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NCT05399043

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

Completed NA Last updated 4 April 2025
What this trial tests

NA trial testing Multidisciplinary Conventional Neuromotor Rehabilitation in Neurologic Diseases in 84 participants. Completed in 30 November 2023.

Timeline
1 September 2021
Primary endpoint
30 November 2023
30 November 2023

Quick facts

Lead sponsorIstituti Clinici Scientifici Maugeri SpA
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment84
Start date1 September 2021
Primary completion30 November 2023
Estimated completion30 November 2023
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Who can join

18 and older, any sex, with Neurologic Diseases or Arthropathy of Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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