EVS With Exercise for Balance With Older Adults

The study will examine whether vestibular stimulation complements exercise-related improvements in balance and physical function. Because both randomized groups participate in the same exercise program, the treatment comparison will estimate the additional effect of active noisy electrical vestibular stimulation (nEVS) relative to sham within that program. Changes across the full exercise program will provide additional context for interpreting the treatment findings.

The randomized trial is embedded within the RISE STRONG program. Participation in the trial will require research consent separate from consent for program services. Individuals who decline or discontinue trial participation may continue to access the exercise program. Exercise participants who are not randomized will not form part of the active-versus-sham comparison.

Randomization and masking Participants will be randomized individually in a 1:1 ratio using a computer-generated sequence with randomly varying block sizes, stratified by the planned stimulation window: exercise weeks 1-6 or 7-12. An independent researcher will generate and securely maintain the allocation sequences. Upcoming assignments will be concealed from recruiting staff, and allocation will be released only after research consent, eligibility confirmation and pretreatment assessments are complete.

Participants and investigators will remain masked to treatment assignment. A separate trained treatment operator may know the assignment to administer the allocated procedure. Access to allocation information will be restricted according to study role. Both groups will use the same equipment setup and scheduled session duration. Participants' perceptions of allocation will be assessed before planned disclosure, as specified in the registered masking outcome.

Integration with the exercise program Exercise will include strength and power, balance, mobility, flexibility and walking activities. Initial exercise placement will reflect baseline physical performance and safety review. Qualified staff will adapt activities and document progression according to each participant's ability and tolerance. Exercise placement and progression will be independent of stimulation assignment.

Each participant will remain in the assigned active or sham group throughout the stimulation course. The early and late stimulation windows are scheduling strata within a parallel-group trial; participants will not cross over between active and sham treatment. Stimulation will be administered seated under supervision, with visits coordinated with exercise attendance where possible.

Assessment timing and consistency Treatment-relative time and exercise-program time will be recorded separately. Treatment week 0 is the pretreatment assessment before the first assigned session. Physical assessments are scheduled at treatment weeks 0, 3 and 6, while the registered patient-reported and cognitive outcomes are assessed before and after the six-week course. The week-6 assessment is the end-of-course endpoint; the week-3 assessment characterizes the interim response.

This schedule will apply to both stimulation windows. For participants treated during exercise weeks 1-6, exercise-program week 12 represents later follow-up after stimulation. For participants treated during exercise weeks 7-12, it coincides with treatment completion. Program-baseline and week-12 observations will therefore be distinguished from treatment-relative observations in the dataset and analyses. Questionnaire and cognitive testing will be scheduled around the assigned stimulation course rather than relying solely on the beginning and end of the exercise program.

Trained assessors will use standardized instructions, sensor placement and scoring procedures across visits. Footwear, walking aids, test setup and assistance will be kept consistent where feasible, and necessary changes will be documented. Rest and close guarding will be provided during physical assessments. Incomplete tests, early termination, use of external support and technical recording failures will be documented separately. Questionnaire assistance will follow the relevant instrument instructions, and administration mode will be recorded.

Safety and treatment delivery Staff will review current symptoms and relevant health changes before study procedures and inspect electrode sites before stimulation. The treatment operator will remain with the participant during each session. Stimulation will be paused for discomfort or dizziness and stopped when indicated; it will not resume while symptoms persist. Physical tasks may be modified or deferred when they cannot be completed safely. Participants will receive study contact information for concerns arising between visits.

Session records will distinguish attendance from completion of the assigned treatment and document interruptions, device problems, modifications and reasons for discontinuation. Adverse events will be monitored throughout the registered surveillance period and reviewed alongside treatment exposure and exercise attendance. Participants who discontinue stimulation may continue outcome assessments if they agree to further research follow-up.

Analysis and data quality The primary analysis will follow the intention-to-treat principle, retaining participants in their randomized groups. End-of-course Phybrata power will be compared using analysis of covariance, adjusting for pretreatment Phybrata power and the assigned stimulation window. Changes from pretreatment will also be summarized. Treatment-effect estimates will be reported with 95% confidence intervals.

Secondary continuous outcomes will be evaluated using appropriate baseline-adjusted models. Repeated physical assessments may additionally be examined using mixed-effects models with participant-level random intercepts and treatment, time and treatment-by-time terms. Categorical and ordinal outcomes will be analyzed using methods appropriate to their measurement scales. Secondary analyses will be interpreted as exploratory, and attendance, treatment completion and safety findings will be summarized descriptively by assigned group. Whole-program changes will be interpreted separately from the randomized treatment comparison.

The statistical analysis plan will specify the balance-condition analysis, processing and trial-aggregation rules, missing-data methods and any sensitivity analyses before comparative treatment results are examined. Missing observations and their reasons will be summarized by group and visit. Data-quality procedures will include checks for completeness and plausible values, documentation of protocol deviations, and version control for processing and analysis.

Research records will use coded study identifiers, with direct identifiers and the linkage key held separately under restricted access. Previously collected program or company-held data will remain distinguishable from prospectively collected trial data and will be used for research only under the applicable consent and ethics permissions. Results will be reported in aggregate, with prespecified and exploratory analyses identified separately.