Addition of a non-immersive virtual reality component to treadmill training to reduce fall risk in older adults (V-TIME): a randomised controlled trial

Overview

Age-related motor and cognitive deficits increase the risk of falls, one of the leading causes of morbidity and mortality. The importance of falls has led to many interventions, but few have aimed to prevent falls by targeting both motor and cognitive functions simultaneously. This Lancet study was designed to test the hypothesis that non-immersive virtual reality (VR) combined with treadmill training would lead to fewer falls than treadmill training alone.

Approaches:

This randomized controlled trial published in the Lancet was conducted at five clinical centers in five countries (Belgium, Israel, Italy, the Netherlands, and the United Kingdom). Using computer-based randomization, individuals aged 60 to 90 years with a history of two or more falls in the past 6 months as well as a variety of motor and cognitive deficits were randomly assigned to receive either treadmill training plus VR or treadmill training alone for 6 weeks.

Stratified randomization was performed by subgroup of patients (those with idiopathic falls, those with mild cognitive impairment, and those with Parkinson’s disease), as well as by sex and clinical site. Third parties were not involved in the onsite study procedures for group allocation. Both groups trained three times a week for six weeks, with each session lasting about 45 minutes and structured training progression tailored to each participant’s performance level. It consisted of a motion-capture camera and a computer-generated simulation projected on a large screen that was designed to reduce fall risk in older adults by including real-life challenges, such as obstacles, multiple pathways, and distractors that needed to continuously be adjusted.

Steps: 

We assessed the incident rate of falls six months after the end of training in a modified intention-to-treat population. The safety of all patients assigned to a treatment was assessed. The study is registered at ClinicalTrials.gov, NCT01732653.

Findings: 

A total of 302 adults were randomly assigned to either the treadmill training plus VR group (n=154) or the treadmill training alone group (n=148) between January 6, 2013, and April 3, 2015. In the prespecified, modified intention-to-treat analysis, 282 (93%) participants were included. The rates of falls before training were similar in both groups (10·7 [SD 35·6] falls per 6 months for treadmill training alone vs 11·9 [39·5] falls per 6 months for treadmill training plus VR). The incident rate decreased significantly in the treadmill training plus VR group after training (6*00 [95% CI 4*36*8*25] falls per 6 months; p*0*0001 vs before training), whereas it did not decrease significantly in the treadmill training alone group (8·27 [5·55−12·31] falls per 6 months; p=0·49). Following the completion of training, the incident rate of falls was also significantly lower in the treadmill training plus VR group than in the treadmill training group (incidence rate ratio 0·58, 95% CI 0·36−0·96; p=0·033). There were no serious training-related adverse events.

Interpretation:

This Lancet study showed that compared to treadmill training alone, treadmill training plus virtual reality reduced fall rates in a diverse group of older adults at high fall risk.