Outcome Assessment
fracture, fractures, injury or unpleasantness
ADVERSE EVENTS, EVENT
This RCT’s primary outcome was the daily-life fall rates that were collected from fall calendars for the 12 months after the third training session. A fall was defined as “an unexpected event in which the participant comes to rest on the ground, floor, or lower level.”Secondary outcomes included the proportion of participants experiencing at least 1 fall and recurrent falls, time to first fall, fall-related fractures, fall-related injuries, fall-related health care contacts, and daily-life slip and trip falls. A fall-related fracture was a radiologically confirmed fracture from a fall.At the pretraining and posttraining assessments and the 6-month and 12-month follow-up, laboratory falls were evaluated by exposing participants to level-1 slip and trip perturbations. These perturbations were recorded in slow motion (100 fps [frames per second]) with a camera (Canon M200; Canon Inc) that was positioned 2 m away, perpendicular to the center of the treadmill. The video recordings were reviewed by a blinded research assistant to determine whether the participants experienced a fall. An attempt was categorized as a fall when the participant's body posture was in a falling mode that was clearly and unambiguously stopped by the safety harness. The laboratory fall rate (number of laboratory falls per exposed perturbation) was used for analysis. The personnel responsible for the training sessions (J.E.N.) registered all adverse events related to the intervention, including any injury or unpleasantness.