Experience of Use and Biopsychosocial Effects of Robotic and Virtual Reality Devices in Neuromotor Rehabilitation
NCT05399043, Not applicable, Completed, Istituti Clinici Scientifici Maugeri SpA
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Experience of Use and Biopsychosocial Effects of Robotic and Virtual Reality Devices in Neuromotor Rehabilitation | ClinicalTrials.gov |
| NCT number | NCT05399043 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 84 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Istituti Clinici Scientifici Maugeri SpA | ClinicalTrials.gov |
| Conditions | Neurologic Diseases, Arthropathy of Knee, Arthropathy of Hip | ClinicalTrials.gov |
| Interventions | Multidisciplinary Conventional Neuromotor Rehabilitation, Technology-based Rehabilitation | ClinicalTrials.gov |
| First posted | 2022-06-01 | ClinicalTrials.gov |
| Last updated | 2026-10-16 | ClinicalTrials.gov |
Registered outcomes 25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Short-term changes in Modified Barthel Index (MBI) | From baseline (T0) to 4 weeks of rehabilitation (T1) | The Modified Barthel Index (MBI) evaluates patient's autonomy to perform ADLs (ie, chair/bed transfer, ambulation, stair climbing, toilet transfer, bowel control, bladder control, bathing, dressing, personal hygiene, feeding). Total scores range from 0 to 100. Higher scores indicate higher patient's autonomy. | ClinicalTrials.gov |
| Primary | Short-term changes in Functional Independence Measure (FIM) | From baseline (T0) to 4 weeks of rehabilitation (T1) | The Functional Independent Measure (FIM) evaluates patient's disability level according to motor and cognitive subscores. Total scores range from 18 (complete dependence) to 126 (complete independence). Two subscores can be calculated: FIM motor (range 13-91) and FIM cognitive (range 5-35). | ClinicalTrials.gov |
| Primary | Short-term changes in Timed Up & Go Test (TUG) | From baseline (T0) to 4 weeks of rehabilitation (T1) | The Timed Up \& Go Test measures patient's risk of falling, static and dynamic balance by estimating the time patient takes to stand up from an armchair, walk forward for 3 meters, turn, walk back to the chair and sit down. The longer the time this takes, the higher the risk of falling. | ClinicalTrials.gov |
| Primary | Short-term changes in Morse Fall Scale (MFS) | From baseline (T0) to 4 weeks of rehabilitation (T1) | The Morse Falls Scale (MFS) evaluates patient's risk of falls. Total scores ranges from 0 to 125 with higher scores reflecting a greater risk of falling. | ClinicalTrials.gov |
| Primary | Short-term changes in Montreal Cognitive Assessment (MoCA) | From baseline (T0) to 4 weeks of rehabilitation (T1) | The Montreal Cognitive Assessment (MoCA) test evaluates patient's global cognition (ie, visuospatial abilities, executive functions, attention, concentration, short-term and delayed verbal memory, working memory, language, orientation to time and space). Total scores range from 0 to 30. Higher scores indicate better cognitive outcome. | ClinicalTrials.gov |
| Primary | Short-term changes in Symbol Digit Modalities Test (SDMT, oral version) | From baseline (T0) to 4 weeks of rehabilitation (T1) | The symbol Digit Modalities Test (SDMT) evaluates speeded information processing, perceptual and motor speed, and visual scanning. Higher scores indicate better cognitive outcome. | ClinicalTrials.gov |
| Primary | Short-term changes in Trail Making Test (TMT) | From baseline (T0) to 4 weeks of rehabilitation (T1) | The Trail Making Test (TMT) measures psychomotor speed and visual search attention (ie, visual scanning, graphomotor speed, and visuomotor processing speed), and executive functions (ie, working memory, inhibition control). TMT scores represent the time spent to complete the task and are provided in seconds. The higher the scores, the worse is the performance. | ClinicalTrials.gov |
| Primary | Short-term changes in Stroop Colour Word Test | From baseline (T0) to 4 weeks of rehabilitation (T1) | The Stroop Colour Word Test evaluates selective attention, cognitive flexibility and inhibition, and sensitivity to interference. Final score is obtained by computing the time interference effect (based on execution time) and the error interference effect (based on number of errors). Lower scores indicate better cognitive outcome. | ClinicalTrials.gov |
| Primary | Short-term changes in Frontal Assessment Battery (FAB) | From baseline (T0) to 4 weeks of rehabilitation (T1) | The Frontal Assessment Battery (FAB) evaluates executive functions (ie, conceptualization, verbal fluency, motor programming and executive control of action, self-regulation, resistance to interference, inhibitor control, environmental autonomy). Total scores range from 0 to 18. Higher scores indicate better cognitive outcome. | ClinicalTrials.gov |
| Primary | Short-term changes in Phonemic Verbal Fluency Test | From baseline (T0) to 4 weeks of rehabilitation (T1) | The Phonemic Verbal Fluency Test evaluate phonemic fluency by asking the patient to generate as many words as possible beginning with a specific letter. Higher scores indicate better cognitive outcome. | ClinicalTrials.gov |
| Primary | Short-term changes in EuroQoL-VAS (EQ-VAS) | From baseline (T0) to 4 weeks of rehabilitation (T1) | The EuroQoL-VAS (EQ-VAS) evaluates self-rated health on a vertical visual analogue scale (0: the worst health you can imagine; 100: the best health you can imagine). Higher scores indicate better health-related quality of life. | ClinicalTrials.gov |
| Primary | Short-term changes in Short Form Health Survey-12 (SF-12) | From baseline (T0) to 4 weeks of rehabilitation (T1) | The Short Form Survey-12 (SF-12) evaluates perceived physical health and mental health. Two subscores are generated, namely the physical component summary (PCS) and the mental component summary (MCS). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. | ClinicalTrials.gov |
| Primary | Short-term changes in Generalized Anxiety Disorder-7 (GAD-7) | From baseline (T0) to 4 weeks of rehabilitation (T1) | The Generalized Anxiety Disorder-7 (GAD-7) evaluates anxiety symptoms severity in the last 2 weeks. Total scores range from 0 to 21. Higher scores indicate more severe anxiety. | ClinicalTrials.gov |
| Primary | Short-term changes in Patient Health Questionnaire-9 (PHQ-9) | From baseline (T0) to 4 weeks of rehabilitation (T1) | The Patient Health Questionnaire-9 (PHQ-9) evaluates depression symptoms severity in the last 2 weeks. Total scores range from 0 to 21. Higher scores indicate more severe depression. | ClinicalTrials.gov |
| Primary | Short-term changes in The Satisfaction-Profile (SAT-P) | From baseline (T0) to 4 weeks of rehabilitation (T1) | The Satisfaction-Profile (SAT-P) evaluates patient's satisfaction with three different domains associated with HRQoL (ie, mood, resistance to physical fatigue, and mental efficiency) evaluated on a 10-cm horizontal visual analogue scale ranging from "extremely dissatisfied" to "extremely satisfied" (in the last month). Higher rates indicate higher patient's satisfaction. | ClinicalTrials.gov |
| Primary | Client-Centred Rehabilitation Questionnaire (CCRQ) | 4 weeks of rehabilitation (T1) | The Client-Centred Rehabilitation Questionnaire (CCRQ) evaluates patient's subjective experience of care in rehabilitation settings (ie, patient participation in decision making and goal setting, patient-centred education, evaluation of outcomes from the patient's perspective, family involvement, emotional support, co-ordination/continuity, physical comfort). Total scores range from 33 to 165. Higher scores indicate better rehabilitation experience. | ClinicalTrials.gov |
| Primary | The Experience in Technology-based Rehabilitation Schedule (ExTR) | 4 weeks of rehabilitation (T1) | The Experience in Technology-based Rehabilitation Schedule (ExTR) is an ad-hoc questionnaire measuring patients' experience of use of the devices. Specifically, technology learnability, acceptability, usefulness, adaptability, adverse effects, engagement, enjoyment, safety, and perceived effectiveness. Total scores range from 0 to 60. Higher scores indicate better patient's experience of use of the devices. | ClinicalTrials.gov |
| Primary | Psychosocial Impact of Assistive Device Scale (PIADS) | 4 weeks of rehabilitation (T1) | The Psychosocial Impact of Assistive Device Scale (PIADS) evaluates the psychosocial impact of the technological devices. Each item is scored on a 7-point Likert scale. The score is meant to be either positive (+1, +2, +3 scores) or negative (-1, -2, -3 scores), with a central tendency marked as zero that indicates no perceived change after using the device. Higher scores reflect the technological device's stronger psychosocial impact | ClinicalTrials.gov |
| Primary | System Usability Scale (SUS) | 4 weeks of rehabilitation (T1) | The System Usability Scale (SUS) evaluates perceived device usability (ie, devices ease-of-use and learnability). Total scores range from 0 to 100. Higher scores indicate higher usability. | ClinicalTrials.gov |
| Primary | Basic Activities of Daily Living (BADL) | 6-month telephone follow-up (T2) | The Basic Activities of Daily Living (BADL) evaluates patient's level of independence in the basic activities in relation to the daily environment (ie, bathing, dressing, toilet, continence, transferring, feeding). Total scores range from 0 to 6. Higher scores indicate higher patient's autonomy. | 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 6
The papers the trial lists on ClinicalTrials.gov.
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 5
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 | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary 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)