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