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.
Comparison of the effect of transcranial direct current stimulation (tDCS) of the motor cortex with routine treatments on quadriceps muscle strength in athletes with ACLR surgery
Design
Double-blind (subject and experimenter) randomized clinical trial
Settings and conduct
Adult male athletes with a history of unilateral ACLR using hamstring autografts were invited to the study through invitations posted in physiotherapy clinics, hospitals in Isfahan. Obtaining entry and exit criteria are selected by non-random and available sampling method. Eligible people enter the study after completing the informed consent form and will be randomly assigned to one of the intervention and sham groups. all the participants complete the personal information questionnaire, KOOS, IKDC, ACL-RSI and VAS questionnaire
The tests are done in the sports science laboratory of Isfahan University and the intervention is done in a private physiotherapy clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Athletes who have been at least 8 weeks and at most 3 months since their surgery
Exclusion criteria:
1. Knee surgery before ACLR
2. Lower extremity injury in the past 6 months other than current ACLR
3. Heart disease, history of stroke
4. Brain surgery, brain cancer and cranial nerves
5. Migraine
6. epilepsy or convulsive crises
7. Metal clips inside the skull
8. Cochlear implants or other implanted electronic devices
9. Impaired balance or dizziness
10. Any active skin infection
11. Taking sleeping pills or drugs that alter nerve activity within 48 hours before the evaluation
Intervention groups
Male athletes 18,40 years old with a history of unilateral ACLR 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.
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Athletes who have been at least 4 weeks and at most 3 months since their anterior cruciate ligament surgery
Exclusion criteria:
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
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
10
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Before application of tDCS current and after ten sessions of application of tDCS current
Method of measurement
Biodex Isokinetic Dynamometer
Secondary outcomes
1
Description
"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
Intervention groups
1
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hasti physiotherapy center
Full name of responsible person
Naeemeh Haddadi Esfahani
Street address
Unit 212, 2nd Floor, Ayrik Building, Noorollahi Alley, North Sheikh Sadouq St, Esfahan
Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Imam Hossein Square, Damavand Street, Tehran
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In this study, data on quadriceps muscle strength before and after ten sessions of tDCS will be shared after de-identification of subjects
When the data will become available and for how long
This data will be available after the completion of the work up to six months after the publication of the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There is nothing wrong with using the data for systematic review
From where data/document is obtainable
For contact information, please refer to the email address of Naeemeh Haddadi Esfahani at pt_nhaddad@yahoo.com
What processes are involved for a request to access data/document
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