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IRCT20260801070487N1 IRCT 2026-08-08 Tehran University of Medical Sciences The Effect of Practical Training Based on Sensory Evaluation Using Artificial Intelligence on Fear of Falling Among Community-Dwelling Older Adults The Effect of Practical Training Based on Sensory Evaluation Using Artificial Intelligence on Fear of Falling Among Community-Dwelling Older Adults 2026-11-05 anticipated 62 Recruiting https://irct.ir/trial/92174 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method and description: In this study, participants will be allocated to the intervention and control groups using block randomization. The block sizes will include blocks of 4 and 6 participants (including eight blocks of 4 participants and five blocks of 6 participants). Participants will be equally allocated to the intervention group (31 participants) and the control group (31 participants) with an allocation ratio of 1:1. Randomization unit: The unit of randomization in this study is the individual. Each eligible older adult will be independently allocated to one of the two study groups. Randomization strata: Stratified randomization will not be used in this study. Randomization tool: The random allocation sequence will be generated using the online randomization service provided by Sealed Envelope Ltd. Generation of random allocation sequence: The random allocation sequence will be generated using block randomization with block sizes of 4 and 6 participants and an allocation ratio of 1:1 by the online randomization service of Sealed Envelope Ltd. Eligible participants will be assigned to either the intervention or control group according to this sequence. Allocation concealment: Allocation concealment will be performed using opaque and sealed envelopes containing the random allocation sequence (Sequentially Numbered, Opaque, Sealed Envelopes; SNOSE). N/A Fear of falling in older adults. Intervention 1: Intervention group: The intervention will be implemented in two phases. In the first phase, participants will attend two face-to-face sessions at comprehensive health centers in a controlled environment. During these sessions, sensory assessment, including vision and hearing, will be performed in three body positions (standing, sitting, and supine) using an artificial intelligence platform. The platform will assess visual and auditory performance using a digital vision chart and standardized auditory commands. After analyzing the collected data, it will provide targeted feedback, including alerts, notification to the participant and caregiver, and, if necessary, recommendation for specialist evaluation. Participants and their caregivers will also receive training on using the platform, viewing the educational video, responding to platform feedback, and performing practical exercises. The educational content will be tailored according to the initial assessment results and will cover three components: sensory awareness (vision and hearing), environmental and behavioral safety, and cognitive-behavioral training related to fear of falling. At the end of each session, participants' learning will be evaluated using the Teach-Back method, and additional training will be provided if needed. In the second phase, the platform will be installed on the participants' smartphones. Participants will use it at home for eight weeks, three sessions per week, with each session lasting 30–45 minutes, to perform sensory assessment, receive feedback, and complete practical exercises based on the assessment results. During each session, all three body positions will be assessed, and feedback and training will be provided as needed. Throughout the intervention period, the researcher will monitor the correct implementation of the intervention through telephone or video calls, and participants' adherence will be monitored through the platform's automatic data recording system. Intervention 2: Control group: Participants will receive only baseline and post-intervention assessments. During the study, they will not receive any artificial intelligence-based intervention, training, practical exercises, or feedback. 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 The final decision regarding the sharing of de-identified individual participant data has not yet been made. This decision will be determined after completion of the study, taking into account the policies of the university, the ethics committee, the requirements of the target journal, and participants' consent.
public shiva zamani
School of Nursing and Midwifery, Dr. Mirkhani St. (Nosrat-e Sharghi), Towhid Sq., Tehran University of Medical Sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 shiiivazamani@gmail.com Tehran University of Medical Sciences scientific shiva zamani
School of Nursing and Midwifery, Dr. Mirkhani St. (Nosrat-e Sharghi), Towhid Sq., Tehran University of Medical Sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 shiiivazamani@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age 60 years or older Stable general physical condition Ability to move and change body position (sitting, standing, and lying down) without severe medical limitations Ability to walk independently or with an assistive device Correctable vision with eyeglasses or contact lenses (minimum visual acuity required to read the digital Snellen chart) Adequate hearing to understand standard verbal instructions (with or without hearing aids), assessed using a simple word repetition test Ability to communicate Stable psychological and cognitive status with sufficient cognitive ability to understand instructions and respond to the assessments (Mini-Cog score ≥ 3) Ability to read and write at a basic level or availability of a caregiver to assist with understanding the questionnaires and instructions Access to a smartphone and the ability to use it 60 years no limit Both Behavior Behavior Intervention group: The intervention will be implemented in two phases. In the first phase, participants will attend two face-to-face sessions at comprehensive health centers in a controlled environment. During these sessions, sensory assessment, including vision and hearing, will be performed in three body positions (standing, sitting, and supine) using an artificial intelligence platform. The platform will assess visual and auditory performance using a digital vision chart and standardized auditory commands. After analyzing the collected data, it will provide targeted feedback, including alerts, notification to the participant and caregiver, and, if necessary, recommendation for specialist evaluation. Participants and their caregivers will also receive training on using the platform, viewing the educational video, responding to platform feedback, and performing practical exercises. The educational content will be tailored according to the initial assessment results and will cover three components: sensory awareness (vision and hearing), environmental and behavioral safety, and cognitive-behavioral training related to fear of falling. At the end of each session, participants' learning will be evaluated using the Teach-Back method, and additional training will be provided if needed. In the second phase, the platform will be installed on the participants' smartphones. Participants will use it at home for eight weeks, three sessions per week, with each session lasting 30–45 minutes, to perform sensory assessment, receive feedback, and complete practical exercises based on the assessment results. During each session, all three body positions will be assessed, and feedback and training will be provided as needed. Throughout the intervention period, the researcher will monitor the correct implementation of the intervention through telephone or video calls, and participants' adherence will be monitored through the platform's automatic data recording system. Control group: Participants will receive only baseline and post-intervention assessments. During the study, they will not receive any artificial intelligence-based intervention, training, practical exercises, or feedback Fear of falling score based on the total score of the 16-item Falls Efficacy Scale International questionnaire (score range: 16–64). Timepoint: Fear of falling score will be measured using the Falls Efficacy Scale International questionnaire at two time points: at the beginning of the study (baseline) and after completion of the 8-week intervention (post-intervention). Method of measurement: Standard 16-item Falls Efficacy Scale International questionnaire for assessing concerns about the possibility of falling during daily activities. Tehran University of Medical Sciences Approved 2026-04-05 Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o School of Nursing and Midwifery, Dr. Mirkhani St. (Nosrat Sharghi), Towhid Sq., Tehran University of Medical Sciences, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)