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IRCT20231113060048N1 IRCT 2023-12-28 Shahid Beheshti University of Medical Sciences The increasing effect of transcranial direct current stimulation of the motor cortex to routine physical therapy on quadriceps muscle strength in athletes with anterior cruciate ligament reconstruction surgery The increasing effect of transcranial direct current stimulation of the motor cortex to routine physical therapy on quadriceps muscle strength in athletes with anterior cruciate ligament reconstruction surgery: a double-blind randomized clinical trial. 2024-01-10 anticipated 20 Complete https://irct.ir/trial/73733 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: It seems that the measurement of central activation ratio in athletes with anterior cruciate ligament surgery in the acute phase (two months after surgery) will be done for the first time, Blinding description: Randomization is done in such a way that qualified and available people are placed random in the intervention and sham groups. The researcher will perform all assessments and another person blind to the details of the study will apply both types of stimulation (active/sham). To achieve double-blinding, we will ensure that participants are unaware of the nature of the interventions and the assessor is unaware of participant grouping. To achieve this goal, tDCS interventions will be performed by one person and the baseline treatment and assessment of participants will be performed independently by another person, before and after the intervention. N/A anterior cruciate ligament reconstruction surgery. After conducting the pilot project and determining the number of participants, those who meet the inclusion criteria will be randomly divided into two groups: routine physiotherapy plus anodal-tDCS and routine physiotherapy plus sham-tDCS. A dynamometer will be used to measure the strength of the quadriceps muscle. The dynamometer allowed the research team to measure maximal voluntary isometric contractions before and after the application of tDCS in athletes with anterior cruciate ligament surgery. First, the isometric strength will be evaluated using a dynamometer by collecting the maximum voluntary force of the quadriceps muscles. To assess quadriceps muscle strength, participants will first be asked to perform a 5-minute warm-up exercise on an ergometric bicycle. Then sit on the dynamometer device so that the hip joint is bent at 90 degrees and the knee joint at 90 degrees. Restraint straps will be tightened around the waist and shoulders of each participant to control additional movement during the extension. The tibia, just near the ankle joint, on the anterior surface of the lower limb, 5 cm above the external ankle, is attached with Velcro straps to a pad on the arm of the dynamometer. The participants are told to cross their arms over the chest the entire time during the contractions to avoid unwanted involvement of the upper limbs during the test. Once the participants are properly positioned on the dynamometer, they will perform 2 submaximal voluntary isometric contractions of the knee extensors to familiarize themselves with the methods of assessing muscle strength. These contractions will not be recorded. Then they practice maximal contractions (without electrical stimulation) until the researcher and the subject are sure that the maximal effort is being performed. The participants then perform eight maximal voluntary isometric contractions for the quadriceps femoris in the extension direction with verbal feedback. Through verbal feedback, the patient should be asked to push with maximum effort (with at least 90 seconds of rest between tests). In this research, to perform the CAR test (by FES current), eight times the maximum voluntary isometric contraction of the quadriceps muscle will be performed for six seconds, and after observing and recording a constant value in the amount of torque, electrical stimulation will be applied during the maximum voluntary isometric contraction. This would, in theory, activate the remaining motor units that the patient was unable to perform during their maximal isometric muscle contraction. Electrical stimulation will consist of a group of waves consisting of ten square pulses with a pulse frequency of 100 pps and a pulse deviation of 0.6 milliseconds, with the stimulation intensity set to 2 times the motor threshold of use. The average maximum contractions with and without electric current will be calculated and the amount of voluntary muscle activation will be obtained by the formula. These steps will be done again after 10 sessions of anodal and sham tDCS stimulation.. Yes - There is a plan to make this available What will be shared: In this study, data on quadriceps muscle strength before and after ten sessions of tDCS will be shared after de-identification of subjects When: This data will be available after the completion of the work up to six months after the publication of the results To whom: Researchers working in academic and scientific institutions Conditions: There is nothing wrong with using the data for systematic review Where to obtain: For contact information, please refer to the email address of Naeemeh Haddadi Esfahani at pt_nhaddad@yahoo.com How to obtain: Researchers working in academic and scientific institutions will have access to the data in the shortest possible time by making an official request from their respective faculty and providing documentation from the article in which they intend to use our data Comments:
public Naeemeh Haddadi Esfahani
9th Unit, 4th Floor, Iran Zamin Building, 10th Alley, Mulla Sadra Street, Esfahan
Esfahan Iran (Islamic Republic of) 8168635978 +98 31 3670 2603 pt_nhaddad@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mohsen Rostayi
Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Imam Hossein Square, Damavand Street, Tehran
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1408 roosta@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Athletes who have been at least 4 weeks and at most 3 months since their anterior cruciate ligament surgery 18 years 40 years Male Knee surgery before ACLR Lower extremity injury in the past 6 months other than current ACLR Heart disease, history of stroke, and any problem that has a significant effect on a person's motor function or activity capacity Brain surgery, brain and cranial nerve cancer Migraine Medical records or personal reports of epilepsy or convulsive crises Metal clips inside the skull Cochlear implants or other implanted electronic devices Disturbance of balance or dizziness any active skin infection; or sensitivity to adhesive tape Taking sleeping pills or drugs that alter nerve activity within 48 hours before the evaluation Rehabilitation After conducting the pilot project and determining the number of participants, those who meet the inclusion criteria will be randomly divided into two groups: routine physiotherapy plus anodal-tDCS and routine physiotherapy plus sham-tDCS. A dynamometer will be used to measure the strength of the quadriceps muscle. The dynamometer allowed the research team to measure maximal voluntary isometric contractions before and after the application of tDCS in athletes with anterior cruciate ligament surgery. First, the isometric strength will be evaluated using a dynamometer by collecting the maximum voluntary force of the quadriceps muscles. To assess quadriceps muscle strength, participants will first be asked to perform a 5-minute warm-up exercise on an ergometric bicycle. Then sit on the dynamometer device so that the hip joint is bent at 90 degrees and the knee joint at 90 degrees. Restraint straps will be tightened around the waist and shoulders of each participant to control additional movement during the extension. The tibia, just near the ankle joint, on the anterior surface of the lower limb, 5 cm above the external ankle, is attached with Velcro straps to a pad on the arm of the dynamometer. The participants are told to cross their arms over the chest the entire time during the contractions to avoid unwanted involvement of the upper limbs during the test. Once the participants are properly positioned on the dynamometer, they will perform 2 submaximal voluntary isometric contractions of the knee extensors to familiarize themselves with the methods of assessing muscle strength. These contractions will not be recorded. Then they practice maximal contractions (without electrical stimulation) until the researcher and the subject are sure that the maximal effort is being performed. The participants then perform eight maximal voluntary isometric contractions for the quadriceps femoris in the extension direction with verbal feedback. Through verbal feedback, the patient should be asked to push with maximum effort (with at least 90 seconds of rest between tests). In this research, to perform the CAR test (by FES current), eight times the maximum voluntary isometric contraction of the quadriceps muscle will be performed for six seconds, and after observing and recording a constant value in the amount of torque, electrical stimulation will be applied during the maximum voluntary isometric contraction. This would, in theory, activate the remaining motor units that the patient was unable to perform during their maximal isometric muscle contraction. Electrical stimulation will consist of a group of waves consisting of ten square pulses with a pulse frequency of 100 pps and a pulse deviation of 0.6 milliseconds, with the stimulation intensity set to 2 times the motor threshold of use. The average maximum contractions with and without electric current will be calculated and the amount of voluntary muscle activation will be obtained by the formula. These steps will be done again after 10 sessions of anodal and sham tDCS stimulation. Quadriceps muscle strength. Timepoint: Before application of tDCS current and after ten sessions of application of tDCS current. Method of measurement: Biodex Isokinetic Dynamometer. "Mental preparedness of athletes", "Evaluation of clinical symptoms and performance during sports activities and general performance", "Evaluation of pain and function in daily activities", "Assessment of pain intensity" and "Central activation ratio". Timepoint: Before applying tDCS and after ten sessions of applying tDCS. Method of measurement: ACL-Return to Sport after Injury questionnaire , International Knee Documentation Committee questionnaire , Knee Injury and Osteoarthritis Outcome Score, Visual Analog Scale and Superimpose burst technique for Central Activation Ratio. Shahid Beheshti University of Medical Sciences Approved 2022-10-29 Ethics committee of Shahid Beheshti University of Medical Sciences 9th Unit, 4th Floor, Iran Zamin Building, 10th Alley, Mulla Sadra Street, Esfahan Esfahan Isfehan Iran (Islamic Republic of) Approved 2023-10-29 Ethics committee of Shahid Beheshti University of Medical Sciences 9th Unit, 4th Floor, Iran Zamin Building, 10th Alley, Mulla Sadra Street, Esfahan Esfahan Isfehan Iran (Islamic Republic of)