Experience of Use and Biopsychosocial Effects of Robotic and Virtual Reality Devices in Neuromotor Rehabilitation

NCT ID: NCT05399043

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-11-30

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.

Conditions

Neurologic Diseases; Arthropathy of Knee; Arthropathy of Hip

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Technology-based Rehabilitation Group

Patients will undergo conventional treatment and, additionally, robot-assisted therapy or virtual reality-based rehabilitation.

Group Type: EXPERIMENTAL

Multidisciplinary Conventional Neuromotor Rehabilitation

Intervention Type: OTHER

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 Rehabilitation

Intervention Type: DEVICE

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.

Conventional Rehabilitation Group

Patients will undergo conventional treatment exclusively.

Group Type: ACTIVE_COMPARATOR

Multidisciplinary Conventional Neuromotor Rehabilitation

Intervention Type: OTHER

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.

Interventions

Multidisciplinary Conventional Neuromotor Rehabilitation

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.

Intervention Type: OTHER

Technology-based Rehabilitation

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milano Bicocca

OTHER

Sponsor Role: collaborator

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Antonia Pierobon

Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonia Pierobon, Dr.

Role: PRINCIPAL_INVESTIGATOR

Istituti Clinici Scientifici Maugeri, IRCCS

Locations

Istituti Clinici Scientifici Maugeri, IRCCS

Pavia, PV, Italy

Countries

Italy

References

Zanatta 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.

Reference Type: DERIVED

PMID: 36897863 (View on PubMed)

Other Identifiers

2517

Identifier Type: -

Identifier Source: org_study_id