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IRCT20251115068000N1 IRCT 2026-05-19 Yazd University Vestibular Training for Balance Improvement in Older Women VRT-Balance Effects of Vestibular Training on Balance Performance and Sensory Reweighting in Older Women 2024-11-30 anticipated 30 Complete https://irct.ir/trial/89928 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants were randomly assigned in a 1:1 ratio to either the vestibular rehabilitation training (VRT) group or the control group using a computer-generated randomization sequence created by Random Allocation Software. The sequence was prepared by an independent researcher who was not involved in participant assessment or intervention administration. Allocation concealment was ensured using sealed opaque sequentially numbered envelopes (SNOSE). Each envelope was opened sequentially only after baseline assessment and participant enrollment. The unit of randomization was the individual participant, Blinding description: This study was designed as a single-blind trial in which the outcome assessor was blinded to group allocation. Data analysis was also performed using coded group labels so that the data analyst was unaware of group assignments. Due to the nature of the exercise intervention, blinding of participants and researchers was not feasible. N/A Condition 1: Imbalance. Condition 2: Imbalance. Intervention 1: Intervention group: Vestibular rehabilitation training was performed for 8 weeks, three sessions per week, under the supervision of a physiotherapist. Each session included eye, head, and shoulder movement exercises performed in supine, sitting, and standing positions, along with balance-related activities including sit-to-stand transitions, ball throwing and catching, and walking with eyes closed on flat surfaces and stairs. Each exercise was performed in two 30-second sets with 30 seconds of rest between sets. Exercise intensity was progressively increased throughout the intervention period. Intervention 2: Control group: Participants in the control group did not receive vestibular rehabilitation training or any structured exercise program during the 8-week study period and continued their usual daily activities. Balance and sensory reweighting assessments were performed at the same time points as in the intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is Data related to the study protocol and statistical analysis plan may be available from the corresponding author upon reasonable request after publication of the study results. Individual participant data, informed consent forms, and identifiable information will not be publicly shared to protect participant confidentiality.
public Mostafa Haj Lotfalian
Safaeie, Yazd university
Yazd Iran (Islamic Republic of) ۸۹۱۵۸۱۸۴۱۱ +98 35 3123 3385 M.HAJLOTFALIAN@YAZD.AC.IR Yazd University scientific Mostafa Haj Lotfalian
Safaeie, Yazd university
Yazd Iran (Islamic Republic of) ۸۹۱۵۸۱۸۴۱۱ +98 35 3123 3385 M.HAJLOTFALIAN@YAZD.AC.IR Yazd University Iran (Islamic Republic of) Female participants aged 55 years and older No history of falls or musculoskeletal injury within the previous six months No history of lower-limb surgery No neurological, musculoskeletal, or systemic disorders affecting gait or balance Ability to participate independently in exercise sessions Written informed consent provided 55 years 72 years Female Regular participation in structured physical activity programs (two or more sessions per week) Uncontrolled hypertension (blood pressure >160/100 mmHg) History of severe chest pain, myocardial infarction, or type 1 diabetes Cognitive or psychological disorders affecting functional performance Inability to complete the intervention or assessment sessions R42 R26.89 Dizziness and giddiness Other abnormalities of gait and mobility Rehabilitation Rehabilitation Intervention group: Vestibular rehabilitation training was performed for 8 weeks, three sessions per week, under the supervision of a physiotherapist. Each session included eye, head, and shoulder movement exercises performed in supine, sitting, and standing positions, along with balance-related activities including sit-to-stand transitions, ball throwing and catching, and walking with eyes closed on flat surfaces and stairs. Each exercise was performed in two 30-second sets with 30 seconds of rest between sets. Exercise intensity was progressively increased throughout the intervention period. Control group: Participants in the control group did not receive vestibular rehabilitation training or any structured exercise program during the 8-week study period and continued their usual daily activities. Balance and sensory reweighting assessments were performed at the same time points as in the intervention group. Body sway based on center of pressure displacement during different balance conditions in older women. Timepoint: Measurements were performed at two time points: at baseline (pre-intervention) and after completion of the 8-week vestibular rehabilitation training program (post-intervention). Method of measurement: Balance index was measured using a force plate system by recording center of pressure (COP) displacement in anterior–posterior and mediolateral directions at a sampling frequency of 400 Hz. The standard deviation of COP displacement was calculated as the balance index. Sensory reweighting index based on changes in body sway during different balance conditions in older women. Timepoint: Measurements were performed at two time points: before the intervention (pre-test) and after completion of the 8-week vestibular rehabilitation training program (post-test). Method of measurement: The sensory reweighting index was calculated using force plate data by analyzing changes in center of pressure fluctuations across different balance conditions. The least squares method implemented in MATLAB software was used to estimate the contribution of sensory systems to balance control. Yazd University Approved 2024-11-27 Research Ethics Committees of yazd university Safaeia, Daneshgah Blvd یزد Yazd Iran (Islamic Republic of)