Restorative Environments for Gait Therapy with VR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorETH Zurich
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age: > 65 years
german-speaking
ability to give informed consent
attends gait safety training (usual care)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Forest
Other interventionParticipants 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.
Urban
Other interventionParticipants 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.
Rural
Other interventionParticipants 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.
Treatment groups
84 Participants
are divided into 4 treatment groupsGroup A: forestExperimental treatment 1 intervention
Group B: urbanExperimental treatment 1 intervention
Group C: ruralExperimental treatment 1 intervention
Group D: controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
at day 0 and day 11Secondary outcomes
1
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.
Time frame
day 0 - 112
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.
Time frame
day 0 - 113
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.
Time frame
day 0 - 114
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.
Time frame
day 0 - 11Other outcomes
1
Age (Demographic data)
Age have been shown to influence heart rate responses to stress. Gait is affected by age.
Time frame
day 02
Height (Demographic data)
Gait is affected by height.
Time frame
day 03
Weight (Demographic data)
Gait is affected by weight
Time frame
day 04
Gender (Demographic data)
These data will be used to analyse the study results for differences in gender. Gender have been shown to influence heart rate responses to stress
Time frame
day 0 Source ClinicalTrials.gov