Table 4 Schedule of events
Visit/contact | Baseline | 3 weeks (by phone) | 6 weeks | 3 months | 12 months (by phone) | Comments |
|---|---|---|---|---|---|---|
Target day | 0 | 21 +/−3 | 42 +/−3 | 90 +/−7 | 360 +/−14 | |
Eligibility screening, history | x | |||||
Randomization | x | |||||
VSS-SF | x | x | x | x | x | Primary endpoint, at 6 weeks |
EQ-5D | x | x | x | x | x | |
DHI | x | x | x | |||
T25-FW | x | x | x | |||
Body sway | x | x | x | |||
Enhanced gait and body sway analyses | x | x | x | At selected sites only | ||
vHIT | x | x | x | At selected sites only | ||
Steps, falls, and fractures | x | x | Total steps, since enrollment or last visit | |||
BPPV questions | x | x | ||||
BPPV testing | x | |||||
Compliance | x | x | Questionnaire data, number of weekly sessions | |||
Trial termination form (local) | x | Last site visit, at 3 months | ||||
Trial termination form (central) | x | |||||
Estimated time requirement | 150 min | 15 min | 120 min | 120 min | 15 min | Total 7 h per participant |