Impact of a two-phase robotic-assisted and home-based training program on falls and fall risk in older adults: a multicenter randomized controlled trial.

BACKGROUND: Falls in older adults represent a significant health risk, and technology-supported interventions have emerged as a potential training solution to reduce fall risk. However, the effectiveness and applicability of such interventions require further evaluation. This study aimed to assess the impact of a novel technology-supported fall prevention program on fall incidence, fall risk, acceptability, and feasibility in community-dwelling older adults. METHODS: In this multicenter randomized controlled trial, 292 older adults (aged ≥ 65 years) were randomly assigned at T0 (baseline) to either an intervention (INT) group or a control (CTR) group. The INT group completed 48 training sessions, commencing with the hunova robot and subsequently engaging in a home-based exercise program. The fall incidence from the initiation of training to the 1-year follow-up (T3) was monitored using fall diaries, while fall risk was evaluated through the administration of the Silver Index with the hunova robot and the timed-up-and-go test (TUG). The acceptability and feasibility of the intervention were evaluated via questionnaires, adherence, and dropout rates. RESULTS: A total of 172 participants finished the study. After completing the intervention period and the 1-year follow-up, the CTR group demonstrated significant increases in both the total number of falls and the number of participants who experienced a fall (PEF) compared to baseline, whereas the INT group showed no significant changes. At follow-up, the incidence rate of falls did not differ significantly between groups, but the risk ratio of PEF was significantly higher in the CTR group after adjusting for baseline values. A significant time × group interaction was observed for the Silver Index, but not for the TUG. Adherence rates were high for both the technology-supported (83.6%) and home-based training (87.7%), with both phases well accepted by the participants. CONCLUSIONS: The two-phase technology-supported intervention demonstrated a potential for reducing falls and PEF, although there was no statistically significant difference between the two groups. The intervention was well received and demonstrated feasibility, indicating the potential for future implementation. Further research is required to investigate the cost-effectiveness of such programs, particularly in populations of older adults at elevated risk of falls. TRIAL REGISTRATION: DRKS00025897. Registered on August 16, 2021.