Parallel-design 2-arm pragmatic RCT, with a 3-month intervention and outcomes assessed at 3 and 9 months from baseline.
The lower tertile group included the group of patients with a percentage change decrease at 3 months from baseline.
The higher tertile group included the group of patients with a percentage increase at 3 months from baseline.
The mid tertile group was used as the reference group and represented the group of patients with the least percentage change at 3 months from baseline.
Participants in both cohorts (stroke, control) were followed up for 12 months from baseline, therefore supplying 13 fall diaries.
The second sampling phase included samples from 29/32 subjects who developed active TB 3 47 months from baseline, and 320 age- and sex-matched nonprogressors.
In this study, outcome was recorded 36 months from baseline.
Duration of 24 months from baseline measurement was considered.
Primary endpoint will be 7 months from baseline.
Survivors will be revisited in Stage 2 (18 months from baseline) and Stage 3 (36 months from baseline).
At visit 3 (3 months from baseline) and visit 4 (6 months from baseline), the same procedure as visit 2 was repeated.
