Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients
NCT07616050, Not applicable, Not yet recruiting, Marta Mondellini
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients | ClinicalTrials.gov |
| NCT number | NCT07616050 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 70 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Marta Mondellini | ClinicalTrials.gov |
| Conditions | Post-stroke, Parkinson Disease, Amyotrophic Lateral Sclerosis, Mild Cognitive Impairment (MCI), Multiple Sclerosis, Frailty at Older Adults | ClinicalTrials.gov |
| Interventions | Dual-task training with Virtual Reality, Cycling training | ClinicalTrials.gov |
| First posted | 2026-05-29 | ClinicalTrials.gov |
| Last updated | 2026-05-29 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Intrinsic Motivation | Baseline, Week 2, Week 5 | It is evaluated with the Interest/Enjoyment subscale of the Intrinsic Motivation Inventory (IMI). It is a part of a questionnaire, composed of 7 items to be answered on a 7-point Likert scale. For each statement, participants must provide a level of agreement on a scale of 1 to 7, where 1 equals "strongly disagree" and 7 equals "strongly agree." . Total scores range from 7 to 49, with higher scores indicating greater intrinsic motivation and enjoyment during rehabilitation training. | ClinicalTrials.gov |
| Primary | Motivation | Baseline, Week 2, Week 5 | the patient's motivational spectrum is assessed using the Situational Motivation Scale (SIMS), a self-report questionnaire. It consists of 16 items rated on a 7-point Likert scale and investigates four factors: intrinsic motivation, identified regulation, external regulation, and amotivation. For each statement, participants must provide a level of agreement on a scale of 1 to 7, where 1 equals "strongly disagree" and 7 equals "strongly agree." . Total scores range from 4 to 28 on each subscale, with higher scores indicating greater presence of that type of motivation towards rehabilitation activity. | ClinicalTrials.gov |
| Secondary | Usability | Week 2 or Week 5 | evaluated with the System Usability Scale (SUS); it is a post-study questionnaire consisting of 10 questions answered on a 5-point Likert scale. For each statement, participants must provide a level of agreement on a scale of 1 to 5, where 1 equals "strongly disagree" and 5 equals "strongly agree." The SUS results in a score ranging from 0 to 100, allowing not only an assessment of a system's usability but also its comparison with other systems. Higher scores indicate higher perceived usability of the system. For each statement, participants must provide a level of agreement on a scale of 1 to 5, where 1 equals "strongly disagree" and 5 equals "strongly agree." | ClinicalTrials.gov |
| Secondary | user experience in relation to the adoption of the proposed technology | Week 2 or Week 5 | assessed with the Technology-Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q). The instrument consists of 29 items and explores the following factors: perceived usability, positive emotions, feelings of obstacle/difficulty, and feelings of stress. The items are to be answered on a 4-point Likert scale, where 1 corresponds to "not at all" and 4 to "very much". Higher scores indicate a more positive user experience. | ClinicalTrials.gov |
| Secondary | Cognitive Function | Baseline, week 2, week 5, week 9 | Trail Making Test A-B is designed to assess selective, sustained, and divided attention, as well as any deficits in visual-motor coordination. In Trail Making Test A, the subject must match all 25 numbers on the sheet of paper in ascending order as quickly as possible. If the subject is able to complete the first part of the test, Trail Making Test B can be administered. It is administered in the same way, but the subject must match numbers and letters alternating between them as quickly as possible. This test allows for an assessment of psychomotor speed, visuospatial search ability, selective memory, and selective attention. Results include completion time in seconds. Lower completion times indicate better cognitive performance. | ClinicalTrials.gov |
| Secondary | Cognitive Function | Baseline, Week 2, Week 5, Week 9 | The Short Stroop Test is one of the most commonly used tests to assess prefrontal functions such as cognitive flexibility and the control and inhibition of automatic responses. It is a timed test divided into three parts: in the first part, the subject must name the color of the squares presented to them; in the second part, they must simply read the words written on the board (color names); and in the third part, they are asked to name the color of the ink the words are written in (the board presents a series of color names, each printed in a different color than the one indicated by the name). The third part is reported by subjects as the most difficult. The Stroop effect emphasizes the interference that automatic word processing generates on the color-naming task, which is more demanding in terms of mental effort. Outcome include execution time and number of errors. Lower scores indicate better performance. | ClinicalTrials.gov |
| Secondary | Cognitive Function | Baseline, Week 2, Week 5, Week 9 | The Frontal Assessment Battery (FAB) is a screening test that assesses the presence and severity of a dysexecutive disorder affecting both cognition and motor behavior. The test consists of six subtests that explore, in order: the ability to conceptualize and abstract categories, mental flexibility, motor planning ability, sensitivity to interference, inhibition control, and environmental autonomy. The total score is the sum of the individual subtest scores and ranges from 0 to 18 (cut-off 13.50/18). Higher scores indicate better executive functioning. | ClinicalTrials.gov |
| Secondary | Cognitive Function | Baseline, Week 2, Week 5, Week 9 | Corsi Forward - Backward is a test designed to assess working memory and short-term visuospatial memory. The examiner places a board of nine cubes in front of the subject, which the subject will touch in sequences of increasing length. The subject must reproduce the sequence in the same order (Forward) or in reverse (Backward). Starting with a sequence of three cubes, the number of cubes the subject must memorize gradually increases. Outcome include the number of cubes correctly memorized. Higher scores indicate better visuospatial memory performance. | ClinicalTrials.gov |
| Other | Motor Function | Up to 5 weeks | Workload on the cycle ergometer | ClinicalTrials.gov |
| Other | Motor Funcion | Up to 5 weeks | Cycling assistance level | ClinicalTrials.gov |
| Other | Motor function | Up to 5 weeks | Cycling distance traveled during cycling training, measured in meters using ergometer-derived data | ClinicalTrials.gov |
| Other | Functional abilities | Baseline, Week 2, Week 5 | The Modified Barthel Index (MBI) is a clinical tool used to assess independence in activities of daily living (ADLs) in patients with physical disabilities. The MBI evaluates ten specific functions: Feeding, Bathing, Grooming, Dressing, Bowel control, Bladder control, Toileting, Transfers (e.g., bed to chair), Mobility (e.g., walking or wheelchair use), Stair climbing. Each item is scored on a 5-level ordinal scale. Interpretation: 0-20, Total dependency; 21-60, Severe dependency; 61-90, Moderate dependency; 91-99, Slight dependency; 100, Independence | ClinicalTrials.gov |
| Other | exercise tolerance | Up to 5 weeks | The Borg RPE scale (Rating of Perceived Exertion, 6-20) is used: ranges from 6 (minimal effort) to 20 (maximum effort) and is often used to assess the intensity of effort in sports and rehabilitation. This scale is widely used in the medical and sports fields to monitor patients' perceived exertion during rehabilitation exercises or physical activities. | ClinicalTrials.gov |
| Other | exercise tolerance | Up to 5 weeks | Heart rate measured with finger pulse oximeter with medically certified devices | ClinicalTrials.gov |
| Other | Exercise Tolerance | Up to 5 weeks | Oxygen saturation measured with finger pulse oximeter with medically certified devices | ClinicalTrials.gov |
| Other | Device Security | Up to 5 weeks | The number and description of any adverse events that occurred and were attributable to the use of the device will be collected. | 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 29
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 2489825 | BACKGROUND | PubMed |
| 2760661 | BACKGROUND | PubMed |
| 7129724 | BACKGROUND | PubMed |
| 11113214 | BACKGROUND | PubMed |
| 11456302 | BACKGROUND | PubMed |
| 11464847 | BACKGROUND | PubMed |
| 20511101 | BACKGROUND | PubMed |
| 22689311 | BACKGROUND | PubMed |
| 26474316 | BACKGROUND | PubMed |
| 28841846 | BACKGROUND | PubMed |
| 29098620 | BACKGROUND | PubMed |
| 30029502 | BACKGROUND | PubMed |
| 30327596 | BACKGROUND | PubMed |
| 30535956 | BACKGROUND | PubMed |
| 30558556 | BACKGROUND | PubMed |
| 31607362 | BACKGROUND | PubMed |
| 32104516 | BACKGROUND | PubMed |
| 32452880 | BACKGROUND | PubMed |
| 34184168 | BACKGROUND | PubMed |
| 35069171 | BACKGROUND | PubMed |
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 |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | 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)