Restorative Environments for Gait Therapy with VR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Forest, Urban, Rural.
- Who it may be relevant to
- Registry conditions: Gait Analysis, Virtual Reality, Attention, Stress. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Restorative Landscape Environments in Virtual Reality (VR) Used in Gait Training to Improve Gait Performance and Affect Restoration in Older Adults with Gait Insecurity - a Pilot Randomized Controlled Trial
Overview
The aim of our study is to investigate the effects of landscapes during gait therapy. The investigators will evaluate the impacts of restorative landscapes as they occur in urban, rural and forest environments. Older people will experience those landscapes using virtual reality (VR) goggles during their gait training. The investigators expect the landscapes to have an effect on the following three aspects: (1) stress reduction, (2) restoration of attention and (3) change in gait parameters. For this purpose, volunteers who are currently inpatient in one of our study centers and already participating in gait therapy will be assigned to a group. The control group will receive the standard therapy. The participants of the intervention groups will receive five additional VR training sessions to the standard therapy. In these sessions, the participants will walk through urban, rural and forest landscapes and perform balance improvement exercises. The five training sessions will take place within ten days. Allocation to the control or intervention groups and their landscapes is random. At the start and end of participation, tests defining stress levels and gait parameters are carried out so that comparisons can be made between before and after treatment. The goal of the study is to find out which type of landscape supports restoration and can therefore contribute to greater gait stability. The investigators expect that improved gait stability will be promoted by stress reduction and increased attention induced by the virtual environments. The investigators are investigating the consequences of repeated application of virtual landscapes and the relationship between the effect of the landscape and the preferences and habits of the study participants.
Detailed description
In this study, the investigators aim to investigate the effectiveness of using restorative landscape environments during gait training to improve walking performance in older people with gait instability. The investigators will examine the effect of different landscape types (urban, rural, forest) on attention restoration and stress recovery based on a study protocol that defines the exact procedures to be used. The landscape scenes shown are prepared to be displayed in any head-mounted display (HMD). Thus, this training is not device specific. As a means to provide training in a virtual landscape the investigators will use as hardware a PC suitable for VR applications and a HTC Vive Pro Eye, which is a commercially available HMD widely used for gaming and for research projects on landscape perception. It can be used with a wireless adapter so that no cable connection between HMD and PC is required, which is more comfortable but not mandatory for conducting this study. This HMD has further the advantage of an included eye-tracker; however, eye-trackers can be adapted to other HMDs as well. The investigators investigate the general effects that virtual landscapes have on stress recovery, attention restoration, and subsequent changes in gait parameters. The results of this study allow us to draw generalizable conclusions about the creation of virtual landscapes that are ideal for supporting gait stability training.
This study examines the effectiveness of training sessions in one of three virtual scenes of different landscape types (urban, rural, and forest) in older adults with instability in gait compared to the usual care for gait instability. Training content and difficulty will be adapted to the individual's physical abilities. Before and after the intervention phase and during the training sessions, various low-risk measurements will be performed, including heart rate variability (HRV), electrodermal activity (EDA), recording of gait parameters, eye-tracking, and standardized interviews to assess recovery and stress management, landscape perception, and balance confidence.
This study contributes to basic research investigating how training in virtual landscapes can promote the improvement of gait stability by contributing to stress reduction as well as recovery of attention, and by providing safe environments for training close to everyday life.
World's population is ageing. This comes along with increasing health-related costs. While it is well known that experiencing landscapes can promote human restoration and foster human health, older people with physical impairments have limited access to landscapes. Therefore, recent research is investigating the benefits of simulated landscapes, in particular with regard to the restorative value of experiencing virtual landscapes. Furthermore, virtual reality (VR) is increasingly implemented in physical rehabilitation to improve walking ability, because it provides new motivating means for performing required exercises in controlled and save environments. Yet, highly immersive high-fidelity VR landscape environments are not employed in such settings although there is great potential to significantly alter the effectiveness of training interventions through their additional restorative effects. Further, it is still unclear which specific landscape elements in an environment foster or hinder the effect of restoration. The influence of the content characteristics of the VR environments needs to be further investigated, linking them to physiological responses, perceptions as well as to meanings and values they have for people.
Therefore, the main goal of the study "REGaitVR RCT" is (1) to investigate the effectiveness of using restorative landscape environments during gait training to improve walking performance in older people with gait instability, and (2) to analyse the effect of the meaning of landscape elements and psychophysiological responses on restoration. To this end, the investigators will examine the effect of different immersive VR landscape types (urban, rural, forest) on attention restoration and stress recovery, and subsequent changes in gait parameters of older people with gait instability in a randomized controlled pilot trial.
Interventions
- Other Forest
Participants in the intervention groups will receive 5 VR training sessions over 10 days in addition to their usual care. Each participant will wear the HMD for 25 minutes in each of this training sessions, whereby he or she will first sit for 5 minutes looking at a forest-landscape. This is followed by 20 minutes of independent exploration of the virtual environment by walking. Depending on the user's gait stability, walking aids (such as walking sticks or rollators) may be used. This phase aim - Other Urban
Participants in the intervention groups will receive 5 VR training sessions over 10 days in addition to their usual care. Each participant will wear the HMD for 25 minutes in each of this training sessions, whereby he or she will first sit for 5 minutes looking at an urban-landscape. This is followed by 20 minutes of independent exploration of the virtual environment by walking. Depending on the user's gait stability, walking aids (such as walking sticks or rollators) may be used. This phase aim - Other Rural
Participants in the intervention groups will receive 5 VR training sessions over 10 days in addition to their usual care. Each participant will wear the HMD for 25 minutes in each of this training sessions, whereby he or she will first sit for 5 minutes looking at a rural-landscape. This is followed by 20 minutes of independent exploration of the virtual environment by walking. Depending on the user's gait stability, walking aids (such as walking sticks or rollators) may be used. This phase aims
Primary outcome measures
- Gait Stability [Time frame: at day 0 and day 11]
Secondary outcome measures (12)
- Variability (Gait Parameter) [Time frame: day 0 - 11]
- Speed (Gait Parameter) [Time frame: day 0 - 11]
- Asymmetry (Gait Parameter) [Time frame: day 0 - 11]
- Stance (Gait Parameter) [Time frame: day 0 - 11]
- Max. Heel Clearance (Gait Parameter) [Time frame: day 0 - 11]
- 1-Minute-Sit-to-Stand Test (1-Min-STST) [Time frame: at day 0 and day 11]
- Perceived Restorativeness Scale (PRS) (Attention Restoration) [Time frame: day 0 - 11]
- Perceived Stress Scale (PSS) (Stress Reduction) [Time frame: day 0 - 11]
- Skin Conductance Levels (SCL) (Stress Reduction) [Time frame: day 0 - 11]
- Non-Specific Skin Conductance Responses (NS-SCRs) (Stress Reduction) [Time frame: day 0 - 11]
- Event-related Skin Conductance Responses (ER-SCRs) (Stress Reduction) [Time frame: day 0 - 11]
- Standard deviation of all NN (normal-to-normal) intervals (SDNN) (Heart Rate Variability (HRV), Stress Reduction) [Time frame: day 0 - 11]
Eligibility criteria
Inclusion criteria
- age: > 65 years
- german-speaking
- ability to give informed consent
- attends gait safety training (usual care)
- inpatient for a duration of min. 2 weeks in one of the study sites
- items 7 - 15 of the De Morton Mobility Index (DEMMI): min. 2 points, max. 9 points
- 3-minute walking distance: > 30 m without rest, with or without walking aids, overground walking on flat surface
Exclusion criteria
- epilepsy
- Partial weight bearing or conservatively or surgically treated billing with weight bearing as determined by symptoms
- Severe hearing impairment (if not corrected with hearing aid)
- Injuries to the eyes, face, or neck that prevent comfortable use of VR glasses.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 3 centers
- Spitäler Schaffhausen — Schaffhausen
- Geriatrische Klinik St. Gallen — Sankt Gallen
- Spital Zollikerberg — Zollikerberg
Identifiers
NCT: NCT06304077 · 2023-01894 · 000005739