Gait AnalysisREGaitVRNCT06304077
Restorative Environments for Gait Therapy with VR
A study testing Forest, Urban and Rural in people with Gait Analysis and Virtual Reality, run by ETH Zurich at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Gait Analysis, Virtual Reality, Attention
- What is being tested?
- Forest, Urban and Rural
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 23 Apr 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites, 3 recruiting
- Not yet recruiting
Geriatrische Klinik St. Gallen
Sankt Gallen, Canton of St. Gallen, 9000
Dzuza Papik, +41 (0)71 243 88 30, dzuza.papik@geriatrie-sg.ch
- Not yet recruiting
Spitäler Schaffhausen
Schaffhausen, Canton of Schaffhausen, 8208
Eliane Hepfer, +41 (0)52 634 83 50, eliane.hepfer@spitaeler-sh.ch
- Recruiting
Spital Zollikerberg
Zollikerberg, Canton of Zurich, 8125
Cor Dekker, +41 (0)44 397 27 11, cor.dekker@therapien-zollikerberg.ch
About this study
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
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.
Read the 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.
- Conditions
- Gait Analysis, Virtual Reality, Attention, Stress
- Being tested
- Forest, Urban, Rural
- Keywords
- virtual reality (VR) based gait therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForestOther
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 aims at keeping the participant walking.
UrbanOther
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 aims at keeping the participant walking.
RuralOther
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 at keeping the participant walking.
| Study group | Role | What they receive |
|---|---|---|
| forest | Experimental | virtual reality (VR) assisted gait therapy in a forest landscape Receives: Other: Forest |
| urban | Experimental | virtual reality (VR) assisted gait therapy in a urban landscape Receives: Other: Urban |
| rural | Experimental | virtual reality (VR) assisted gait therapy in a rural landscape Receives: Other: Rural |
| control | No intervention | standard gait therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Stability
The German version of the Activities-specific Balance Confidence (ABC) Scale is used to assess balance self-confidence in older people. Self-report of fear of falling correlates with performance on the blindfolded and one-legged tests, and in addition, fear of falling can lead to activity limitation, resulting in a decline in physical performance. It has a 11-point response scale (no confidence 0% - 100% completely confident) and the overall score it calculated by summing the scores and dividing by the number of items (16). Cut-off scores are < 50% (lower level of physical functioning), 50-80% (moderate level) and > 80% (high level), a score smaller than 67% indicated a risk for falling. The ABC scale can be complected within 5-10 minutes.It could show an internal consistency of the ABC scale of 0.94 and a test-retest reliability of 0.85 (95% CI, 0.68, 0.93).
Measured: at day 0 and day 11
Secondary outcomes (17)
Variability (Gait Parameter)
[%] Defined as the coefficient of variation in cycle time, greater variability in step time may be a predictor of future falls. Fallers have significantly greater gait variability than non-fallers, who have comparable results to young subjects.
Measured: day 0 - 11
Speed (Gait Parameter)
[m/s] Fallers have a slower mean forward walking speed. Older people with slow walking speeds (≤ 1.3 m/s) are almost 8 times more likely to fall.
Measured: day 0 - 11
Asymmetry (Gait Parameter)
[%] Gait asymmetry increases with age and has been identified as a factor associated with falls in older adults. It is greater in people at risk of falling than in those who do not fall. Asymmetry is inversely correlated with preferred walking speed, and asymmetric gait is positively correlated with fall risk and dependence in activities of daily living.
Measured: day 0 - 11
Stance (Gait Parameter)
[%] The greater the variability in the proportion of the cycle in which the foot touches the ground, the greater the change for future mobility disability.
Measured: day 0 - 11
Max. Heel Clearance (Gait Parameter)
[m] The height of the foot during the swing phase appears to be an important gait parameter related to the risk of falling, as insufficient clearance can directly lead to stumbling, which is a major cause of falls in the elderly. Clearance parameters are a significant predictor of falls.
Measured: day 0 - 11
1-Minute-Sit-to-Stand Test (1-Min-STST)
It is a measure for mobility related functions and physical performance often used to access older people. It is a simple and quick exercise to assess the functional status of a patient and the gesture of getting up is an essential everyday activity. The test will be conducted according to the protocol of Hollier (2022, https://www.pcrs-uk.org/sites/default/files/2022-December-PCRU-1-MSTST.pdf). Reference Values of the sit-to-stand test given by Strassmann et al. 2013 (DOI: 10.1007/s00038-013-0504-z)
Measured: at day 0 and day 11
Perceived Restorativeness Scale (PRS) (Attention Restoration)
The operationalization of the Attention Restoration Theory (ART) can be found in the Perceived Restorativeness Scale (PRS) from Hartig et al. (1996). This scale is a valid and reliable measure of quality in restoration in different environments and has proved the sensitivity to theoretically relevant differences between environments. This self-report measurement is used in the majority of studies where researchers wanted to quantify restoration of environment. Answers can be given from 0 (not true at all) to 10 (Completely true).The scale has 26 items which can be divided into 7 categories: being away (max. point: 30), coherence (max. point: 24), compatibility (max. point: 30), fascination (max. point: 36), familiarity (max. point: 6), preference (max. point: 12), scope (may. point: 18). The investigators will use the German translation from Cervinka et al. (2016).
Measured: day 0 - 11
Perceived Stress Scale (PSS) (Stress Reduction)
To measure the stress level of patients in hospital the investigators will use the self-reported Perceived Stress Scale (PSS) which is the most widely used scale for measuring the perception of stress of an individual. The 10-item scale is easy to understand and the scoring is from 1 (Never) to 5 (Very Often). We will use the German version of the PSS-10 translated and verified by Schneider et al. (2020). A score from 10 to 50 can be reached.
- Scores ranging from 10-23 would be considered low stress.
- Scores ranging from 24-36 would be considered moderate stress.
- Scores ranging from 37-50 would be considered high perceived stress
EDA can be measured with only two electrodes on the skin surface. The investigators will use the Empatica E4 wristband for the measurement.
Measured: day 0 - 11
Skin Conductance Levels (SCL) (Stress Reduction)
As a non-invasive method, Electrodermal Activity (EDA) measurements is used widely for detecting stress and emotions [101] as it is controlled by the autonomic nervous system. It's a real-time measurement, related to the level of physiological arousal. It is a widely used method in attention restoration studies (VR and real). The two components, tonic and phasic, can be used to analyse two different characteristics. The tonic, also called skin conductance level (SCL), is related to the slow-changing signals.
Stress Recovery can be shown by an lower level of skin conductance fluctuations.
EDA can be measured with only two electrodes on the skin surface. The investigators will use the Empatica E4 wristband for the measurement.
Measured: day 0 - 11
Non-Specific Skin Conductance Responses (NS-SCRs) (Stress Reduction)
As a non-invasive method, Electrodermal Activity (EDA) measurements is used widely for detecting stress and emotions as it is controlled by the autonomic nervous system. It's a real-time measurement, related to the level of physiological arousal. It is a widely used method in attention restoration studies (VR and real). The two components, tonic and phasic, can be used to analyse two different characteristics. the phasic component, also called skin conductance response (SCR), can be associated with a stimulus.
NS-SCRs is used for epoch-based studies and can indicate an overall arousal; there usually expressed as average of intervals with responses per unit of time; The mean amplitude of NS-SCR can indicate a change in the level of stress. During rest we have 1-3 NS-SCRs/min, whereas we can have over 20 NS-SCRs/min in high arousal situations.
EDA can be measured with only two electrodes on the skin surface. The investigators will use the Empatica E4 wristband for the measurement.
Measured: day 0 - 11
Event-related Skin Conductance Responses (ER-SCRs) (Stress Reduction)
For quantifying the response to a given stimulus (used in stimulus-driven studies).
EDA can be measured with only two electrodes on the skin surface. The investigators will use the Empatica E4 wristband for the measurement.
Measured: day 0 - 11
Standard deviation of all NN (normal-to-normal) intervals (SDNN) (Heart Rate Variability (HRV), Stress Reduction)
The fluctuation of the length of heart beat intervals, also called Heart Rate Variability (HRV) represents the ability of the heart to respond to stimuli (physiological and environmental). Several studies have shown, that HRV is a good indicator of stress as well as perceived valence (i.e., like or dislike) of image content. The measurement is non-invasive and can be done with the Empatica E4 wristband as well.
SDNN is the index of physiological resilience against stress
Measured: day 0 - 11
Root Mean Square of Successive Differences (RMSSD) (Heart Rate Variability (HRV), Stress Reduction)
The fluctuation of the length of heart beat intervals, also called Heart Rate Variability (HRV) represents the ability of the heart to respond to stimuli (physiological and environmental). Several studies have shown, that HRV is a good indicator of stress as well as perceived valence (i.e., like or dislike) of image content. The measurement is non-invasive and can be done with the Empatica E4 wristband as well.
RMSSD is known as the value for the body's ability to recover, the greater this number, the better.
Measured: day 0 - 11
LF/HF-ratio (Heart Rate Variability (HRV), Stress Reduction)
The fluctuation of the length of heart beat intervals, also called Heart Rate Variability (HRV) represents the ability of the heart to respond to stimuli (physiological and environmental). Several studies have shown, that HRV is a good indicator of stress as well as perceived valence (i.e., like or dislike) of image content. The measurement is non-invasive and can be done with the Empatica E4 wristband as well.
The ratio of the power in low frequency range (0.04Hz and 0.15Hz) to the power in high frequency range (0.15Hz and 0.4Hz) can indicate changes in stress levels
Measured: day 0 - 11
Heart Rate change (ΔHR) (Meaning / Valence of Landscapes)
In addition, HRV is an indicator of perceived valence (i.e., like or dislike) of image content.
Pre- and post-stimulus Inter-Beat Intervals (IBIs) are combined to construct a heart rate change time course with respect to the mean pre-stimulus heart rate (= baseline value). Immediate, dramatic deceleration in heart rate has been associated with negatively valent stimuli, whereas positively valent stimuli come along with an immediate deceleration followed by a slight acceleration before decelerating again.
Measured: day 1 - 10
Questionnaire / structured interview on landscape preferences and meanings ascribed to landscapes (Meaning / Valence of Landscapes)
Further, qualitative interviews will be used to gain further insight into individual landscape preferences and valuation, bonds and relations to the perceived landscapes, as well as meanings and feelings people associate with the landscapes: Where they live? Where have they used to live? Do they have access to the landscapes? Do they spend time there?
Measured: day 0
Gaze patterns
To understand the process of observation and to connect the single changes in HRV and EDA with what the user is focusing at in the virtual reality scene, the investiagtors will use eye-tracking to record the eye movements. Using eye tracking helps to understand the visual attention and arousal of the user, due to analysing the fixations within a scene. Analysing the duration of fixations can help to interpret greater interest and emotional arousal. Lower numbers of fixations and saccades and longer fixation durations are observed in natural scenes compared to urban views. Additionally the environmental components of the restorative benefits can be explored using eye tracking. The investigators will use the HMD HTC Vive Pro Eye VR with integrated eye tracking powered by Tobii (120Hz Frequency, 0.5°-1.1° Accuracy). For the recording we will use scripts provided by Chamberlain et al. (2023).
Measured: day 1 - 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start23 Apr 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait AnalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ETH Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrike Wissen Hayek, Dr., Principal investigator, ETH Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304077
- Sponsor's protocol ID
- 2023-01894
- Other IDs
- 000005739, 2023
- Acronym
- REGaitVR
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06304077
- Acronym / sponsor ID
- REGaitVR / 2023-01894
- Conditions
- Gait Analysis, Virtual Reality, Attention, Stress
- Keywords
- virtual reality (VR) based gait therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- ETH ZurichUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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).
| Arm | Type | Receives |
|---|---|---|
| forest | Experimental | Other: Forestvirtual reality (VR) assisted gait therapy in a forest landscape |
| urban | Experimental | Other: Urbanvirtual reality (VR) assisted gait therapy in a urban landscape |
| rural | Experimental | Other: Ruralvirtual reality (VR) assisted gait therapy in a rural landscape |
| control | No intervention | –standard gait therapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ForestParticipants 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 aims at keeping the participant walking. | Other | forest |
| UrbanParticipants 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 aims at keeping the participant walking. | Other | urban |
| RuralParticipants 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 at keeping the participant walking. | Other | rural |
Primary outcome
Gait Stability
Time frame: at day 0 and day 11
The German version of the Activities-specific Balance Confidence (ABC) Scale is used to assess balance self-confidence in older people. Self-report of fear of falling correlates with performance on the blindfolded and one-legged tests, and in addition, fear of falling can lead to activity limitation, resulting in a decline in physical performance. It has a 11-point response scale (no confidence 0% - 100% completely confident) and the overall score it calculated by summing the scores and dividing by the number of items (16). Cut-off scores are < 50% (lower level of physical functioning), 50-80% (moderate level) and > 80% (high level), a score smaller than 67% indicated a risk for falling. The ABC scale can be complected within 5-10 minutes.It could show an internal consistency of the ABC scale of 0.94 and a test-retest reliability of 0.85 (95% CI, 0.68, 0.93).
17 secondary outcomes
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
Root Mean Square of Successive Differences (RMSSD) (Heart Rate Variability (HRV), Stress Reduction)
Time frame: day 0 - 11
LF/HF-ratio (Heart Rate Variability (HRV), Stress Reduction)
Time frame: day 0 - 11
Heart Rate change (ΔHR) (Meaning / Valence of Landscapes)
Time frame: day 1 - 10
Questionnaire / structured interview on landscape preferences and meanings ascribed to landscapes (Meaning / Valence of Landscapes)
Time frame: day 0
Gaze patterns
Time frame: day 1 - 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ulrike Wissen Hayek, Dr. principal investigator
ETH Zürich
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forest, Urban and Rural in people with Gait Analysis and Virtual Reality, run by ETH Zurich at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Schalbetter, MSc. (+41 (0)44 633 34 25, schalaur@ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Stability (time frame: at day 0 and day 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.