Clinical trial NCT05399043: Experience of Use and Biopsychosocial Effects of Robotic and Virtual Reality Devices in Neuromotor Rehabilitation
Official title: Perception of High Technology in Rehabilitation: a Prospective Real-life Study on Usability, Effectiveness, and Health-related Quality of Life (PHTinRehab Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Usability
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: University of Milano Bicocca
First posted: 2022-06-01
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, parallel, non-randomized prospective quasi-experimental study design
Primary purpose: TREATMENT

Brief 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. 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:

1. 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;
2. 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;
3. to observe the differences in terms of device experience of use in relation to the pathology, disease severity, and the type of device implemented;
4. 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older;
* Diagnosis of acquired brain injury (ABI) or Parkinson's Disease (PD) or total knee/hip arthroplasty.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Short-term changes in Modified Barthel Index (MBI)
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in Functional Independence Measure (FIM)
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in Timed Up & Go Test (TUG)
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in Morse Fall Scale (MFS)
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in Montreal Cognitive Assessment (MoCA)
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in Symbol Digit Modalities Test (SDMT, oral version)
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in Trail Making Test (TMT)
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in Stroop Colour Word Test
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in Frontal Assessment Battery (FAB)
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in Phonemic Verbal Fluency Test
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in EuroQoL-VAS (EQ-VAS)
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in Short Form Health Survey-12 (SF-12)
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Short-term changes in The Satisfaction-Profile (SAT-P)
timeFrame: From baseline (T0) to 4 weeks of rehabilitation (T1)
measure: Client-Centred Rehabilitation Questionnaire (CCRQ)
timeFrame: 4 weeks of rehabilitation (T1)
measure: The Experience in Technology-based Rehabilitation Schedule (ExTR)
timeFrame: 4 weeks of rehabilitation (T1)
measure: Psychosocial Impact of Assistive Device Scale (PIADS)
timeFrame: 4 weeks of rehabilitation (T1)
measure: System Usability Scale (SUS)
timeFrame: 4 weeks of rehabilitation (T1)
measure: Basic Activities of Daily Living (BADL)
timeFrame: 6-month telephone follow-up (T2)
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: 6-month telephone follow-up (T2)
measure: The telephone-based version of the MoCA (T-MoCA)
timeFrame: 6-month telephone follow-up (T2)
measure: Long-term changes in EuroQoL-VAS (EQ-VAS)
timeFrame: 6-month telephone follow-up (T2)
measure: Long-term changes in Short Form Health Survey-12 (SF-12)
timeFrame: 6-month telephone follow-up (T2)
measure: Patient Health Questionnaire-4 (PHQ-4)
timeFrame: 6-month telephone follow-up (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri, IRCCS
state: PV
Study officials:
affiliation: Istituti Clinici Scientifici Maugeri, IRCCS
name: Antonia Pierobon, Dr.
role: PRINCIPAL_INVESTIGATOR
References: