Comparative Effects of the Otago Exercise Program and Virtual Reality Therapy on Static and Dynamic Balance, Gait Speed, and Fall Efficacy in Older Adults: A Randomized Controlled Trial**

compare the effects of the Otago Exercise Program and Virtual Reality Therapy on static and dynamic balance, gait speed, and fall efficacy in older adults

Randomized parallel-group, single-blind (outcome assessor) trial with three groups (Otago, VR, Control) in 66 older adults. Randomization: variable block sizes via Random Allocation Software. Non-pharmacological; measurements at pre-test, post-test, and follow-up.

This study will be conducted at a nursing home in Yasuj. After screening and informed consent, eligible participants are randomly allocated to three groups. Interventions are performed at the center under researcher and physiotherapist supervision. A blinded outcome assessor evaluates all participants at pre-test, post-test, and follow-up.

Participants include older adults aged 65 to 80 years with at least one fall in the past 12 months, ability to walk independently, and a Timed Up-and-Go test score of less than 15 seconds. Exclusion criteria include neurodegenerative diseases, recent stroke, severe visual or hearing impairments, contraindications to physical activity, severe heart disease, uncontrolled diabetes, and use of beta-blockers or antidepressant medications.

Three groups: Otago (12 weeks, three 45-minute sessions per week including strengthening and balance exercises), Virtual Reality (12 weeks, three 40-minute sessions per week using Kinect and balance games), and Control (no intervention, assessed only at designated time points).

Static and dynamic balance (Berg Balance Scale and Timed Up-and-Go test), gait speed (10-meter walk test), and fall efficacy (Falls Efficacy Scale-International) are measured at three time points: pre-test, post-test, and follow-up.

After completion of the screening process and obtaining informed consent, eligible participants will be randomly assigned to three groups (Otago, Virtual Reality, and Control) with a 1:1:1 allocation ratio. The randomization method will be random block design with variable block sizes (4 and 6) to maintain balance in sample size across groups and prevent allocation bias. The unit of randomization is at the individual level. The allocation sequence within blocks will be generated using Random Allocation Software. No stratified randomization will be performed in this study.

In this study, blinding is applied at the level of the outcome assessor. All tests and measurements related to outcome variables (including static and dynamic balance, gait speed, and fall efficacy) will be performed by a trained assessor who is completely blinded to the allocation of study groups (Otago, Virtual Reality, and Control). This assessor has no role in the randomization process, intervention implementation, or participant care, and is solely responsible for collecting pre-test, post-test, and follow-up data. Other groups in this study are not blinded: Participants: are aware of the type of intervention they receive (since Otago exercises and virtual reality are distinguishable). Principal investigator: is aware of group allocation and supervises the proper implementation of interventions. Physiotherapist and clinical caregivers: are aware of the type of intervention each participant receives. Data analyst: is the principal investigator who is aware of group allocation. Data Safety and Monitoring Committee: has not been established for this study (low-risk study with non-pharmacological interventions). Therefore, the only individual who remains blinded in this study is the outcome assessor, who, through allocation concealment and lack of access to the randomization list, prevents bias in data collection.

Individual participant data including demographic information, static and dynamic balance scores (Berg Balance Scale), gait speed (10-Meter Walk Test), and falls efficacy questionnaire scores (FES-I) at three time points (pre-test, post-test, and follow-up). All data will be shared as de-identified Excel files (without personal identifiers such as names, surnames, and national ID codes).

Access to de-identified data will begin 6 months after publication of the main study results and will remain available for up to 5 years thereafter. Upon request by qualified researchers, data will be shared after approval by the ethics committee and in compliance with confidentiality requirements.

Access to data and study documents will be granted exclusively to researchers affiliated with academic institutions and reputable research centers who have an approved research proposal and ethics clearance. Requests from industry or private sector researchers will be reviewed on a case-by-case basis upon submission of a valid research plan and ethics committee approval. All requests must include the purpose of data use, analysis methods, and publication plans. Upon approval by the research team, de-identified data will be shared with the applicant.

Data and study documents may be used exclusively for academic and scientific research purposes, subject to the following conditions: Submission of a valid research proposal with clear objectives and transparent methodology Commitment to use data solely for the stated purposes in the request Commitment to maintain confidentiality and refrain from attempting re-identification of participants Proper citation of the data source in all publications and reports Submission of analysis reports to the primary research team Prohibition of commercial use or financial gain

Applicants wishing to access study data and documents should submit a written request to the Principal Investigator. Contact details are as follows: Principal Investigator: Dr. Ayoub Hashemi (Assistant Professor, Department of Motor Behavior, Yasuj University) Email Address: a.hashemi@yu.ac.ir Phone Number: +98 917 683 5715 Postal Address: Faculty of Literature and Humanities, Department of Sports Sciences, Yasuj University, Postal Code: 7591874934 Application Procedure: Requests must be submitted via email, including a research proposal, purpose of data use, and a confidentiality commitment form. After review by the research team and approval by the ethics committee, de-identified data will be shared with the applicant.

The process for reviewing and responding to requests for study data and documents is as follows: Step 1: Submission of Request The applicant submits a written request along with a research proposal, data use objectives, proposed analysis methods, and a confidentiality commitment form via email to the Principal Investigator. Step 2: Initial Review by Research Team (1 to 2 weeks) The Principal Investigator and research team review the request for scientific merit, ethical compliance, and alignment with study objectives. Additional information may be requested from the applicant during this stage. Step 3: Referral to Ethics Committee (2 to 4 weeks) After initial approval, the request is forwarded to the Ethics Committee for Biomedical Research at the university for final review. The committee verifies the confidentiality commitment and adherence to ethical standards. Step 4: Data Preparation and Provision (1 to 2 weeks) Upon receiving final approval, the research team prepares de-identified data in Excel format or other agreed formats and provides it to the applicant via a secure link or email. Total Estimated Time: Approximately 4 to 8 weeks from the date of submission of a complete and valid request. Note: Incomplete documentation or required revisions may extend this timeframe.

This study is a low-risk, non-pharmacological clinical trial that will be prospectively registered in the Iranian Registry of Clinical Trials (IRCT) before participant enrollment. All procedures will be conducted in accordance with the Declaration of Helsinki and the ethics guidelines of the Ministry of Health. Participant safety is a top priority; all exercise sessions will be supervised by a physiotherapist, and necessary safety equipment will be available. In the event of any adverse event, the intervention will be stopped and appropriate care provided. Participants may withdraw from the study at any time without incurring any costs or limitations, and this will not affect their routine care services. All personal information of participants will remain confidential and will be presented in final reports as aggregated, non-identifiable data.