]>
IRCT20251124068097N1 IRCT 2026-05-28 Shiraz University Neuromodulation Techniques and Improving Balance nGVS The Effects of Pink Noise Induction and Differential Resistance Exercise on Motor Performance Indicators and Balance in Elderly Individuals 2026-02-19 anticipated 48 Recruiting https://irct.ir/trial/87855 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: After baseline assessments and confirmation of eligibility criteria, eligible participants will enter the randomization process. To ensure balanced group sizes and reduce the risk of selection bias, participants will be allocated using a block randomization method. The random allocation sequence will be generated using computer-based randomization software, and variable block sizes (e.g., blocks of 4 and 8) will be used to minimize predictability of group assignment for both researchers and participants. After enrollment, participants will be randomly assigned to one of the following four study groups: Pink Noise Galvanic Vestibular Stimulation group (nGVS only) Differential Resistance Training group (exercise only) Combined Intervention group (nGVS + Differential Resistance Training) Control (Sham) group The random sequence generation and maintenance of allocation codes will be performed by a researcher who is not involved in participant recruitment, outcome assessment, or implementation of the interventions. To ensure allocation concealment, group assignments will be placed in sequentially numbered, opaque, sealed envelopes. After completion of baseline assessments and final enrollment of each participant, the corresponding envelope will be opened by the responsible researcher to determine the assigned study group. All participants will have an equal chance of being allocated to any of the four study groups. In addition, the outcome assessor will remain blinded to participants’ group assignments in order to minimize assessment bias, Blinding description: This study will use a single-blind design. Participants will be blinded to their assigned intervention group, and they will not be informed about the differences between the active and control conditions. In the sham control group, electrodes will be placed on the mastoid processes in the same manner as in the active stimulation group, and the preparation procedures and session duration will be identical to those of the intervention groups, except that no effective electrical current will be delivered. Therefore, participants will not be aware of whether they are receiving active or sham stimulation. Due to the nature of the exercise intervention, the researcher responsible for administering the training sessions and interventions will be aware of group allocation, and complete blinding of the intervention provider is not feasible. However, outcome assessments will be conducted using standardized and identical procedures for all participants in order to minimize assessment bias. In addition, data analysis will be performed using coded group labels to help maintain objectivity during interpretation of the results. N/A Primary Health Condition: Age-related decline in balance and postural control (pre-frailty/frailty associated with aging). Related Terms (for visibility): Fall risk in elderly, Sarcopenia, Sensorimotor decline, Postural sway, Neuromuscular aging. Intervention 1: Intervention group: Pink Noise Galvanic Vestibular Stimulation (nGVS only) Participants receive 30 minutes of subsensory, transcutaneous pink noise electrical stimulation via electrodes on the mastoid processes. Intervention 2: Intervention group: Differential Resistance Training (exercise only). Participants perform 30 minutes of variable medicine ball throwing/catching exercises with constant changes in stance and movement pattern. Intervention 3: Intervention group: Combined Intervention (nGVS + Exercise) Participants simultaneously receive both the 30-minute pink noise nGVS and the 30-minute differential resistance training. Intervention 4: Control group: Sham: Participants undergo an identical 30-minute setup with electrodes placed but receive zero current stimulation and perform no exercise. Yes - There is a plan to make this available What will be shared: All deidentified individual participant data (IPD) collected for the primary and secondary outcomes in this study will be shared. This includes: Baseline demographic data (age group, sex, and fall risk category). Pre- and post-intervention data for: Primary Outcome: RMS of COP in AP axis. Secondary Outcomes: All other COP measures (velocity, sample entropy, Romberg ratio in AP/ML), APA/CPA parameters, maximum elbow torque, and biceps EMG frequency spectrum indices. Group allocation code. When: Availability Start Date: The deidentified IPD and supporting documents will become available 6 months after the publication of the primary results of this trial in a peer-reviewed journal. Availability Period: The data and documents will be made available for a minimum period of 5 years from the start date. To whom: Deidentified IPD and supporting documents will be shared with any qualified researcher worldwide, irrespective of their affiliation (academic, commercial, or non-profit), provided they submit a methodologically sound research proposal for approval. Eligible Recipients: Researchers from academic institutions, healthcare organizations, industry (e.g., medical device or pharmaceutical companies), and independent research consortia. Access Criteria: Requestors must submit a detailed proposal outlining the scientific objective, analysis plan, and ethical considerations to the study's principal investigator or a designated data access committee. Access will be granted for legitimate scientific inquiry aimed at validation, meta-analysis, or novel secondary analysis. Requestors will be required to sign a data use agreement prohibiting attempts to re-identify participants or misuse the data. Conditions: Types of Analyses: Data will be shared for purposes of scientific validation, meta-analysis, or novel secondary research related to aging, sensorimotor function, neurorehabilitation, and balance. Proposals for commercial product development require explicit justification and additional oversight. Review Process: All data access requests will be reviewed by a two-tier committee: Tier 1 (Feasibility & Ethics): The Principal Investigator (PI) and the study's ethics committee representative. Tier 2 (Scientific Merit): An independent panel of two experts in motor control, geriatrics, or biostatistics. Review Criteria: Proposals will be evaluated based on Scientific Rigor: Sound methodology and a clear analysis plan. Ethical Alignment: No intent for re-identification or harmful use. Resource Feasibility: Reasonable scope that can be supported by the provided data. Non-Redundancy: The analysis should not duplicate already published work from the primary team. Access Mechanism: Approved researchers will be granted access via a secure, cloud-based data repository (e.g., Figshare, Zenodo, or a university-managed platform). Data will be provided in standard formats (e.g., .csv, .sav) along with a comprehensive data dictionary and analysis codebook. Agreement: Successful applicants must sign a Data Transfer/Use Agreement (DTUA) legally binding them to the approved use, data security standards, publication ethics (including co-authorship or acknowledgment as per contribution), and destruction of data after the project. Where to obtain: Primary Contact & Communication: All requests for data and documents must be initiated via email to the designated study contact. Contact Person: Ahmadreza Dehghani, Ph.D. in Exercise Physiology Email: adehghani4d@gmail.com/Shiraz University Subject Line: Data Access Request: Pink Noise & Balance Study Secondary Contact (Administrative): For procedural inquiries, a research coordinator can be contacted. Professor Maryam Koushkie Jahromi Email: koushkie53@yahoo.com How to obtain: Access Timeline: Approved applicants can expect to receive the data files approximately 2 weeks after their proposal is formally approved and the signed data use agreement is returned. Comments: Intellectual Property: Researchers using the shared data are encouraged to collaborate with the original study team. Co-authorship on publications will be offered based on substantial intellectual contribution, as per ICMJE guidelines. All publications must acknowledge the original study and funding source. Costs: There is no fee for accessing the data. However, requestors are responsible for any costs associated with data analysis, secure storage, and their own publication fees. Updates: The shared data will be the final, cleaned version used for the primary publication. Corrections or updates will be versioned and noted in the repository. Ethical Re-Use: Any secondary research using this data must obtain its own ethical approval if required by the researcher’s institution or local regulations.
public Ahmadreza Dehghani
بلوار رحمت، بلوار هرمزگان کوچه 18 ساختمان زمرد واحد 1
Shiraz Iran (Islamic Republic of) 7156837144 +98 990 626 7210 adehghani4d@gmail.com Shiraz University scientific Dr. Maryam Koushkie Jahromi
Shiraz university, Eram street, sport science school
Shiraz Iran (Islamic Republic of) 84334-71946 +98 990 626 7210 koushkie53@yahoo.com Shiraz University Iran (Islamic Republic of) Aged 65 years or older Ability to stand independently without assistive devices Ability to follow simple instructions and perform basic movements No diagnosed neurological or musculoskeletal disorders affecting balance. Willing to provide informed consent Resident of Shiraz and accessible for follow-up 60 years 75 years Both History of severe cardiovascular, respiratory, or metabolic diseases Use of medications that significantly affect balance or muscle function Recent history of falls (within the past 6 months) Vestibular disorders or severe visual/hearing impairments Participation in another structured exercise program in the past 3 months Inability to complete the training protocol or attend sessions regularly Treatment - Devices Behavior Treatment - Other Placebo Intervention group: Pink Noise Galvanic Vestibular Stimulation (nGVS only) Participants receive 30 minutes of subsensory, transcutaneous pink noise electrical stimulation via electrodes on the mastoid processes. Intervention group: Differential Resistance Training (exercise only). Participants perform 30 minutes of variable medicine ball throwing/catching exercises with constant changes in stance and movement pattern. Intervention group: Combined Intervention (nGVS + Exercise) Participants simultaneously receive both the 30-minute pink noise nGVS and the 30-minute differential resistance training. Control group: Sham: Participants undergo an identical 30-minute setup with electrodes placed but receive zero current stimulation and perform no exercise. Root Mean Square (RMS) of the Center of Pressure (COP) in the anterior-posterior (AP) axis during quiet standing (eyes open), measured in millimeters (mm). Timepoint: The primary outcome (RMS of COP in the AP axis) will be measured at two time points: Baseline (T0): Immediately before the start of the 30-minute intervention session. Post-Intervention (T1): Immediately after the completion of the same 30-minute intervention session. Method of measurement: The primary outcome variable (RMS of COP in the AP axis) will be measured using a force platform (force plate). Participants will stand quietly on the plate for 30 seconds, and ground reaction force data will be sampled at 1000 Hz. The center of pressure (COP) trajectory will be calculated from this data, and its root mean square (RMS) value in the anterior-posterior direction will be derived using signal processing software (e.g., MATLAB). Secondary Outcome Variables:COP Dynamics: Mean velocity of COP displacement, sample entropy of COP, and Romberg ratio in both anterior-posterior and medial-lateral axes.Postural Control: Duration and amplitude of anticipatory postural adjustments (APA) and amplitude of compensatory postural adjustments (CPA).Neuromuscular Function: Maximum torque of the elbow joint during isokinetic flexion, and the frequency structure (spectral analysis) of biceps brachii EMG activity during elbow flexion. Timepoint: The secondary outcome variables will be measured at the same two time points as the primary outcome:Baseline (T0): Immediately before the start of the 30-minute intervention session.Post-Intervention (T1): Immediately after the completion of the same 30-minute intervention session. Method of measurement: Secondary Outcome Measurement Methods: COP Dynamics (Velocity, Sample Entropy, Romberg Ratio): Measured using the same force platform as the primary outcome, with data processed in MATLAB. Postural Control (APA & CPA): Measured using a force platform synchronized with surface EMG and an accelerometer attached to a pendulum. The EMG onset and amplitude from trunk/leg muscles are analyzed before and after a predictable perturbation (pendulum hit). Neuromuscular Function (Torque & EMG Spectrum): Measured using an isokinetic dynamometer for maximum elbow flexion torque and surface EMG on the biceps brachii muscle. The EMG signal is processed via Fast Fourier Transform (FFT) to analyze its frequency structure. university ( professor's grant) Approved 2025-07-09 ethic committee shiraz university Eram street. Shiraz university shiraz Fars Iran (Islamic Republic of)