Restorative Environments for Gait Therapy with VR

NCT06304077 | Recruiting

• 2 other identifiers: 2023-01894000005739
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

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.

Conditions

Gait Analysis; Virtual Reality; Attention; Stress

Keywords

virtual reality (VR) based gait therapy

Outcome Measures

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).

  at day 0 and day 11

Secondary Outcomes (17)

• Variability (Gait Parameter)

  day 0 - 11

• Speed (Gait Parameter)

  day 0 - 11

• Asymmetry (Gait Parameter)

  day 0 - 11

• Stance (Gait Parameter)

  day 0 - 11

• Max. Heel Clearance (Gait Parameter)

  day 0 - 11

Other Outcomes (7)

• Age (Demographic data)

  day 0

• Height (Demographic data)

  day 0

• Weight (Demographic data)

  day 0

Study Arms (4)

forest

EXPERIMENTAL

virtual reality (VR) assisted gait therapy in a forest landscape

Other: Forest

urban

EXPERIMENTAL

virtual reality (VR) assisted gait therapy in a urban landscape

Other: Urban

rural

EXPERIMENTAL

virtual reality (VR) assisted gait therapy in a rural landscape

Other: Rural

control

NO INTERVENTION

standard gait therapy

Interventions

Forest OTHER

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.

forest

Urban OTHER

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.

urban

Rural OTHER

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.

rural

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• minute walking distance: \> 30 m without rest, with or without walking aids, overground walking on flat surface

You may not qualify if:

• 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.

Sponsors & Collaborators

• ETH Zurich: lead

Study Sites (3)

Spitäler Schaffhausen

Schaffhausen, Canton of Schaffhausen, 8208, Switzerland

NOT YET RECRUITING

Geriatrische Klinik St. Gallen

Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

NOT YET RECRUITING

Spital Zollikerberg

Zollikerberg, Canton of Zurich, 8125, Switzerland

RECRUITING

MeSH Terms

Interventions

Forests

Intervention Hierarchy (Ancestors)

Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Ulrike Wissen Hayek, Dr.

  ETH Zürich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Schalbetter, MSc.

CONTACT

+41 (0)44 633 34 25; schalaur@ethz.ch

Ulrike Wissen Hayek, Dr.

CONTACT

+41 (0)44 633 30 07; ulrike.wissen@ethz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 12, 2024
• Study Start: April 23, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)