A Multicenter Interventional Study on the Use of a 3-Degree-of-Freedom (3DOF) Platform to Evaluate the Safety and Usability of the System and Its Impact on Balance, Proprioception, and Neurological Deficits in the Rehabilitation of Patients With Neurological Disorders.
NCT07502937, 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 | A Multicenter Interventional Study on the Use of a 3-Degree-of-Freedom (3DOF) Platform to Evaluate the Safety and Usability of the System and Its Impact on Balance, Proprioception, and Neurological Deficits in the Rehabilitation of Patients With Neurological Disorders. | ClinicalTrials.gov |
| NCT number | NCT07502937 | 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 | 3DOF balance board robotic platform group, Conventional Rehabilitation | ClinicalTrials.gov |
| First posted | 2026-03-31 | ClinicalTrials.gov |
| Last updated | 2026-04-06 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of Adverse Events | From the first session to the end of the intervention, up to 4 weeks | Safety of the 3DoF platform for participants and operators will be assessed by recording the incidence and frequency of adverse events reported by the participant or observed by the operator during each study session. Adverse events include, for example, falls or episodes of instability during platform use, post-exercise musculoskeletal pain, technical malfunctions of the platform, dizziness or nausea related to vestibular stimulation or virtual reality, and premature interruption of the session by the participant or therapist. | ClinicalTrials.gov |
| Primary | Evaluation of System Usability Scale (SUS) | Session 12 (final evaluation, Week 4). | SUS consists of a series of 10 questions, which users answer using a 5-point Likert scale ranging from "strongly disagree" to "strongly agree." The questions are designed to assess various aspects of usability, such as ease of use, complexity and user satisfaction. Total score ranges from 0 to 100, with higher scores indicating better usability. | ClinicalTrials.gov |
| Primary | Evaluation of Quality of Care Through the Patient's Eyes (QUEST) 2.0 | Session 12 (final evaluation, Week 4). | This QUEST 2.0 questionnaire is used to assess patient satisfaction with healthcare services. "QUEST" stands for "Quality of Care Through the Patient's Eyes" and was developed to measure patients' perceptions of the quality of healthcare services and support. Version 2.0 is an update of the original questionnaire designed to make it more comprehensive and suitable for various healthcare settings. Reported as total questionnaire score; higher scores indicate greater satisfaction with the device and related services. | ClinicalTrials.gov |
| Primary | Evaluation of Technology Assisted Rehabilitation Patient Perception Questionnaire | Session 12 (final evaluation, Week 4). | To assess the patient perception of the technology assisted rehabilitation using the Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q). The TARPP-Q consists of 10 questions with multiple choice answers, totalling 29 items. The Questionnaire assesses patients' personal experiences and perceptions of technology assisted rehabilitation, including aspects like usability, positive attitude, hindrance perception, and distress. Reported as total questionnaire score; higher scores indicate a more positive perception of technology-assisted rehabilitation. | ClinicalTrials.gov |
| Primary | Change from baseline in State-Trait Anxiety Inventory | Baseline (Session 1) and Session 12 (final evaluation, Week 4) | STAI: This stands for "State-Trait Anxiety Inventory," a psychometric questionnaire used to assess anxiety levels in adults. There are two versions of the questionnaire: one measures state anxiety (momentary, situational) and the other measures trait anxiety (stable, dispositional). Total score ranges from 20 to 80, with higher scores indicating greater anxiety. | ClinicalTrials.gov |
| Primary | Change From Baseline in Perceived Stress Scale (PSS) | Baseline (Session 1) and Session 12 (final evaluation, Week 4) | Change in self-reported stress related to the activity performed during device use, assessed with the Perceived Stress Scale (PSS). Higher scores indicate greater perceived stress. | ClinicalTrials.gov |
| Secondary | Change from baseline in Berg Balance Scale | Baseline (Session 1) and Session 12 (final evaluation, Week 4) | Change in balance performance assessed with the Berg Balance Scale (BBS). The BBS evaluates balance and stability across 14 tasks. . Total score ranges from 0 to 56, with higher scores indicating better balance performance. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Timed Up and Go (TUG) | Baseline (Session 1) and Session 12 (final evaluation, Week 4) | Change in mobility and balance assessed with the Timed Up and Go (TUG) test, defined as the time required to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Lower values indicate better performance. | ClinicalTrials.gov |
| Secondary | Change From Baseline in 6-Minute Walk Test (6MWT) | Baseline (Session 1) and Session 12 (final evaluation, Week 4) | Change in functional walking capacity assessed with the 6-Minute Walk Test (6MWT), defined as the distance walked in 6 minutes. Higher values indicate better performance. | ClinicalTrials.gov |
| Secondary | Change From Baseline in 10-Meter Walk Test (10MWT) | Baseline (Session 1) and Session 12 (final evaluation, Week 4) | Change in gait performance assessed with the 10-Meter Walk Test (10MWT), used to evaluate walking speed over 10 meters. Higher values indicate better performance. Time Frame: | ClinicalTrials.gov |
| Secondary | Change From Baseline in Fugl-Meyer Assessment Score | Baseline (Session 1) and Session 12 (final evaluation, Week 4) | Change in motor, sensory, and balance function assessed with the Fugl-Meyer Assessment. Higher scores indicate better neurological function. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Exergame Path Completion Time | Baseline (Session 1) and Session 12 (final evaluation, Week 4) | Change in device-recorded performance during the exergame, defined as the time required to complete the exergame path, measured in seconds. Lower values indicate better performance. | ClinicalTrials.gov |
| Secondary | Change From Baseline in quality of life (EuroQol-5D) | Baseline (Session 1) and Session 12 (final evaluation, Week 4) | Change in health-related quality of life assessed with the EuroQol-5D (EQ-5D). Score ranges from 0 to 100, with higher scores indicating better perceived health status. | ClinicalTrials.gov |
| Secondary | Psychosocial Impact of Assistive Devices Scale (PIADS) | Session 12 (final evaluation, Week 4) | Psychosocial impact of the device assessed at the end of treatment with the Psychosocial Impact of Assistive Devices Scale (PIADS), including perceived effects on functional capability, self-efficacy, and participation. Higher scores indicate a more positive psychosocial impact of the device. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Trail Making Test Part A Performance | Baseline (Session 1) and Session 12 (final evaluation, Week 4) | Change in cognitive performance assessed with Trail Making Test Part A. Lower values indicate better performance. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Stroop Test Performance | Baseline (Session 1) and Session 12 (final evaluation, Week 4) | Change in cognitive performance assessed with the Stroop Test. Higher scores indicate better cognitive performance. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Digit Span Test Score | Baseline (Session 1) and Session 12 (final evaluation, Week 4) | Change in working memory and attention assessed with the Digit Span Test. Higher scores indicate better working memory performance. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Target Collection Accuracy | Baseline (Session 1, Week 1) and Session 12 (Week 4) | Change in device-recorded exergame performance, defined as the percentage of targets successfully collected during the task. Higher values indicate better performance. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Obstacle Avoidance Accuracy | Baseline (Session 1, Week 1) and Session 12 (Week 4) | Change in device-recorded exergame performance, defined as the percentage of obstacles correctly avoided during the task. Higher values indicate 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)