Elsevier

The Lancet

Volume 388, Issue 10050, 17–23 September 2016, Pages 1170-1182
The Lancet

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

https://doi.org/10.1016/S0140-6736(16)31325-3Get rights and content

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.

Findings

Between Jan 6, 2013, and April 3, 2015, 302 adults were randomly assigned to either the treadmill training plus VR group (n=154) or treadmill training alone group (n=148). Data from 282 (93%) participants were included in the prespecified, modified intention-to-treat analysis. Before training, the incident rate of falls was 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). In the 6 months after training, the incident rate was significantly lower in the treadmill training plus VR group than it had been before training (6·00 [95% CI 4·36–8·25] falls per 6 months; p<0·0001 vs before training), whereas the incident rate did not decrease significantly in the treadmill training alone group (8·27 [5·55–12·31] falls per 6 months; p=0·49). 6 months after the end of training, the incident rate of falls was also significantly lower in the treadmill training plus VR group than in the treadmill training group (incident rate ratio 0·58, 95% CI 0·36–0·96; p=0·033). No serious training-related adverse events occurred.

Interpretation

In a diverse group of older adults at high risk for falls, treadmill training plus VR led to reduced fall rates compared with treadmill training alone.

Funding

European Commission.

Introduction

Gait impairments and falls are ubiquitous among older adults (roughly >65 years) and patients with many neurological diseases. About 30% of community-dwelling adults older than 65 years fall at least once per year.1 Among people with mild cognitive impairment, dementia, or Parkinson's disease, falls are even more common with 60–80% of individuals reporting falls each year.2 The consequences of falls often are severe, leading to loss of functional independence, social isolation, institutionalisation, disability, and death.1 Falls also place a huge burden on health-care systems, accounting for 1–2% of all health-care expenditures in many high-income countries.3

Most falls occur during walking4 and hence gait impairment is associated with an increased fall risk.5 Falls in elderly people often occur as a result of tripping and poor obstacle negotiation,6 with the lower leg of older adults passing dangerously close to impediments during walking.7 Obstacle negotiation also relies on cognitive resources, including motor planning, divided attention, executive control, and judgment,8 partly explaining why age-related decline in cognitive function is associated with increased fall risk.9

Research in context

Evidence before this study

We searched PubMed and the Cochrane Database for relevant articles published from Jan 1, 1980, to Dec 31, 2015. We used the keywords “falls”, “prevention training”, “aging”, “older adults”, and “Parkinson's disease”. We found several reviews and meta-analyses. Many intervention programmes based on reported multiple risk factors have been proposed and assessed. However, despite extensive knowledge about fall risk, no consensus exists as to the most effective or optimum treatment approach. To date, the effect of common treatment approaches on fall risk tends to be small and the reported changes are mainly focused on motor aspects with limited long-term retention. Furthermore, most trials have compared a fall prevention intervention with no intervention or an intervention not expected to reduce falls, showing the need for studies with an active control comparison. A paucity of studies targeting participants with cognitive deficits was also noted. Additionally, recent work on the role of the central nervous system in mobility calls for multimodal interventions that target multiple pathways simultaneously, using an adaptive and individually tailored treatment in an enjoyable and challenging environment to increase adherence and maintenance.

Added value of this study

To our knowledge, this study describes the largest randomised controlled trial to investigate use of a multimodal, motor-cognitive training approach with a virtual reality component for the reduction of falls in older adults. Advantages of this approach include the fact that it provides training in a more engaging, stimulating, and enriched environment than does traditional rehabilitation, gives feedback about performance to the participant to enable the learning of new motor strategies of movement, and simultaneously addresses motor and cognitive aspects of fall risk that are crucial to safe ambulation. We compared our multimodal approach with an active comparison intervention (a matched treadmill training programme) but without the virtual reality component, to better estimate the added effect of the virtual reality system. Our results showed that treadmill training alone and treadmill training with virtual reality both reduced the risk of falls. Furthermore, the approach with a virtual reality component reduced fall rate and fall risk to a greater degree than did the active control comparison group.

Implications of all available evidence

Falls are widespread and common among older adults. However, ample evidence suggests that fall rates and risk can be reduced, even among older adults with an especially high risk of falls, such as people with Parkinson's disease. Multimodal approaches that target motor and cognitive function might have added value on top of that from an intervention that focuses on motor control alone. Our results suggest that interventions that combine technology, mobility training, and cognitive remediation to reduce the risk of falls and enhance mobility can reduce fall rates and fall risk among the elderly, even among those with chronic disease and cognitive deficits. Targeting of both the cognitive aspects of safe ambulation and mobility aspects through treadmill training is feasible, with little added cost compared with treadmill training alone, and with high levels of compliance, even in patients with neurodegenerative diseases and other high-risk populations. A game-like approach based on virtual reality seems to be able to engage subjects, motivate compliance, and reduce fall rates.

Various intervention programmes have aimed to reduce fall risk.10 However, despite the increasing recognition of the importance of cognition, motor, and obstacle negotiation abilities, previous multifactorial interventions have generally focused on individual risk factors separately, largely ignoring their interdependence. Cognition and motor aspects might both be targeted, but usually only individually. Growing evidence11, 12, 13 and the increasing recognition of the importance of cognition for safe walking14, 15 suggest that a multimodal treadmill training programme augmented with a computer-simulated non-immersive virtual reality (VR) could improve both motor and cognitive aspects of fall risk.16 Generally, VR is defined as a high-end-computer interface that involves real-time simulation and interactions through multiple sensorial channels.16, 17 Such an approach can be used to provide training in a stimulating and enriching environment that targets both motor and cognitive function, while also providing feedback about performance to assist with learning new motor strategies of movement. Integrated approaches that concurrently target motor and cognitive contributors to safe ambulation have not been well studied. Consistent with existing recommendations,10, 18 we postulated that simultaneously training the motor and cognitive aspects of falls would help to reduce fall rates and ameliorate fall risk.

We aimed to test the hypothesis that a 6 week programme of treadmill training combined with a VR component would lead to a lower incidence of falls than would a similar intensity intervention delivered via treadmill training alone. We investigated this hypothesis in older adults at high risk of future falls based on a recent history of multiple falls, including people who had idiopathic falls, individuals with mild cognitive impairment, and people with Parkinson's disease.

Section snippets

Study design and participants

We conducted a prospective, single-blind, randomised controlled trial, with 6 months follow-up, at five clinical centres across five countries (Belgium, Israel, Italy, the Netherlands, and the UK; appendix). The trial was approved by the medical ethics review committee at each site. Details of the protocol and study design have been reported previously16 and additional details are available online.

We recruited community-living older adults via flyers, advertising, presentations at local

Results

661 individuals were screened. The most common reason for ineligibility was fewer than two falls in the 6 months before the study. Between Jan 6, 2013, and April 3, 2015, 302 participants were recruited who met the inclusion criteria, consented to participate, and were then randomly assigned to one of the training groups (148 to treadmill training alone and 154 to treadmill training plus VR). 16 (5%) participants dropped out before starting training, and four (1%) participants did not complete

Discussion

To our knowledge, this study is the first to investigate the effects of an intensive treadmill-based intervention with and without a VR component on fall rates in an older adult population with a high risk of falls. Both treadmill training interventions significantly improved markers of fall risk and fall rates were lowered for both interventions compared with values from before training, emphasising the therapeutic value of the active control intervention (ie, treadmill training alone).

References (43)

  • BH Wood et al.

    Incidence and prediction of falls in Parkinson's disease: a prospective multidisciplinary study

    J Neurol Neurosurg Psychiatry

    (2002)
  • S Heinrich et al.

    Cost of falls in old age: a systematic review

    Osteoporos Int

    (2010)
  • A Ashburn et al.

    The circumstances of falls among people with Parkinson's disease and the use of falls diaries to facilitate reporting

    Disabil Rehabil

    (2008)
  • MB van Iersel et al.

    Executive functions are associated with gait and balance in community-living elderly people

    J Gerontol A Biol Sci Med Sci

    (2008)
  • AL Rosso et al.

    Aging, the central nervous system, and mobility

    J Gerontol A Biol Sci Med Sci

    (2013)
  • Summary of the updated American Geriatrics Society/British Geriatrics Society clinical practice guideline for prevention of falls in older persons

    J Am Geriatr Soc

    (2011)
  • A Mirelman et al.

    Virtual reality for gait training: can it induce motor learning to enhance complex walking and reduce fall risk in patients with parkinson's disease?

    J Gerontol A Biol Sci Med Sci

    (2011)
  • P Eggenberger et al.

    Multicomponent physical exercise with simultaneous cognitive training to enhance dual-task walking of older adults: a secondary analysis of a 6-month randomized controlled trial with 1-year follow-up

    Clin Interv Aging

    (2015)
  • M Montero-Odasso et al.

    Gait and cognition: a complementary approach to understanding brain function and the risk of falling

    J Am Geriatr Soc

    (2012)
  • M Yamada et al.

    Complex obstacle negotiation exercise can prevent falls in community-dwelling elderly Japanese aged 75 years and older

    Geriatr Gerontol Int

    (2012)
  • A Mirelman et al.

    V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial

    BMC Neurol

    (2013)
  • Cited by (0)

    View full text