Clinical trial NCT06304077: Restorative Environments for Gait Therapy with VR
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gait Analysis
Virtual Reality
Attention
Stress
Keywords: virtual reality (VR) based gait therapy
Lead sponsor: ETH Zurich
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 84
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, multi-arm (4-arm), open-label pilot controlled trial with an allocation ratio of 1:1:1:1 (per intervention group (urban, rural, forest) : control). The study setup is multicentric (Geriatrische Klinik St. Gallen, Spitäler Schaffhausen, Spital Zollikerberg).
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Gait Stability
timeFrame: at day 0 and day 11
Secondary outcomes:
measure: Variability (Gait Parameter)
timeFrame: day 0 - 11
measure: Speed (Gait Parameter)
timeFrame: day 0 - 11
measure: Asymmetry (Gait Parameter)
timeFrame: day 0 - 11
measure: Stance (Gait Parameter)
timeFrame: day 0 - 11
measure: Max. Heel Clearance (Gait Parameter)
timeFrame: day 0 - 11
measure: 1-Minute-Sit-to-Stand Test (1-Min-STST)
timeFrame: at day 0 and day 11
measure: Perceived Restorativeness Scale (PRS) (Attention Restoration)
timeFrame: day 0 - 11
measure: Perceived Stress Scale (PSS) (Stress Reduction)
timeFrame: day 0 - 11
measure: Skin Conductance Levels (SCL) (Stress Reduction)
timeFrame: day 0 - 11
measure: Non-Specific Skin Conductance Responses (NS-SCRs) (Stress Reduction)
timeFrame: day 0 - 11
measure: Event-related Skin Conductance Responses (ER-SCRs) (Stress Reduction)
timeFrame: day 0 - 11
measure: Standard deviation of all NN (normal-to-normal) intervals (SDNN) (Heart Rate Variability (HRV), Stress Reduction)
timeFrame: day 0 - 11
measure: Root Mean Square of Successive Differences (RMSSD) (Heart Rate Variability (HRV), Stress Reduction)
timeFrame: day 0 - 11
measure: LF/HF-ratio (Heart Rate Variability (HRV), Stress Reduction)
timeFrame: day 0 - 11
measure: Heart Rate change (ΔHR) (Meaning / Valence of Landscapes)
timeFrame: day 1 - 10
measure: Questionnaire / structured interview on landscape preferences and meanings ascribed to landscapes (Meaning / Valence of Landscapes)
timeFrame: day 0
measure: Gaze patterns
timeFrame: day 1 - 10
Other outcomes:
measure: Age (Demographic data)
timeFrame: day 0
measure: Height (Demographic data)
timeFrame: day 0
measure: Weight (Demographic data)
timeFrame: day 0
measure: Gender (Demographic data)
timeFrame: day 0
measure: Education (Demographic data)
timeFrame: day 0
measure: Diagnosis and reason for gait stability training
timeFrame: day 0
measure: Time since last fall
timeFrame: day 0
Locations:
city: Zollikerberg
country: Switzerland
facility: Spital Zollikerberg
state: Zürich
city: Schaffhausen
country: Switzerland
facility: Spitäler Schaffhausen
city: St. Gallen
country: Switzerland
facility: Geriatrische Klinik St. Gallen
Study officials:
affiliation: ETH Zürich
name: Ulrike Wissen Hayek, Dr.
role: PRINCIPAL_INVESTIGATOR
References: