to be able to bring the knee joint to its former function at the highest level after anterior cruciate ligament reconstruction. As a result, the development of novel rehabilitation strategies has been an ongoing focus of research. A prime exemplar of this phenomenon is the implementation of dual-task exercises. Dual-task exercises appear in athletes as motor-cognitive or motor-motor. Athletes' exercising motor-cognitive functions has attracted the attention of researchers in the past period to prevent injuries in sports and has brought a new breath to the academic world. Studies suggest a decrease in cognitive and motor functions in the acute period after injuries. However, observing its long-term effects, they also suggest an increase in the attention parameter, crucial for athletes.
In a study examining postural stability in individuals, who underwent an operation of anterior cruciate ligament reconstruction by giving motor-motor or motor-cognitive exercises, it is seen that worse results are obtained in postural stability in individuals, who underwent only anterior cruciate ligament reconstruction compared to healthy individuals. Furthermore, in cases -in which eyes were closed and dual motor tasks were given-, more negative results are obtained compared to the open-eyed group. It is associated with a significant decrease in proprioceptive performance in individuals after anterior cruciate ligament injury. Owing to this decrease, postural control decreases, and negative situations arise due to the pathology of the individual. The star balance test is a sensitive test to determine and emerges as an exercise that will correct this negative situation. Post-ACL injury, individuals exhibit significantly lower physical component scores in quality-of-life assessments compared to healthy controls, as reported in books and articles. Moreover, after the ACL reconstruction, a decrease in the mental scores of the individual is seen owing to reasons such as long-term absenteeism from work, rehabilitation, the high costs of the operation, and traumatic occasions.
Foam roller, one of the current treatment modalities, is a myofascial release technique. The purpose of the foam roller application is to activate myofascial release by using the athlete's body weight and back-and-forth movement cycle. It has been observed that the usage of foam roller delays the emergence of delayed muscle soreness with myofascial release in the quadriceps and hamstring muscles, while also increasing joint range of motion. Despite the widespread utilization of foam rollers in clinical practice, empirical evidence elucidating the underlying mechanisms and clinical efficacy of this modality remains relatively limited. Nevertheless, the factors -which are consequential in the return to pre-injury performance of the athletes- have not been thoroughly scrutinized. For instance, there is no encounter in the literature examining the effects of dual-task exercises on kinesiophobia, ACL-specific quality of life, star balance test evaluation, normal range of motion evaluation, Tegner-Lysholm knee scoring scale.
The purpose of the study is to compare two different rehabilitation groups in terms of pain, range of motion, functionality, balance, quality of life, and kinesiophobia in individuals who underwent ACL reconstruction. The first group is the one with a dual-task approach given during walking and balance exercises together with the conventional physiotherapy program. The latter is the one with the same dual-task approach given during walking and balance exercises together, as an extra with a foam roller.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXERCISE GROUP | Active comparator | Other: EXERCISE |
| FOAM ROLLER GROUP | Experimental | Other: EXERCISEBu grupta ek olarak hamstring kas grubuna dinamik şekilde foam roller ile uygulama yapılmıştır. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Undergoing anterior cruciate ligament (ACL) reconstruction. Use of hamstring tendon autograft. Age between 18 and 40 years. At least 1 week but no more than 1 year post-surgery.
Key exclusion criteria (2 listed)
- Presence of cardiovascular diseases. Any additional lower extremity disability (e.g., revision ACL reconstruction, other knee surgeries).
- Diagnosis of back or lumbar pain. Any neurological disorders that could affect balance (e.g., epilepsy). Presence of posterior cruciate ligament (PCL) tear in addition to ACL injury.
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 |
|---|---|---|
| EXERCISEConventional Physiotherapy + Dual-Task Approach During Walking and Balance Exercises: | Other | EXERCISE GROUP, FOAM ROLLER GROUP |
Primary outcome
Star Excursion Balance Test
Time frame: At the baseline
Dynamic balance was measured using the Yıldız Balance Test (YBT). Athletes will reach with their feet to the directions of a star drawn on the ground with a 45° angle, resulting in a total of 8 directions. The distance they can reach will be recorded in centimeters. Prior to the test, athletes will be given 3 minutes to familiarize themselves with the test, and there will be a 2-minute rest between trials. Additionally, a 5-second period will be allowed for the athletes to stand on both feet between each reach. The balance score is calculated using the formula "distance/leg length x 100" (Sitti S., 2013). If a volunteer cannot maintain balance on one foot, falls, pulls their hands away from their waist, or feels pain, the test is terminated.
Star Excursion Balance Test
Time frame: Eight week later
Dynamic balance was measured using the Yıldız Balance Test (YBT). Athletes will reach with their feet to the directions of a star drawn on the ground with a 45° angle, resulting in a total of 8 directions. The distance they can reach will be recorded in centimeters. Prior to the test, athletes will be given 3 minutes to familiarize themselves with the test, and there will be a 2-minute rest between trials. Additionally, a 5-second period will be allowed for the athletes to stand on both feet between each reach. The balance score is calculated using the formula "distance/leg length x 100" (Sitti S., 2013). If a volunteer cannot maintain balance on one foot, falls, pulls their hands away from their waist, or feels pain, the test is terminated.
9 secondary outcomes
Quality of Life Assessment: (ACL-QOL Questionnaire)
Time frame: At the baseline
Quality of Life Assessment: (ACL-QOL Questionnaire)
Time frame: Eight week later
Tegner and Lysholm Rating Systems
Time frame: At the baseline
Tegner and Lysholm Rating Systems
Time frame: Eight week later
Range of Motion
Time frame: At the baseline
Range of Motion
Time frame: Eight week later
Pain Scale
Time frame: At the baseline
Pain Scale
Time frame: Eight week later
Tampa Scale for Kinesiophobia (TSK):
Time frame: At the baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE in people with Anterior Cruciate Ligament Rupture, run by Marmara 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gökçe Ünal, Physical Therapist (05319449390, gokceharput@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Star Excursion Balance Test (time frame: At the baseline). 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 18 Feb 2025.