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IRCT20151228025732N85 IRCT 2026-08-16 Semnan University of Medical Sciences Evaluating the Effectiveness of Cognitive Behavioral Therapy Combined with Transcranial Direct Current Stimulation over dorsolateral prefrontal cortex on Fear of Falling and Social Frailty in Older Adults with Fear of Falling Evaluating the Effectiveness of Cognitive Behavioral Therapy Combined with Transcranial Direct Current Stimulation over dorsolateral prefrontal cortex on Fear of Falling and Social Frailty in Older Adults with Fear of Falling 2026-08-06 anticipated 30 Complete https://irct.ir/trial/91779 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization; Individual; Random Number Tables. Randomized permutation blocks (block 2). It will be done based on computer assisted coding, Blinding description: Blinding of the analyst, the outcome evaluator and the participant (double-blind) is done so that the groups are defined as A and B for the patients and provided to the analyst and the outcome evaluator so they do not know about the grouping method. N/A Fear of falling. Intervention 1: Intervention group: In this group, according to the protocol, patients receive cognitive-behavioral therapy (CBT) exercises along with transcranial direct current stimulation (tDCS) with an intensity of approximately 2 mA for 20 minutes on the dorsolateral prefrontal cortex (DLPFC) for 4 weeks, 2 sessions per week. Intervention 2: Control group: In this group, according to the protocol, patients receive cognitive-behavioral therapy (CBT) exercises along with unreal transcranial direct current stimulation (tDCS) for 4 weeks, 2 sessions per week. This is for comparison with the intervention group only. 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 No more information.
public Fatemeh Ehsani
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4180 are20935@gmail.com Semnan University of Medical Sciences scientific Semnan University of Medical Sciences
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4180 are20935@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Age 60 to 75 years Living in Semnan city Having a fear of falling in the past year Absence of severe neurological or psychiatric conditions that would prevent participation in the intervention (such as advanced dementia or severe movement disorders) Adequate cognitive ability to answer questionnaires 60 years 75 years Both Absence from more than one meeting Having acute or chronic illnesses (such as epilepsy, metal implants in the head, or uncontrolled cardiovascular disease) Taking medications that negatively affect cognitive function or balance (psychotropic drugs and opioid analgesics) A history of recent surgery or injury that affects balance F40.233 Fear of injury Rehabilitation Diagnosis Intervention group: In this group, according to the protocol, patients receive cognitive-behavioral therapy (CBT) exercises along with transcranial direct current stimulation (tDCS) with an intensity of approximately 2 mA for 20 minutes on the dorsolateral prefrontal cortex (DLPFC) for 4 weeks, 2 sessions per week. Control group: In this group, according to the protocol, patients receive cognitive-behavioral therapy (CBT) exercises along with unreal transcranial direct current stimulation (tDCS) for 4 weeks, 2 sessions per week. This is for comparison with the intervention group only. Fear of falling. Timepoint: Before the intervention, immediately after the intervention, and one month after the intervention. Method of measurement: Using the Functional Efficacy in the Elderly Questionnaire (FES-I). The level of social vulnerability of the elderly. Timepoint: Before the intervention, immediately after the intervention, and one month after the intervention. Method of measurement: Using the Social Frailty Questionnaire (SFS-8). Functional balance. Timepoint: Before the intervention, immediately after the intervention, and one month after the intervention. Method of measurement: Berg Balance Scale (BBS). Semnan University of Medical Sciences Approved 2026-06-22 Ethics committee of Semnan University of Medical Sciences Semnan University of Medical Sciences, Basij Blvd, Semnan Semnan Semnan Iran (Islamic Republic of)