- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06594497
Motor Imagery Training Football Players With Anterior Cruciate Ligament Repair
March 4, 2025 updated by: Kutahya Health Sciences University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Meltem Işıntaş
- Phone Number: +902742652031
- Email: meltem.isintas@ksbu.edu.tr
Study Locations
-
-
-
Kutahya, Turkey, 43100
- Recruiting
- Kütahya Health Sciences University
-
Contact:
- Meltem Isintas
- Phone Number: 02742652031
- Email: meltem.isintas@ksbu.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Physiotherapy group
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).
|
Conventional Physiotherapy
|
|
Experimental: Conventional Physiotherapy + Kinesthetic motor imagery training group
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.
|
Conventional Physiotherapy
Conventional Physiotherapy + Kinesthetic motor imagery training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through study completion, an average of 1 year
|
|
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.
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee Fuctions
Time Frame: Through study completion, an average of 1 year
|
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.
|
Through study completion, an average of 1 year
|
|
Self-confidence Level
Time Frame: Through study completion, an average of 1 year
|
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).
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Meltem Işıntaş, Kütahya Health Sciences University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2024
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
July 31, 2024
First Submitted That Met QC Criteria
September 10, 2024
First Posted (Actual)
September 19, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 4, 2025
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/09-34
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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