Summary
Background
Age-associated
motor and cognitive deficits increase the risk of falls, a major cause
of morbidity and mortality. Because of the significant ramifications of
falls, many interventions have been proposed, but few have aimed to
prevent falls via an integrated approach targeting both motor and
cognitive function. We aimed to test the hypothesis that an intervention
combining treadmill training with non-immersive virtual reality (VR) to
target both cognitive aspects of safe ambulation and mobility would
lead to fewer falls than would treadmill training alone.
Methods
We
carried out this randomised controlled trial at five clinical centres
across five countries (Belgium, Israel, Italy, the Netherlands, and the
UK). Adults aged 60–90 years with a high risk of falls based on a
history of two or more falls in the 6 months before the study and with
varied motor and cognitive deficits were randomly assigned by use of
computer-based allocation to receive 6 weeks of either treadmill
training plus VR or treadmill training alone. Randomisation was
stratified by subgroups of patients (those with a history of idiopathic
falls, those with mild cognitive impairment, and those with Parkinson's
disease) and sex, with stratification per clinical site. Group
allocation was done by a third party not involved in onsite study
procedures. Both groups aimed to train three times per week for 6 weeks,
with each session lasting about 45 min and structured training
progression individualised to the participant's level of performance.
The VR system consisted of a motion-capture camera and a
computer-generated simulation projected on to a large screen, which was
specifically designed to reduce fall risk in older adults by including
real-life challenges such as obstacles, multiple pathways, and
distracters that required continual adjustment of steps. The primary
outcome was the incident rate of falls during the 6 months after the end
of training, which was assessed in a modified intention-to-treat
population. Safety was assessed in all patients who were assigned a
treatment. This study is registered with
ClinicalTrials.gov,
NCT01732653.
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