Preventing Falls in People Aged 75 or Older at High Risk of Falling Through Specific Rehabilitation Involving Walking Backwards

Justification: Falls are the leading cause of unintentional injuries in the population aged 75 or older in France. Backward walking training has so far been scarcely studied but appears to show promising results compared with conventional rehabilitation across multiple domains. It improves functional capacity, lower limb muscle strength, gait parameters, balance, and stability, all of which are key factors in reducing fall risk. Therefore, we hypothesize that a post-fall rehabilitation program incorporating backward walking sessions may reduce the incidence of falls over one year in high fall risk patients aged 75 or older, compared with a standard rehabilitation program.

Primary objective: The primary objective of the study is to assess the impact of backward walking sessions on the incidence of falls at 1 year in patients aged 75 or older at high risk of falling and managed in a geriatric day hospital, compared with usual care in a geriatric day hospital.

Secondary objectives: The secondary objectives are to assess the effects of backward walking intervention, compared with usual care, on physical and psychological performance as balance, gait speed, functional mobility, fear of falling, and on the occurrence of falls and serious events (time to first fall, all-cause and fall-related hospitalizations, mortality). It also aims to evaluate medium- and long-term quality of life, functional independence, and all-cause hospitalizations, as well as the safety, acceptability, and feasibility of the intervention for patients and the day hospital team.

Settings: The sample size calculation was performed to detect a 35% reduction in the annual incidence rate of falls, assuming a control-group incidence of 1.4-3.6 falls per person-year and accounting for an anticipated 10% loss to follow-up. A total of 300 patients are expected to be enrolled over an 18 month inclusion period, with each patient followed for 12 months. Eleven geriatric centers will participate in the trial.

Experimental design: The PCRetro trial is an open-label, multicenter, randomized controlled, parallel-group clinical trial conducted in a geriatric day hospital rehabilitation setting. The study procedures are as follows: during the geriatric day hospital visit, the investigator will propose participation in the trial to eligible patients after verifying inclusion and exclusion criteria, and will subsequently obtain written informed consent. Patients will then be randomized to the control or intervention arm. Patients in the control arm will undergo two rehabilitation sessions per week for 12 weeks according to usual care. Patients in the intervention arm will undergo two rehabilitation sessions per week for 12 weeks according to usual care, combined with backward walking sessions over 5 weeks. In the intervention arm, backward walking will not increase the overall rehabilitation time but will replace part of usual care in order to achieve two effective 10-minute backward walking sessions per week. Patients will be followed in the same way regardless of their randomization arm, with a medical visit at week 5 and at month 6, and a monthly telephone call by a clinical research assistant blinded to the randomization allocation.