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IRCT20221206056727N1 IRCT 2023-02-05 Tabriz University of Medical Sciences The effect of transcranial-Photobiomodulation on balance The effect of transcranial-Photobiomodulation on balance after mental fatigue induction in healthy subjects: a single blind clinical trial 2023-04-02 anticipated 34 Complete https://irct.ir/trial/67963 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We have two envelopes, one of which is written for men and the other for women. Inside each of them are 17 small envelopes, which of them is randomly written with sham or intervention. After entering, each person chooses the envelope related to man or woman, I take one of the small envelopes to determine whether the person will be placed in the sham or intervention group, the participant does not know his group, Blinding description: This study will be done in a blind way. The envelope related to the placement of the person in the sham or intervention group will be opened by the researcher and the participant will not know about his group. N/A Mental fatigue. Intervention 1: Intervention group: For this group, transcranial optical adjustment will be performed in one session. The light will be emitted through the use of a near-infrared light cap with a specific wavelength of 850 nm. The light will be used continuously with a power of 400 milliwatts and an energy density of 24 J/cm. The source of light production in this projector is light emitting diodes, and the desired wavelength, for 3 minutes, bilaterally on the right and left frontal areas (FP1 and FP2), supplementary motor areas (SMA) and primary motor areas. (equivalent to C3 and C4) will be irradiated. The electrodes are placed on a pre-set light cap, which is adjusted according to the electrode placement method of the 10-20 system in EEG. Intervention 2: Control group: The other half of the participants, i.e. the sham group, are falsely exposed to radiation; In this way, radiation is applied to the target area only for 5 seconds per minute. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its release schedule is not yet known.
public Maryam Moghadam Salimi
29 Bahman Ave, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3337 5359 m.salimi.ns@gmail.com Tabriz University of Medical Sciences scientific Maryam Moghadam Salimi
29 Bahman Ave, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3337 5359 m.salimi.ns@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Right-handed people in the age range of 18 to 30 years Body mass index from 19 to 25 Normal vision Normal blood pressure (8-12 mmHg) 18 years 30 years Both History of untreated eye diseases Sleep disorder Pregnancy History of seizures Being left handed Taking medicine or special medicines affecting the nervous system History of neurological-psychological diseases using GHQ (General Health) Questionnaire Neurological or orthopedic disorder of the lower limb Unwillingness to continue attending the study Rehabilitation Rehabilitation Intervention group: For this group, transcranial optical adjustment will be performed in one session. The light will be emitted through the use of a near-infrared light cap with a specific wavelength of 850 nm. The light will be used continuously with a power of 400 milliwatts and an energy density of 24 J/cm. The source of light production in this projector is light emitting diodes, and the desired wavelength, for 3 minutes, bilaterally on the right and left frontal areas (FP1 and FP2), supplementary motor areas (SMA) and primary motor areas. (equivalent to C3 and C4) will be irradiated. The electrodes are placed on a pre-set light cap, which is adjusted according to the electrode placement method of the 10-20 system in EEG. Control group: The other half of the participants, i.e. the sham group, are falsely exposed to radiation; In this way, radiation is applied to the target area only for 5 seconds per minute. Balance. Timepoint: Before mental fatigue - after mental fatigue - after transcranial light therapy. Method of measurement: Forceplate. Attentional performance. Timepoint: Before mental fatigue - after mental fatigue - after transcranial light therapy. Method of measurement: Go/No go cognitive task. Tabriz University of Medical Sciences Approved 2022-11-22 Ethics committee of Tabriz University of Medical Sciences 29 Bahman Ave, Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)