nctId: NCT06304077 id: 2023-01894 id: 000005739 type: REGISTRY domain: Swiss National Clinical Trial Portal (SNCTP) briefTitle: Restorative Environments for Gait Therapy With VR acronym: REGaitVR overallStatus: RECRUITING date: 2024-03-01 date: 2025-02 date: 2025-02 date: 2024-03-12 date: 2024-03-12 name: ETH Zurich class: OTHER briefSummary: 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. conditions: Gait Analysis conditions: Virtual Reality conditions: Attention conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 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). primaryPurpose: TREATMENT masking: NONE count: 84 type: ESTIMATED name: Forest name: Urban name: Rural measure: Gait Stability measure: Variability (Gait Parameter) measure: Speed (Gait Parameter) measure: Asymmetry (Gait Parameter) measure: Stance (Gait Parameter) measure: Max. Heel Clearance (Gait Parameter) measure: 1-Minute-Sit-to-Stand Test (1-Min-STST) measure: Perceived Restorativeness Scale (PRS) (Attention Restoration) measure: Perceived Stress Scale (PSS) (Stress Reduction) measure: Skin Conductance Levels (SCL) (Stress Reduction) measure: Non-Specific Skin Conductance Responses (NS-SCRs) (Stress Reduction) measure: Event-related Skin Conductance Responses (ER-SCRs) (Stress Reduction) measure: Standard deviation of all NN (normal-to-normal) intervals (SDNN) (Heart Rate Variability (HRV), Stress Reduction) measure: Root Mean Square of Successive Differences (RMSSD) (Heart Rate Variability (HRV), Stress Reduction) measure: LF/HF-ratio (Heart Rate Variability (HRV), Stress Reduction) measure: Heart Rate change (ΔHR) (Meaning / Valence of Landscapes) measure: Questionnaire / structured interview on landscape preferences and meanings ascribed to landscapes (Meaning / Valence of Landscapes) measure: Gaze patterns measure: Age (Demographic data) measure: Height (Demographic data) measure: Weight (Demographic data) measure: Gender (Demographic data) measure: Education (Demographic data) measure: Diagnosis and reason for gait stability training measure: Time since last fall sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Geriatrische Klinik St. Gallen status: NOT_YET_RECRUITING city: St. Gallen state: Saint Gallen zip: 9000 country: Switzerland name: Dzuza Papik role: CONTACT phone: +41 (0)71 243 88 30 email: dzuza.papik@geriatrie-sg.ch lat: 47.42391 lon: 9.37477 facility: Spital Zollikerberg status: RECRUITING city: Zollikerberg state: Zürich zip: 8125 country: Switzerland name: Cor Dekker role: CONTACT phone: +41 (0)44 397 27 11 email: cor.dekker@therapien-zollikerberg.ch lat: 47.3451 lon: 8.60088 facility: Spitäler Schaffhausen status: NOT_YET_RECRUITING city: Schaffhausen zip: 8208 country: Switzerland name: Eliane Hepfer role: CONTACT phone: +41 (0)52 634 83 50 email: eliane.hepfer@spitaeler-sh.ch lat: 47.69732 lon: 8.63493 hasResults: False