Anterior Cruciate Ligament InjuriesNCT06594497
Motor Imagery Training Football Players With Anterior Cruciate Ligament Repair
A study testing Conventional Physiotherapy and Conventional Physiotherapy + Kinesthetic motor imagery training in people with Anterior Cruciate Ligament Injuries, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Volunteer participants who have undergone anterior cruciate ligament surgery at Bursa Çekirge State Hospital and meet the inclusion criteria will be included in the study. The study will select a sample group from the universe using the probability sampling method (simple random sampling). Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Conventional Physiotherapy and Conventional Physiotherapy + Kinesthetic motor imagery training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Sep 2024to Aug 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with anterior cruciate ligament repair,
- Individuals who have no experience in this type of training,
- Not having any vision, hearing, or speech problems that would prevent the tests from being performed.
- Individuals who agree to the purposes of this study and to participate voluntarily.
Who cannot join
- Have previous experience in Motor Imagery techniques or training,
- Having any orthopedic problem that prevents walking,
- Having a history of neurological disease,
- People being treated with any medication that affects the central nervous system
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kutahya Health Sciences University
Kütahya, 43100
Meltem Isintas, 02742652031, meltem.isintas@ksbu.edu.tr
About this study
Official title: The Effect of Motor Imagery Training on Knee Functions and Kinesiophobia in Football Players With Anterior Cruciate Ligament Repair
Volunteer participants who have undergone anterior cruciate ligament surgery at Bursa Çekirge State Hospital and meet the inclusion criteria will be included in the study. The study will select a sample group from the universe using the probability sampling method (simple random sampling). Participants will be divided into 2 groups: Conventional Physiotherapy + Kinesthetic motor imagery training group and Conventional physiotherapy group with randomization software (https://www.randomizer.org/). Conventional physiotherapy practices created by the physician will be applied by physiotherapists working in the hospital. Knee functions will be evaluated with the IKDC scale, reaction time will be assessed with video recording supported by the Kinovea program, kinesiophobia will be assessed with the Tampa kinesiophobia scale, and finally, autonomic functions will be evaluated with the polar device. Measurements will be repeated after 6 weeks of interventions.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Conventional Physiotherapy, Conventional Physiotherapy + Kinesthetic motor imagery training
- 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.
Conventional PhysiotherapyOther
Conventional Physiotherapy
Conventional Physiotherapy + Kinesthetic motor imagery trainingOther
Conventional Physiotherapy + Kinesthetic motor imagery training
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy group | Active comparator | In line with the relevant physician's protocol, Quadriceps Isometric Exercises, Passive ROM exercises, active hip exercises while wearing a brace, ankle exercises, and ice application training are given. The patient is asked to continue as a home program for 2 weeks. After 2 weeks, electrical stimulation (15-20 minutes), current exercises, and ice application continue in the unit. (15min). A total of 30 sessions are applied. In addition, it is requested that the exercises be done at home, as in the treatment program (3x10). Receives: Other: Conventional Physiotherapy |
| Conventional Physiotherapy + Kinesthetic motor imagery training group | Experimental | Motor imagery training will be planned according to the PETTLEP model. A quiet environment will be provided to minimize distractions during the motor imagery session, and the patient's eyes will be closed throughout the session. At the very beginning of the session, a relaxation exercise lasting approximately 2 minutes will be performed to maximize attention during motor imagery. In relaxation exercises, patients will be asked to focus on their breathing, become aware of each body area, and relax the muscles in these areas. Care will be taken to ensure that the imagined movement is of similar duration to the real and optimal movement. Motor imagery will mostly be studied from a first-person perspective. During kinesthetic imagery, people will be asked to feel the movement of their body parts during each exercise without any body movement occurring. 3 sessions per week will last for 6 weeks in total. Receives: Other: Conventional Physiotherapy; Other: Conventional Physiotherapy + Kinesthetic motor imagery training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia
Tampa Kinesiophobia Scale: This scale, consisting of 17 questions, evaluates the person's avoidance of movement or fear of re-injury. A Likert-type scale consisting of 4 points is used. 1 point means 'I disagree', and 4 points means 'I agree'. The individual receives a total score between 17 and 68 on this scale. A high score means high kinesiophobia.
Measured: Through study completion, an average of 1 year
Activity Level
Tegner Activity Scale: Although the scale consists of 11 questions in total, the difficulty level increases as you go from 0 to 10. While 0 means that he is either resting or retired due to his knee problem, 10 means that he is at a level where he can play competitive football at the national and elite levels. The individual is asked to mark the most appropriate one among these 11 items according to his activity level.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Knee Fuctions
IKDC (International Knee Documentation Committee): The IKDC is a purely subjective assessment that assigns patients a functional overall rating. Three categories are examined by the questionnaire: symptoms, athletic activity, and knee function. The symptoms subscale aids in evaluating issues like pain, stiffness, edema, and knee giving way. The stair climbing, standing up from a chair, squatting, and jumping functions are the emphasis of the sports activity subscale. Higher scores indicate higher levels of function and lower levels of symptoms, with the transformed score being regarded as a measure of function.
Measured: Through study completion, an average of 1 year
Self-confidence Level
Athletic Injury Self-Efficacy Questionnaire (AISEQ): The questionnaire comprised 10 items representing 3 types of self-efficacy: task (3 items), barrier (3 items), and scheduling (4 items). Participants rate their self-efficacy for each of the items on a confidence scale ranging from 0% (no confidence) to 100% (completely confident).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Sep 2024
- Primary completionApr 2025 (estimated)
- Study completionAug 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 InjuriesStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meltem Işıntaş, Study director, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594497
- Sponsor's protocol ID
- 2024/09-34
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 5 Mar 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motor Imagery Training on Knee Functions and Kinesiophobia in Football Players With Anterior Cruciate Ligament Repair
- ClinicalTrials.gov ID
- NCT06594497
- Acronym / sponsor ID
- 2024/09-34
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Sep 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.
Volunteer participants who have undergone anterior cruciate ligament surgery at Bursa Çekirge State Hospital and meet the inclusion criteria will be included in the study. The study will select a sample group from the universe using the probability sampling method (simple random sampling). Participants will be divided into 2 groups: Conventional Physiotherapy + Kinesthetic motor imagery training group and Conventional physiotherapy group with randomization software (https://www.randomizer.org/). Conventional physiotherapy practices created by the physician will be applied by physiotherapists working in the hospital. Knee functions will be evaluated with the IKDC scale, reaction time will be assessed with video recording supported by the Kinovea program, kinesiophobia will be assessed with the Tampa kinesiophobia scale, and finally, autonomic functions will be evaluated with the polar device. Measurements will be repeated after 6 weeks of interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy group | Active comparator | Other: Conventional PhysiotherapyIn line with the relevant physician's protocol, Quadriceps Isometric Exercises, Passive ROM exercises, active hip exercises while wearing a brace, ankle exercises, and ice application training are given. The patient is asked to continue as a home program for 2 weeks. After 2 weeks, electrical stimulation (15-20 minutes), current exercises, and ice application continue in the unit. (15min). A total of 30 sessions are applied. In addition, it is requested that the exercises be done at home, as in the treatment program (3x10). |
| Conventional Physiotherapy + Kinesthetic motor imagery training group | Experimental | Other: Conventional Physiotherapy, Other: Conventional Physiotherapy + Kinesthetic motor imagery trainingMotor imagery training will be planned according to the PETTLEP model. A quiet environment will be provided to minimize distractions during the motor imagery session, and the patient's eyes will be closed throughout the session. At the very beginning of the session, a relaxation exercise lasting approximately 2 minutes will be performed to maximize attention during motor imagery. In relaxation exercises, patients will be asked to focus on their breathing, become aware of each body area, and relax the muscles in these areas. Care will be taken to ensure that the imagined movement is of similar duration to the real and optimal movement. Motor imagery will mostly be studied from a first-person perspective. During kinesthetic imagery, people will be asked to feel the movement of their body parts during each exercise without any body movement occurring. 3 sessions per week will last for 6 weeks in total. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals with anterior cruciate ligament repair,
- Individuals who have no experience in this type of training,
- Not having any vision, hearing, or speech problems that would prevent the tests from being performed.
- Individuals who agree to the purposes of this study and to participate voluntarily.
Key exclusion criteria (4 listed)
- Have previous experience in Motor Imagery techniques or training,
- Having any orthopedic problem that prevents walking,
- Having a history of neurological disease,
- People being treated with any medication that affects the central nervous system
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 |
|---|---|---|
| Conventional PhysiotherapyConventional Physiotherapy | Other | Conventional Physiotherapy + Kinesthetic motor imagery training group, Conventional Physiotherapy group |
| Conventional Physiotherapy + Kinesthetic motor imagery trainingConventional Physiotherapy + Kinesthetic motor imagery training | Other | Conventional Physiotherapy + Kinesthetic motor imagery training group |
Primary outcome
Kinesiophobia
Time frame: Through study completion, an average of 1 year
Tampa Kinesiophobia Scale: This scale, consisting of 17 questions, evaluates the person's avoidance of movement or fear of re-injury. A Likert-type scale consisting of 4 points is used. 1 point means 'I disagree', and 4 points means 'I agree'. The individual receives a total score between 17 and 68 on this scale. A high score means high kinesiophobia.
Activity Level
Time frame: Through study completion, an average of 1 year
Tegner Activity Scale: Although the scale consists of 11 questions in total, the difficulty level increases as you go from 0 to 10. While 0 means that he is either resting or retired due to his knee problem, 10 means that he is at a level where he can play competitive football at the national and elite levels. The individual is asked to mark the most appropriate one among these 11 items according to his activity level.
2 secondary outcomes
Knee Fuctions
Time frame: Through study completion, an average of 1 year
Self-confidence Level
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 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. This study is not recruiting at the moment.
Meltem Işıntaş study director
Kutahya Health Sciences 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 Conventional Physiotherapy and Conventional Physiotherapy + Kinesthetic motor imagery training in people with Anterior Cruciate Ligament Injuries, run by Kutahya Health Sciences 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 4 inclusion and 4 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 5 Mar 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 Meltem Işıntaş (+902742652031, meltem.isintas@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia (time frame: Through study completion, an average of 1 year). 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 5 Mar 2025.