This study aimed to evaluate the effects of vestibular rehabilitation training on balance performance and sensory reweighting in older women.
Design
Randomized, parallel-group, single-blind controlled clinical trial with pretest-posttest assessment.
Settings and conduct
The study was conducted at the biomechanics laboratory of Yazd University, Iran. Participants attended baseline and post-intervention assessment sessions. Balance performance was assessed using a force plate under different sensory conditions before and after the 8-week intervention period.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 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; absence of neurological, musculoskeletal, or systemic disorders affecting gait or balance; ability to participate independently in exercise sessions.
Exclusion criteria: regular participation in structured physical activity programs; uncontrolled hypertension; history of severe chest pain, myocardial infarction, or type 1 diabetes; cognitive or psychological disorders affecting functional performance.
Intervention groups
Intervention group: Participants performed supervised vestibular rehabilitation exercises three sessions per week for eight weeks, including eye, head, shoulder, and balance exercises under different sensory conditions.
Control group: Participants continued their usual daily activities and did not receive any structured intervention during the study period.
Main outcome variables
Balance index; sensory system contributions to postural control including visual, vestibular, and proprioceptive dependence
General information
Reason for update
Acronym
VRT-Balance
IRCT registration information
IRCT registration number:IRCT20251115068000N1
Registration date:2026-05-19, 1405/02/29
Registration timing:retrospective
Last update:2026-05-19, 1405/02/29
Update count:0
Registration date
2026-05-19, 1405/02/29
Registrant information
Name
Mostafa Haj Lotfalian
Name of organization / entity
Yazd University
Country
Iran (Islamic Republic of)
Phone
+98 35 3123 3385
Email address
m.hajlotfalian@yazd.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-30, 1403/09/10
Expected recruitment end date
2025-02-28, 1403/12/10
Actual recruitment start date
2024-11-30, 1403/09/10
Actual recruitment end date
2025-02-28, 1403/12/10
Trial completion date
2025-02-28, 1403/12/10
Scientific title
Effects of Vestibular Training on Balance Performance and Sensory Reweighting in Older Women
Public title
Vestibular Training for Balance Improvement in Older Women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 55 years old to 72 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of yazd university
Street address
Safaeia, Daneshgah Blvd
City
یزد
Province
Yazd
Postal code
۸۹۱۵۸۱۸۴۱۱
Approval date
2024-11-27, 1403/09/07
Ethics committee reference number
IR.YAZD.REC.1403.079
Health conditions studied
1
Description of health condition studied
Imbalance
ICD-10 code
R42
ICD-10 code description
Dizziness and giddiness
2
Description of health condition studied
Imbalance
ICD-10 code
R26.89
ICD-10 code description
Other abnormalities of gait and mobility
Primary outcomes
1
Description
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.
2
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Biomechanics Laboratory, Yazd University
Full name of responsible person
Mostafa Haj Lotfalian
Street address
ِDaneshgah Blvd, Biomechanics Laboratory, Faculty of Psychology and Educational Sciences, Yazd University, Yazd, Iran
City
yazd
Province
Yazd
Postal code
۸۹۱۵۸۱۸۴۱۱
Phone
+98 35 3123 3385
Email
M.HAJLOTFALIAN@YAZD.AC.IR
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University
Full name of responsible person
Mohammad Taghi Sadeghi
Street address
Daneshgah Blvd, Yazd University
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۱۸۴۱۱
Phone
+98 35 3123 4444
Email
m.sadeghi@YAZD.AC.IR
Web page address
https://yazd.ac.ir/offices/research/people/head
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University
Full name of responsible person
Mostafa Haj Lotfalian
Position
Assistant porfessor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Biomechanics
Street address
Safaeie, Yazd university
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۱۸۴۱۱
Phone
+98 35 3123 3385
Fax
Email
M.HAJLOTFALIAN@YAZD.AC.IR
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University
Full name of responsible person
Mostafa Haj Lotfalian
Position
Assistant porfessor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Biomechanics
Street address
Safaeie, Yazd university
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۱۸۴۱۱
Phone
+98 35 3123 3385
Fax
Email
M.HAJLOTFALIAN@YAZD.AC.IR
Person responsible for updating data
Contact
Name of organization / entity
Yazd University
Full name of responsible person
Mostafa Haj Lotfalian
Position
Assistant porfessor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Biomechanics
Street address
Safaeie, Yazd university
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۱۸۴۱۱
Phone
+98 35 3123 3385
Fax
Email
M.HAJLOTFALIAN@YAZD.AC.IR
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
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.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Study protocol and statistical analysis plan related to the randomized controlled trial investigating the effects of vestibular rehabilitation training on balance performance and sensory reweighting in older women.
When the data will become available and for how long
The study protocol and statistical analysis plan will be available upon reasonable request after publication of the study results for up to five years.
To whom data/document is available
Researchers and academic investigators with scientific interest in the study topic.
Under which criteria data/document could be used
The documents may be used for academic and scientific purposes only. Requests should include a clear scientific rationale and must comply with ethical and confidentiality regulations.
From where data/document is obtainable
Requests should be directed to the corresponding author via email.
What processes are involved for a request to access data/document
Submitted requests will be reviewed by the research team. If approved, the requested documents will be shared electronically within a reasonable period of time.