CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Multidisciplinary Conventional Neuromotor Rehabilitation +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05399043
NCT05399043N/ACompleted

Perception of High Technology in Rehabilitation: a Prospective Real-life Study on Usability, Effectiveness, and Health-related Quality of Life (PHTinRehab Study)

Istituti Clinici Scientifici Maugeri SpA·interventional·Posted Jun 1, 2022·Updated Apr 4, 2025

In Brief

A clinical study evaluating Multidisciplinary Conventional Neuromotor Rehabilitation and Technology-based Rehabilitation for Neurologic Diseases and 2 related conditions. Completed, enrolled 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 1, 2022
Enrollment StartSep 1, 2021
Primary CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.1 years ago

Interventions

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.