Randomized ActiveStep Comparative Effectiveness Trial

Falls are the leading cause of fatal and non-fatal injuries in the elderly. Each year an estimated 1/3 of older adults fall, and the likelihood of falling increases substantially with advancing age.2 In 2005, 15,802 elderly patients (> 65 years of age) died as the result of fall-related injuries. According to the 2006 Behavioral Risk Factor Surveillance System (BRFSS) survey, 5.8 million persons aged 65 or older fell at least once during a 3 month period, which represents nearly 16 percent of the elderly population; furthermore, nearly a third of those who fell (1.8 million) sustained some form of injury that resulted in either a doctor's visit or restricted activity for at least 1 day. Falls thus represent a major cause of functional limitation and disability in the elderly. In 2000, the direct medical costs for fall-related injuries was estimated to be $19 billion. Our primary objective is to perform a multi-center, randomized clinical trial to evaluate the comparative effectiveness of a perturbation-based dynamic stability intervention (using the ActiveStep® training system) compared to a traditional physical therapy program in reducing the incidence and severity of falls in a geriatric population.

Modifiable risk factors for falls include muscle weakness, gait and balance problems, poor vision, use of psychoactive medications, and home hazards. Most effective fall-prevention interventions focus on exercise, either alone or as part of a multi-faceted program including medication management, vision correction and home modifications. One Tai Chi based program reduced the risk of falls by 55% in a randomized trial. While exercise programs appear to have efficacy in reducing fall risk, the type, frequency and duration of exercise that is adequate to significantly reduce the risk of falls remain unclear.

External perturbations such as tripping are a major contributor to falls, and trip-related falls account for as many as 20% of all hip fractures.

The ActiveStep® fall prevention training program was developed with NIH funding and consists of a series of increasingly challenging postural disturbances using a microprocessor controlled servo motor that drives a treadmill belt at defined acceleration, velocity, and distance profiles. Initial biomechanical testing of the ActiveStep® training program showed significant improvement in trunk kinematics during a single training session. The ActiveStep® training program is currently available and billable under Medicare reimbursement codes; however, there is a lack clinical data showing that it can reduce falls during patients' routine activities better than standard physical therapy interventions.

The Specific Aims are to: