Device for Driving Simulation for the Rehabilitation of Balance and Proprioception
NCT07539272, Not applicable, Not yet recruiting, University of Pavia
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Device for Driving Simulation for the Rehabilitation of Balance and Proprioception | ClinicalTrials.gov |
| NCT number | NCT07539272 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Pavia | ClinicalTrials.gov |
| Conditions | Neurological Disorders, Health Adult Subjects | ClinicalTrials.gov |
| Interventions | DriveSim Rehab, Conventional Rehabilitation | ClinicalTrials.gov |
| First posted | 2026-04-20 | ClinicalTrials.gov |
| Last updated | 2026-04-20 | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Evaluation of System Usability Scale (SUS) | Session 12 (end of treatment, Week 4) | System usability assessed with the System Usability Scale (SUS), a 10-item questionnaire using 5-point Likert responses to evaluate perceived usability of the device. The total score ranges from 0 to 100, with higher scores indicating better perceived usability. | ClinicalTrials.gov |
| Primary | Incidence of device-related adverse events | From Session 2 through Session 12 (up to 4 weeks) | Incidence defined as the number of participants with at least 1 device-related adverse event during the treatment period. Device-related adverse events reported by the participant or detected by the operator will be recorded on an ad hoc case report form at the end of each device-use session. | ClinicalTrials.gov |
| Primary | Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) mean total score | End of treatment (Session 12, Week 4) | Satisfaction and feasibility of the DriveSim Rehab system assessed with the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0), a 12-item questionnaire evaluating satisfaction with the assistive device and related services using a 5-point scale. Mean total score ranges from 1 to 5, with higher scores indicating greater satisfaction. | ClinicalTrials.gov |
| Primary | Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q) usability score | End of treatment (Session 12, Week 4). | Patient perception of technology-assisted rehabilitation assessed using the Usability domain of the Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q). The Usability domain includes 5 items scored on a 4-point Likert scale; total score ranges from 5 to 20, with higher scores indicating better perceived usability. | ClinicalTrials.gov |
| Primary | State-Trait Anxiety Inventory (STAI) state and trait anxiety scores | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4) | Anxiety levels assessed with the State-Trait Anxiety Inventory (STAI), a self-reported questionnaire that measures both state anxiety and trait anxiety. The State Anxiety and Trait Anxiety subscale scores each range from 20 to 80, with higher scores indicating greater anxiety. | ClinicalTrials.gov |
| Primary | Perceived Stress Scale (PSS) | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4). | Perceived stress assessed with the Perceived Stress Scale (PSS), a self-reported questionnaire used to evaluate the extent to which life situations are experienced as unpredictable, uncontrollable, and overwhelming. Total score ranges from 0 to 40, with higher scores indicating greater perceived stress. | ClinicalTrials.gov |
| Secondary | Berg Balance Scale (BBS) | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4). | The Berg Balance Scale is a 14-item clinical scale used to assess balance and postural stability. Each item is scored from 0 to 4, corresponding to a total score range of 0 to 56; higher scores indicate better balance performance. | ClinicalTrials.gov |
| Secondary | Timed Up and Go (TUG) | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4) | The Timed Up and Go test measures the time required for a participant to stand up from a chair, walk 3 meters, turn around a marker, walk back, and sit down. Lower completion time indicates better functional mobility and balance. | ClinicalTrials.gov |
| Secondary | 6-Minute Walk Test (6MWT) | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4) | The 6-Minute Walk Test is used to assess walking endurance and functional walking capacity. Greater walking distance indicates better walking performance. | ClinicalTrials.gov |
| Secondary | 10-Meter Walk Test (10MWT) | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4). | The 10-Meter Walk Test measures walking speed over a distance of 10 meters and is used to assess mobility. Higher walking speed indicates better mobility performance. | ClinicalTrials.gov |
| Secondary | Fugl-Meyer Assessment (FMA) | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4). | The Fugl-Meyer Assessment evaluates motor, sensory, and balance function in individuals with stroke or brain lesions. | ClinicalTrials.gov |
| Secondary | Psychosocial Impact of Assistive Devices Scale (PIADS) mean total score | End of treatment (Session 12, Week 4). | Psychosocial impact of the DriveSim Rehab system assessed with the Psychosocial Impact of Assistive Devices Scale (PIADS), a 26-item questionnaire evaluating competence, adaptability, and self-esteem. Mean total score ranges from -3 to +3, with higher scores indicating a more positive psychosocial impact of the device. | ClinicalTrials.gov |
| Secondary | EuroQol 5-Dimension (EQ-5D) visual analogue scale (EQ VAS) score | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4). | Health-related quality of life assessed with the EuroQol 5-Dimension (EQ-5D) questionnaire, including the EQ visual analogue scale (EQ VAS) for current health perception. EQ VAS score ranges from 0 to 100, with higher scores indicating better perceived health status. | ClinicalTrials.gov |
| Secondary | Trail Making Test Part A | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4). | Trail Making Test Part A assesses attention, concentration, and executive processing speed by requiring the participant to connect consecutive numbers as quickly as possible. Lower completion time indicates better performance. | ClinicalTrials.gov |
| Secondary | Stroop Test | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4). | The Stroop Test assesses concentration and cognitive flexibility by requiring the participant to name the ink color of printed words while inhibiting the automatic reading response. | ClinicalTrials.gov |
| Secondary | Digit Span Test | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4). | The Digit Span Test assesses working memory and attention by requiring the participant to repeat sequences of numbers. | ClinicalTrials.gov |
| Secondary | Mean driving speed during simulator tasks | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4). | Mean driving speed recorded by the simulator during driving tasks, used as an objective measure of speed control performance in participants exposed to DriveSim Rehab. | ClinicalTrials.gov |
| Secondary | Number of collisions and/or proximity events during simulator tasks | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4). | Number of collisions and/or proximity events recorded by the simulator during driving tasks, used as an objective measure of driving performance and environmental interaction. Lower values indicate better performance. | ClinicalTrials.gov |
| Secondary | Lane deviation during simulator tasks | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4). | Lane deviation recorded by the simulator during driving tasks, used as an objective measure of lane-keeping ability. Lower deviation indicates better driving control. | ClinicalTrials.gov |
| Secondary | Reaction time to simulated obstacles | Baseline (Session 1, Week 1) and end of treatment (Session 12, Week 4). | Reaction time recorded by the simulator as the time elapsed between the appearance of an obstacle and the participant's response using the steering wheel or brake. Lower reaction time indicates better performance. | 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 |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
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 |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
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.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)