Neurologic DiseasesNCT05399043
Experience of Use and Biopsychosocial Effects of Robotic and Virtual Reality Devices in Neuromotor Rehabilitation
A study testing Multidisciplinary Conventional Neuromotor Rehabilitation and Technology-based Rehabilitation in people with Neurologic Diseases and Arthropathy of Knee, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
The implementation of virtual reality (VR) and robotic devices in neuromotor rehabilitation has so far provided promising evidence in terms of efficacy throughout different clinical populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurologic Diseases, Arthropathy of Knee, Arthropathy of Hip
- What is being tested?
- Multidisciplinary Conventional Neuromotor Rehabilitation and Technology-based Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- Diagnosis of acquired brain injury (ABI) or Parkinson's Disease (PD) or total knee/hip arthroplasty.
Who cannot join
- severe clinical condition (ie, chronic heart failure [New York Heart Association Classification-IV - NYHA-IV], ischemic heart disease [Canadian Cardiovascular Society Classification-IV - CCS-IV], neoplastic disease, acute respiratory disease);
- severe cognitive impairment (MoCA ≤ 15.5);
- language deficits;
- severe mental health condition or psychiatric disorder compromising participation in the study;
- absence or withdrawal of the informed consent to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perception of High Technology in Rehabilitation: a Prospective Real-life Study on Usability, Effectiveness, and Health-related Quality of Life (PHTinRehab Study)
The implementation of virtual reality (VR) and robotic devices in neuromotor rehabilitation has so far provided promising evidence in terms of efficacy throughout different clinical populations. Positive changes in patient's motor and functional outcomes were reported along with an increased autonomy in the activities of daily living (ADLs) and health-related quality of life (HRQoL). The experience of use of these technological devices and their impact on the cognitive and psychosocial outcomes remain still unclear, though. Adopting a biopsychosocial approach, the present two-arm, parallel, non-randomized prospective quasi-experimental study protocol aims to explore the short- and long-term effectiveness of robot-assisted therapy (RAT) and of VR-based neuromotor rehabilitation. Pre-post intervention effects will be estimated and compared between a group of patients undergoing conventional treatment and another group additionally participating in technology-based rehabilitation. The evaluation will include patient's functional status (ie, motor functionality, autonomy in ADLs, risk of falls), cognitive functioning (ie, attention and executive functions), HRQoL, and psychological aspects (ie, anxiety and depression symptoms, quality of life satisfaction). After the treatment, devices usability and experience of use, along with the related psychosocial impact will be also assessed.
Read the detailed description
Over the past two decades, the aging population and the related increase of acute and chronic diseases have led to the need for urgent healthcare solutions, including the implementation of interdisciplinary and innovative approaches in patients' care. Contextually, the field of neuromotor rehabilitation has shown deep interest in the deployment of robotic and virtual reality (VR) devices in recovery programs, given their multipurpose application.
Robot-assisted therapy (RAT) has reported promising evidence so far, showing advantages like the possibility to provide repetitive, intensive, and task-oriented rehabilitation activities, including the opportunity to implement smaller workforce, optimized exercise, and real-time quantitative motor assessment and monitoring. To date, diverse robot typologies (ie, exoskeletons, end-effectors, soft-robots) have been implemented to treat different chronic and complex diseases like acquired brain injury (ABI), spinal cord injury (SCI), multiple sclerosis (MS), and Parkinson's disease (PD) reporting evidence in favor of their feasibility and an improvement in patient functionality, autonomy and health-related quality of life (HRQoL).
Likewise, VR has been shown to be a promising tool to enhance rehabilitation outcomes. When various technical devices (eg, head-mounted displays, motion capture and tracking systems) are implemented, it can deliver realistic experiences by interacting with virtual environments (VEs) closely resembling everyday environments. To date, plenty of studies have tested and demonstrated the efficacy, for example, of VR-treadmill trainings for lower limbs, to improve gait and balance, ultimately reducing risk of falls, or of exercises in reaching and grasping virtual objects to target arms and manual movement, dexterity, and coordination. Besides, thanks to the multimodal and multisensory stimulation it can provides, VR has revealed to be an effective tool to obtain significant changes in cognitive outcomes (eg, memory, visual attention, executive functions). Lastly, such stimulation has been shown to have potential for increased patient engagement in the rehabilitation program, ultimately improving treatment compliance.
Nevertheless, alongside the technological devices' complexity and the related clinical application, ensuring adequate patient engagement and adherence to treatment still represents an open challenge. Accordingly, the introduction of technology in rehabilitation programs has raised the issue of devices usability and experience of use. Usability specifically refers to a patient's perception and ability to use a device effectively, efficiently, and satisfactorily. Factors like device ease-of-use and learnability are therefore essential when aiming to achieve adequate technology acceptance rate. Such factors, however, do not always sufficiently explain the complexity of the experience of use. To better expand the concept of device use, socio-cognitive and experiential factors (eg, emotions, motivation, satisfaction) need to be considered too.
In light of the data in the literature, beyond motor and functional recovery what has been scarcely addressed up to date is the potential of RAT and VR to improve patient's psychosocial functioning. Moreover, to optimally enhance technological devices deployment in rehabilitation programs, a deeper understanding on their experience of use is increasingly needed.
Following this line, the purpose of this study protocol is to explore, in a real-world clinical setting, both the experience of use and the biopsychosocial effectiveness of robotic and VR technology in patients undergoing neuromotor rehabilitation. In particular, this protocol outlines the procedures for exploring the perception and the effects of such technology across different neurological (ie, ABI, PD) and orthopedic (ie, total knee/hip arthroplasty) conditions and the implicit differences of the technological devices implemented. Accordingly, within/between-groups observations will be made as appropriate by considering consistent clinical populations and intervention procedures. Specifically, the study objectives are:
- to explore pre- post-treatment differences and long-term (6-month follow-up) effects concerning: patient's HRQoL, quality of life satisfaction, anxiety and depression symptoms, cognitive functioning, and functional status;
- to measure patient's perceived experience of the rehabilitation program, as well as the perceived experience of using the robotic and VR devices (user experience and device usability) and the related psychosocial impact;
- to observe the differences in terms of device experience of use in relation to the pathology, disease severity, and the type of device implemented;
- to extend the evaluation of the device's perceived usability to the therapists and explore to what extent this is associated to patient's perception of device usability and rehabilitation experience.
- Conditions
- Neurologic Diseases, Arthropathy of Knee, Arthropathy of Hip
- Being tested
- Multidisciplinary Conventional Neuromotor Rehabilitation, Technology-based Rehabilitation
- Keywords
- Acquired Brain Injury, Parkinson's Disease, Total Knee Arthroplasty, Total Hip Arthroplasty, Robot-Assisted Therapy, Virtual Reality, Health-related Quality of Life, Cognitive Functioning, Usability
- Medical subject headings
- Nervous System Diseases, Brain Injuries, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Conventional Neuromotor RehabilitationOther
Patients will receive conventional treatment consisting of two daily one-hour session (4 weeks) and including traditional rehabilitation activities like range of motion exercises (passive, active assisted and active), progressive resistive exercises, balance and strength training, and aerobic conditioning. The intervention procedures will follow the routine multidisciplinary clinical practice of the Institute where the study will be carried out. Procedures will be adapted according to patient's medical diagnosis, disability severity, and to the consequent rehabilitation objectives in favor of an individualized rehabilitation project and program. If necessary, patients might therefore undergo parallel rehabilitation activities (ie, occupational therapy, speech therapy, cognitive stimulation) that will be kept under control throughout data collection and analyses.
Technology-based RehabilitationDevice
According to their individualized rehabilitation project, patients will undergo RAT or non-immersive VR-based rehabilitation.
RAT will consist of three times a week one-hour session (4 weeks) and will be conducted by the implementation of an exoskeleton device for the upper limbs (Armeo-Spring™) or for the lower limbs (Lokomat™).
VR-based rehabilitation will consist of one daily one-hour session (4 weeks) and will be conducted by the implementation of a single non-immersive VR device among the Riablo™ (Corehab, Italy), the ProKin 252™ (TechnoBody SRL, Italy), the D-Wall™ (TechnoBody SRL, Italy), the Walker View™ (TechnoBody SRL, Italy).
Part of the duration of the whole treatment will be dedicated to the use of the device, resulting in the same amount of rehabilitation for all participants.
| Study group | Role | What they receive |
|---|---|---|
| Technology-based Rehabilitation Group | Experimental | Patients will undergo conventional treatment and, additionally, robot-assisted therapy or virtual reality-based rehabilitation. Receives: Other: Multidisciplinary Conventional Neuromotor Rehabilitation; Device: Technology-based Rehabilitation |
| Conventional Rehabilitation Group | Active comparator | Patients will undergo conventional treatment exclusively. Receives: Other: Multidisciplinary Conventional Neuromotor Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term changes in Modified Barthel Index (MBI)
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.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in Functional Independence Measure (FIM)
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).
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in Timed Up & Go Test (TUG)
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.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in Morse Fall Scale (MFS)
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.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in Montreal Cognitive Assessment (MoCA)
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.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in Symbol Digit Modalities Test (SDMT, oral version)
The symbol Digit Modalities Test (SDMT) evaluates speeded information processing, perceptual and motor speed, and visual scanning. Higher scores indicate better cognitive outcome.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in Trail Making Test (TMT)
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.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in Stroop Colour Word Test
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.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in Frontal Assessment Battery (FAB)
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.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in Phonemic Verbal Fluency Test
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.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in EuroQoL-VAS (EQ-VAS)
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.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in Short Form Health Survey-12 (SF-12)
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.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in Generalized Anxiety Disorder-7 (GAD-7)
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.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Short-term changes in The Satisfaction-Profile (SAT-P)
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.
Measured: From baseline (T0) to 4 weeks of rehabilitation (T1)
Client-Centred Rehabilitation Questionnaire (CCRQ)
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.
Measured: 4 weeks of rehabilitation (T1)
The Experience in Technology-based Rehabilitation Schedule (ExTR)
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.
Measured: 4 weeks of rehabilitation (T1)
Psychosocial Impact of Assistive Device Scale (PIADS)
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
Measured: 4 weeks of rehabilitation (T1)
System Usability Scale (SUS)
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.
Measured: 4 weeks of rehabilitation (T1)
Basic Activities of Daily Living (BADL)
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.
Measured: 6-month telephone follow-up (T2)
Instrumental Activities of Daily Living (IADL)
The Instrumental Activities of Daily Living (IADL) evaluates the patient's level of independence in performing more complex and instrumental activities (ie, using the telephone, making purchases, cooking, housekeeping, doing laundry, handling money, using means of transport, responsibility for his/her own medications). Total scores range from 0 to 8. Higher scores indicate higher patient's autonomy.
Measured: 6-month telephone follow-up (T2)
The telephone-based version of the MoCA (T-MoCA)
The telephone-based version of the MoCA (T-MoCA) evaluates patient's global cognition (ie, attention, short-term and delayed verbal memory, language, and orientation to time and space). Total scores range from 0 to 15. Higher scores indicate better cognitive outcome.
Measured: 6-month telephone follow-up (T2)
Long-term changes in EuroQoL-VAS (EQ-VAS)
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.
Measured: 6-month telephone follow-up (T2)
Long-term changes in Short Form Health Survey-12 (SF-12)
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.
Measured: 6-month telephone follow-up (T2)
Patient Health Questionnaire-4 (PHQ-4)
The Patient Health Questionnaire-4 (PHQ-4) evaluates patient's anxiety and depression symptoms severity in the last 2 weeks. Total scores range from 0 to 12. Higher scores indicate more severe anxiety and depression symptomatology.
Measured: 6-month telephone follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Sep 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neurologic DiseasesStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel, non-randomized prospective quasi-experimental study design
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca
- Responsible party
- Sponsor
- Investigators
- Antonia Pierobon, Dr., Principal investigator, Istituti Clinici Scientifici Maugeri, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399043
- Sponsor's protocol ID
- 2517
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zanatta F, Steca P, Fundaro C, Giardini A, Ferretti C, Arbasi G, Adorni R, D'Addario M, Pierobon A. Longitudinal evidence of technology-enhanced, individualized neuromotor rehabilitation on autonomy, cognition, quality of life, and psychological well-being: Pilot multi-sample study. PLoS One. 2026 Mar 13;21(3):e0344472. doi: 10.1371/journal.pone.0344472. eCollection 2026.
PubMed 41824405Zanatta F, Mancini D, Steca P, Panigazzi M, Prestifilippo E, Grilli C, D'Addario M, Pierobon A, Maffoni M. Effects of Exergame with Biofeedback Training on Functional Status, Cognition, and Quality of Life in Outpatients with Polyneuropathies: A Longitudinal Pilot Study. Brain Sci. 2025 Dec 29;16(1):45. doi: 10.3390/brainsci16010045.
PubMed 41594766Zanatta F, Steca P, Maffoni M, Fundaro C, Giardini A, Ferretti C, Arbasi G, D'Addario M, Pierobon A. Experience of use, usability and psychosocial impact of robotic and virtual reality technology in neuromotor rehabilitation: A mixed-method triangulation analysis of patients' and their therapists' perspective. Appl Ergon. 2025 Nov;129:104589. doi: 10.1016/j.apergo.2025.104589. Epub 2025 Jul 19.
PubMed 40684667Zanatta F, Steca P, Fundaro C, Giardini A, Felicetti G, Panigazzi M, Arbasi G, Grilli C, D'Addario M, Pierobon A. Biopsychosocial effects and experience of use of robotic and virtual reality devices in neuromotor rehabilitation: A study protocol. PLoS One. 2023 Mar 10;18(3):e0282925. doi: 10.1371/journal.pone.0282925. eCollection 2023.
PubMed 36897863Zanatta F, Farhane-Medina NZ, Adorni R, Steca P, Giardini A, D'Addario M, Pierobon A. Combining robot-assisted therapy with virtual reality or using it alone? A systematic review on health-related quality of life in neurological patients. Health Qual Life Outcomes. 2023 Feb 21;21(1):18. doi: 10.1186/s12955-023-02097-y.
PubMed 36810124Zanatta F, Giardini A, Pierobon A, D'Addario M, Steca P. A systematic review on the usability of robotic and virtual reality devices in neuromotor rehabilitation: patients' and healthcare professionals' perspective. BMC Health Serv Res. 2022 Apr 20;22(1):523. doi: 10.1186/s12913-022-07821-w.
PubMed 35443710
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of High Technology in Rehabilitation: a Prospective Real-life Study on Usability, Effectiveness, and Health-related Quality of Life (PHTinRehab Study)
- ClinicalTrials.gov ID
- NCT05399043
- Acronym / sponsor ID
- 2517
- Conditions
- Neurologic Diseases, Arthropathy of Knee, Arthropathy of Hip
- Keywords
- Acquired Brain Injury, Parkinson's Disease, Total Knee Arthroplasty, Total Hip Arthroplasty, Robot-Assisted Therapy, Virtual Reality, Health-related Quality of Life, Cognitive Functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- University of Milano Bicocca
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The implementation of virtual reality (VR) and robotic devices in neuromotor rehabilitation has so far provided promising evidence in terms of efficacy throughout different clinical populations. Positive changes in patient's motor and functional outcomes were reported along with an increased autonomy in the activities of daily living (ADLs) and health-related quality of life (HRQoL). The experience of use of these technological devices and their impact on the cognitive and psychosocial outcomes remain still unclear, though. Adopting a biopsychosocial approach, the present two-arm, parallel, non-randomized prospective quasi-experimental study protocol aims to explore the short- and long-term effectiveness of robot-assisted therapy (RAT) and of VR-based neuromotor rehabilitation. Pre-post intervention effects will be estimated and compared between a group of patients undergoing conventional treatment and another group additionally participating in technology-based rehabilitation. The evaluation will include patient's functional status (ie, motor functionality, autonomy in ADLs, risk of falls), cognitive functioning (ie, attention and executive functions), HRQoL, and psychological aspects (ie, anxiety and depression symptoms, quality of life satisfaction). After the treatment, devices usability and experience of use, along with the related psychosocial impact will be also assessed.
Detailed description
Over the past two decades, the aging population and the related increase of acute and chronic diseases have led to the need for urgent healthcare solutions, including the implementation of interdisciplinary and innovative approaches in patients' care. Contextually, the field of neuromotor rehabilitation has shown deep interest in the deployment of robotic and virtual reality (VR) devices in recovery programs, given their multipurpose application.
Robot-assisted therapy (RAT) has reported promising evidence so far, showing advantages like the possibility to provide repetitive, intensive, and task-oriented rehabilitation activities, including the opportunity to implement smaller workforce, optimized exercise, and real-time quantitative motor assessment and monitoring. To date, diverse robot typologies (ie, exoskeletons, end-effectors, soft-robots) have been implemented to treat different chronic and complex diseases like acquired brain injury (ABI), spinal cord injury (SCI), multiple sclerosis (MS), and Parkinson's disease (PD) reporting evidence in favor of their feasibility and an improvement in patient functionality, autonomy and health-related quality of life (HRQoL).
Likewise, VR has been shown to be a promising tool to enhance rehabilitation outcomes. When various technical devices (eg, head-mounted displays, motion capture and tracking systems) are implemented, it can deliver realistic experiences by interacting with virtual environments (VEs) closely resembling everyday environments. To date, plenty of studies have tested and demonstrated the efficacy, for example, of VR-treadmill trainings for lower limbs, to improve gait and balance, ultimately reducing risk of falls, or of exercises in reaching and grasping virtual objects to target arms and manual movement, dexterity, and coordination. Besides, thanks to the multimodal and multisensory stimulation it can provides, VR has revealed to be an effective tool to obtain significant changes in cognitive outcomes (eg, memory, visual attention, executive functions). Lastly, such stimulation has been shown to have potential for increased patient engagement in the rehabilitation program, ultimately improving treatment compliance.
Nevertheless, alongside the technological devices' complexity and the related clinical application, ensuring adequate patient engagement and adherence to treatment still represents an open challenge. Accordingly, the introduction of technology in rehabilitation programs has raised the issue of devices usability and experience of use. Usability specifically refers to a patient's perception and ability to use a device effectively, efficiently, and satisfactorily. Factors like device ease-of-use and learnability are therefore essential when aiming to achieve adequate technology acceptance rate. Such factors, however, do not always sufficiently explain the complexity of the experience of use. To better expand the concept of device use, socio-cognitive and experiential factors (eg, emotions, motivation, satisfaction) need to be considered too.
In light of the data in the literature, beyond motor and functional recovery what has been scarcely addressed up to date is the potential of RAT and VR to improve patient's psychosocial functioning. Moreover, to optimally enhance technological devices deployment in rehabilitation programs, a deeper understanding on their experience of use is increasingly needed.
Following this line, the purpose of this study protocol is to explore, in a real-world clinical setting, both the experience of use and the biopsychosocial effectiveness of robotic and VR technology in patients undergoing neuromotor rehabilitation. In particular, this protocol outlines the procedures for exploring the perception and the effects of such technology across different neurological (ie, ABI, PD) and orthopedic (ie, total knee/hip arthroplasty) conditions and the implicit differences of the technological devices implemented. Accordingly, within/between-groups observations will be made as appropriate by considering consistent clinical populations and intervention procedures. Specifically, the study objectives are:
- to explore pre- post-treatment differences and long-term (6-month follow-up) effects concerning: patient's HRQoL, quality of life satisfaction, anxiety and depression symptoms, cognitive functioning, and functional status;
- to measure patient's perceived experience of the rehabilitation program, as well as the perceived experience of using the robotic and VR devices (user experience and device usability) and the related psychosocial impact;
- to observe the differences in terms of device experience of use in relation to the pathology, disease severity, and the type of device implemented;
- to extend the evaluation of the device's perceived usability to the therapists and explore to what extent this is associated to patient's perception of device usability and rehabilitation experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel, non-randomized prospective quasi-experimental study design
| Arm | Type | Receives |
|---|---|---|
| Technology-based Rehabilitation Group | Experimental | Other: Multidisciplinary Conventional Neuromotor Rehabilitation, Device: Technology-based RehabilitationPatients will undergo conventional treatment and, additionally, robot-assisted therapy or virtual reality-based rehabilitation. |
| Conventional Rehabilitation Group | Active comparator | Other: Multidisciplinary Conventional Neuromotor RehabilitationPatients will undergo conventional treatment exclusively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older;
- Diagnosis of acquired brain injury (ABI) or Parkinson's Disease (PD) or total knee/hip arthroplasty.
Key exclusion criteria (5 listed)
- severe clinical condition (ie, chronic heart failure [New York Heart Association Classification-IV - NYHA-IV], ischemic heart disease [Canadian Cardiovascular Society Classification-IV - CCS-IV], neoplastic disease, acute respiratory disease);
- severe cognitive impairment (MoCA ≤ 15.5);
- language deficits;
- severe mental health condition or psychiatric disorder compromising participation in the study;
- absence or withdrawal of the informed consent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary Conventional Neuromotor RehabilitationPatients will receive conventional treatment consisting of two daily one-hour session (4 weeks) and including traditional rehabilitation activities like range of motion exercises (passive, active assisted and active), progressive resistive exercises, balance and strength training, and aerobic conditioning. The intervention procedures will follow the routine multidisciplinary clinical practice of the Institute where the study will be carried out. Procedures will be adapted according to patient's medical diagnosis, disability severity, and to the consequent rehabilitation objectives in favor of an individualized rehabilitation project and program. If necessary, patients might therefore undergo parallel rehabilitation activities (ie, occupational therapy, speech therapy, cognitive stimulation) that will be kept under control throughout data collection and analyses. | Other | Conventional Rehabilitation Group, Technology-based Rehabilitation Group |
| Technology-based RehabilitationAccording to their individualized rehabilitation project, patients will undergo RAT or non-immersive VR-based rehabilitation. RAT will consist of three times a week one-hour session (4 weeks) and will be conducted by the implementation of an exoskeleton device for the upper limbs (Armeo-Spring™) or for the lower limbs (Lokomat™). VR-based rehabilitation will consist of one daily one-hour session (4 weeks) and will be conducted by the implementation of a single non-immersive VR device among the Riablo™ (Corehab, Italy), the ProKin 252™ (TechnoBody SRL, Italy), the D-Wall™ (TechnoBody SRL, Italy), the Walker View™ (TechnoBody SRL, Italy). Part of the duration of the whole treatment will be dedicated to the use of the device, resulting in the same amount of rehabilitation for all participants. | Device | Technology-based Rehabilitation Group |
Primary outcome
Short-term changes in Modified Barthel Index (MBI)
Time frame: 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.
Short-term changes in Functional Independence Measure (FIM)
Time frame: 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).
Short-term changes in Timed Up & Go Test (TUG)
Time frame: 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.
Short-term changes in Morse Fall Scale (MFS)
Time frame: 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.
Short-term changes in Montreal Cognitive Assessment (MoCA)
Time frame: 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.
Short-term changes in Symbol Digit Modalities Test (SDMT, oral version)
Time frame: 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.
Short-term changes in Trail Making Test (TMT)
Time frame: 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.
Short-term changes in Stroop Colour Word Test
Time frame: 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.
Short-term changes in Frontal Assessment Battery (FAB)
Time frame: 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.
Short-term changes in Phonemic Verbal Fluency Test
Time frame: 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.
Short-term changes in EuroQoL-VAS (EQ-VAS)
Time frame: 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.
Short-term changes in Short Form Health Survey-12 (SF-12)
Time frame: 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.
Short-term changes in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 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.
Short-term changes in Patient Health Questionnaire-9 (PHQ-9)
Time frame: 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.
Short-term changes in The Satisfaction-Profile (SAT-P)
Time frame: 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.
Client-Centred Rehabilitation Questionnaire (CCRQ)
Time frame: 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.
The Experience in Technology-based Rehabilitation Schedule (ExTR)
Time frame: 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.
Psychosocial Impact of Assistive Device Scale (PIADS)
Time frame: 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
System Usability Scale (SUS)
Time frame: 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.
Basic Activities of Daily Living (BADL)
Time frame: 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.
Instrumental Activities of Daily Living (IADL)
Time frame: 6-month telephone follow-up (T2)
The Instrumental Activities of Daily Living (IADL) evaluates the patient's level of independence in performing more complex and instrumental activities (ie, using the telephone, making purchases, cooking, housekeeping, doing laundry, handling money, using means of transport, responsibility for his/her own medications). Total scores range from 0 to 8. Higher scores indicate higher patient's autonomy.
The telephone-based version of the MoCA (T-MoCA)
Time frame: 6-month telephone follow-up (T2)
The telephone-based version of the MoCA (T-MoCA) evaluates patient's global cognition (ie, attention, short-term and delayed verbal memory, language, and orientation to time and space). Total scores range from 0 to 15. Higher scores indicate better cognitive outcome.
Long-term changes in EuroQoL-VAS (EQ-VAS)
Time frame: 6-month telephone follow-up (T2)
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.
Long-term changes in Short Form Health Survey-12 (SF-12)
Time frame: 6-month telephone follow-up (T2)
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.
Patient Health Questionnaire-4 (PHQ-4)
Time frame: 6-month telephone follow-up (T2)
The Patient Health Questionnaire-4 (PHQ-4) evaluates patient's anxiety and depression symptoms severity in the last 2 weeks. Total scores range from 0 to 12. Higher scores indicate more severe anxiety and depression symptomatology.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Results publication: PubMed 41824405Zanatta F, Steca P, Fundaro C, Giardini A, Ferretti C, Arbasi G, Adorni R, D'Addario M, Pierobon A. Longitudinal evidence of technology-enhanced, individualized neuromotor rehabilitation on autonomy, cognition, quality of life, and psychological well-being: Pilot multi-sample study. PLoS One. 2026 Mar 13;21(3):e0344472. doi: 10.1371/journal.pone.0344472. eCollection 2026.
- Results publication: PubMed 41594766Zanatta F, Mancini D, Steca P, Panigazzi M, Prestifilippo E, Grilli C, D'Addario M, Pierobon A, Maffoni M. Effects of Exergame with Biofeedback Training on Functional Status, Cognition, and Quality of Life in Outpatients with Polyneuropathies: A Longitudinal Pilot Study. Brain Sci. 2025 Dec 29;16(1):45. doi: 10.3390/brainsci16010045.
- Results publication: PubMed 40684667Zanatta F, Steca P, Maffoni M, Fundaro C, Giardini A, Ferretti C, Arbasi G, D'Addario M, Pierobon A. Experience of use, usability and psychosocial impact of robotic and virtual reality technology in neuromotor rehabilitation: A mixed-method triangulation analysis of patients' and their therapists' perspective. Appl Ergon. 2025 Nov;129:104589. doi: 10.1016/j.apergo.2025.104589. Epub 2025 Jul 19.
- Results publication: PubMed 36897863Zanatta F, Steca P, Fundaro C, Giardini A, Felicetti G, Panigazzi M, Arbasi G, Grilli C, D'Addario M, Pierobon A. Biopsychosocial effects and experience of use of robotic and virtual reality devices in neuromotor rehabilitation: A study protocol. PLoS One. 2023 Mar 10;18(3):e0282925. doi: 10.1371/journal.pone.0282925. eCollection 2023.
- Results publication: PubMed 36810124Zanatta F, Farhane-Medina NZ, Adorni R, Steca P, Giardini A, D'Addario M, Pierobon A. Combining robot-assisted therapy with virtual reality or using it alone? A systematic review on health-related quality of life in neurological patients. Health Qual Life Outcomes. 2023 Feb 21;21(1):18. doi: 10.1186/s12955-023-02097-y.
- Results publication: PubMed 35443710Zanatta F, Giardini A, Pierobon A, D'Addario M, Steca P. A systematic review on the usability of robotic and virtual reality devices in neuromotor rehabilitation: patients' and healthcare professionals' perspective. BMC Health Serv Res. 2022 Apr 20;22(1):523. doi: 10.1186/s12913-022-07821-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia Pierobon, Dr. principal investigator
Istituti Clinici Scientifici Maugeri, IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary Conventional Neuromotor Rehabilitation and Technology-based Rehabilitation in people with Neurologic Diseases and Arthropathy of Knee, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term changes in Modified Barthel Index (MBI) (time frame: From baseline (T0) to 4 weeks of rehabilitation (T1)). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05399043, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.