Feasibility and Effects of a Realistic Stressful Virtual Environment on Balance and Mobility in Healthy Adults: A Pilot Study
NCT07931222, Not applicable, Completed, Vrije Universiteit Brussel
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Feasibility and Effects of a Realistic Stressful Virtual Environment on Balance and Mobility in Healthy Adults: A Pilot Study | ClinicalTrials.gov |
| NCT number | NCT07931222 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 11 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Vrije Universiteit Brussel | ClinicalTrials.gov |
| Conditions | Postural Balance, Healthy Adult, Mobility, Stress (Psychology) | ClinicalTrials.gov |
| Interventions | Immersive virtual reality exposure during balance and mobility assessment | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of participants completing all planned assessments | At the end of the single assessment session on Day 1, after completion or discontinuation of the planned assessments. | Proportion of participants who complete all planned assessments in both non-virtual reality (noVR) and virtual reality (VR) conditions. The predefined feasibility criterion is completion by at least 80% of participants. | ClinicalTrials.gov |
| Primary | Number of virtual reality-related technical issues | From the start of virtual reality system setup to the end of the virtual reality assessments during the single assessment session on Day 1. | technical feasibility: assessed by the number and type of VR-related technical issues encountered | ClinicalTrials.gov |
| Primary | Proportion of complete outcome measurements per test and condition | Data recording during all planned tests in the virtual reality and non-virtual reality conditions within the single assessment session on Day 1. | data completeness: quantified as the proportion of complete outcome data per test and condition (criterion: ≥80% complete data) | ClinicalTrials.gov |
| Primary | Percentage increase in assessment time with virtual reality compared with no virtual reality | From the start to the end of each assessment (mobility and balance assessments) in each condition (virtual reality and non-virtual reality) during the single assessment session on Day 1. | assessment burden: reflected by total assessment time, considered acceptable if VR assessments required no more than 20% additional time compared to noVR conditions | ClinicalTrials.gov |
| Primary | Number of participants experiencing adverse events during assessment | From the start of the assessment session until 15 minutes after its completion on Day 1, including both virtual reality and non-virtual reality assessments. | Number of participants experiencing at least one adverse event during the assessment session, including both virtual reality and non-virtual reality conditions, or within 15 minutes after its completion. | ClinicalTrials.gov |
| Primary | Virtual Reality Sickness Questionnaire scores (VRSQ) | single session, Immediately after completion of the virtual reality session on Day 1. | The VRSQ is a modified version of the Simulator Sickness Questionnaire and consists of nine items assessing symptoms of VR-induced discomfort. These items are grouped into two subdomains: oculomotor discomfort (items 1-4) and disorientation (items 5-9). Each item is rated on a four-point Likert scale ranging from 0 ("not at all") to 3 ("severe"). Subscale scores are normalized and combined to yield a total VRSQ score, with higher scores indicating greater VR sickness. | ClinicalTrials.gov |
| Secondary | iGroup Presence Questionnaire subscale scores | single session, Immediately after completion of the virtual reality session on Day 1. | The IPQ assesses different dimensions of presence and consists of items grouped into four subscales: General Presence (GP), Spatial Presence (SP), Involvement (INV), and Experienced Realism (ER). Items are rated on a seven-point Likert scale ranging from 0 to 6, with higher scores indicating a stronger sense of presence within the virtual environment. | ClinicalTrials.gov |
| Secondary | Within-participant difference in Mini-BESTest total score between virtual reality and non-virtual reality conditions | single session; During Mini-BESTest administration in each condition (virtual reality and non-virtual reality) within the single assessment session on Day 1. | The Mini-Balance Evaluation Systems Test (Mini-BESTest) is a standardized clinical assessment of dynamic balance and a shortened version of the Balance Evaluation Systems Test (BESTest). It consists of 14 items covering four balance domains: anticipatory postural adjustments (items 1-3), reactive postural control (items 4-6), sensory orientation (items 7-9), and dynamic gait (items 10-14) (A.3). Each item is scored on a three-level ordinal scale (0-2), resulting in a maximum total score of 28 points, with higher scores indicating better balance performance. For items requiring bilateral assessment (items 3 and 6), the lower score was retained. | ClinicalTrials.gov |
| Secondary | Within-participant difference in single-task and cognitive dual-task Timed Up and Go completion time between virtual reality and non-virtual reality conditions | single session; During single-task and cognitive dual-task Timed Up and Go testing in both conditions (virtual reality and non-virtual reality) within the single assessment session on Day 1. | Participants are instructed to stand up from a chair, walk three meters at a safe and comfortable speed, cross a marked line on the floor, turn around, walk back to the chair, and sit down. The time required to complete the task was recorded in seconds. In addition to the standard single-task TUG, a cognitive dual-task version was administered. During the dual-task TUG, participants were asked to count backwards by threes from a randomly selected number between 20 and 100 while performing the motor task. Both single-task and dual-task TUG were performed under noVR and VR conditions, resulting in four TUG conditions in total. | ClinicalTrials.gov |
| Secondary | Within-participant difference in comfortable walking speed between virtual reality and non-virtual reality conditions | single session; During comfortable walking speed testing in each condition (virtual reality and non-virtual reality) within the single assessment session on Day 1 | The 10-meter walk test was used to assess participants' walking speed. Participants started at the 0-meter (m) mark and walked to the 10 m mark. Timing was performed with a stop watch over the central 6 m, beginning 2 m after the start line and ending 2 m before the end line, to allow for acceleration and deceleration phases and to capture steady-state walking speed. Walking speed (m/s) was calculated by dividing the distance (6 m) by the recorded time (seconds). Two trials were performed at the participant's comfortable walking speed, followed by two trials at their fastest walking speed, according to standardized instructions. For each speed condition, the two trials were averaged, and the resulting comfortable and fast gait speeds were documented in meters per second. | ClinicalTrials.gov |
| Secondary | Within-participant difference in fast walking speed between virtual reality and non-virtual reality conditions | single session; During fast walking speed testing in each condition (virtual reality and non-virtual reality) within the single assessment session on Day 1. | The 10-meter walk test was used to assess participants' walking speed. Participants started at the 0-meter (m) mark and walked to the 10 m mark. Timing was performed with a stop watch over the central 6 m, beginning 2 m after the start line and ending 2 m before the end line, to allow for acceleration and deceleration phases and to capture steady-state walking speed. Walking speed (m/s) was calculated by dividing the distance (6 m) by the recorded time (seconds). Two trials were performed at the participant's comfortable walking speed, followed by two trials at their fastest walking speed, according to standardized instructions. For each speed condition, the two trials were averaged, and the resulting comfortable and fast gait speeds were documented in meters per second. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.