NCT05399043Completed
Experience of Use and Biopsychosocial Effects of Robotic and Virtual Reality Devices in Neuromotor Rehabilitation
Perception of High Technology in Rehabilitation: a Prospective Real-life Study on Usability, Effectiveness, and Health-related Quality of Life (PHTinRehab Study)
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 22 Apr 2022
- Start date
- 1 Sept 2021
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Diseases
- Parkinson disease
- NCT number
- NCT05399043
What you commit to
- Study type: Interventional
- Participants enrolled: 84
- From 1 Sept 2021 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
- severe mental health condition or psychiatric disorder compromising participation in the study;
Other
- language deficits;
- absence or withdrawal of the informed consent to participate.
Who the study is looking for
- 18 years of age or older;
- Diagnosis of acquired brain injury (ABI) or Parkinson's Disease (PD) or total knee/hip arthroplasty.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituti Clinici Scientifici Maugeri IRCCS Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.