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

NCT05399043 | Completed

• 1 other identifier: 2517
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (25)

• 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.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  6-month telephone follow-up (T2)

Study Arms (2)

Technology-based Rehabilitation Group

EXPERIMENTAL

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

Other: Multidisciplinary Conventional Neuromotor Rehabilitation; Device: Technology-based Rehabilitation

Conventional Rehabilitation Group

ACTIVE COMPARATOR

Patients will undergo conventional treatment exclusively.

Other: Multidisciplinary Conventional Neuromotor Rehabilitation

Interventions

Multidisciplinary Conventional Neuromotor Rehabilitation 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.

Conventional Rehabilitation Group; Technology-based Rehabilitation Group

Technology-based Rehabilitation 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.

Technology-based Rehabilitation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• University of Milano Bicocca: collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri, IRCCS

Pavia, PV, 27100, Italy

Location

Related Publications (1)

• 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.

  PMID: 36897863 DERIVED

MeSH Terms

Conditions

Nervous System Diseases; Brain Injuries; Parkinson Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Antonia Pierobon, Dr.

  Istituti Clinici Scientifici Maugeri, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Model Details: Two-arm, parallel, non-randomized prospective quasi-experimental study design

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: June 1, 2022
• Study Start: September 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 4, 2025

Record last verified: 2023-09

Locations

IT (1)