NCT05163210Completed
Effectiveness of AOT Based on Virtual Reality in Stroke Rehabilitation.
Effectiveness of Action Observation Therapy Based on Virtual Reality Technology in Motor Rehabilitation of Paretic Stroke Patients: a Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 22 May 2025
Brief summary (registry, in English)
Rehabilitation of paretic stroke patients, aimed to improve function of the impaired upper limb, uses a wide range of intervention programs. A new rehabilitative approach, called Action Observation Therapy (AOT), based on the discovery of mirror neurons, has been used to improve motor functions of adult stroke patients and children with cerebral palsy. Recently, Virtual Reality (VR) provided the potential to increase the frequency and the effectiveness of rehabilitation treatment and offered challenging and motivating tasks. The purpose of the present project is to design a randomized, controlled, six-month follow-up trial (RCT) for evaluating whether action observation (AO) added to standard VR (AO+VR) is effective in improving upper limb function in patients with stroke, compared with a control treatment consisting in observation of naturalistic scenes (CO) devoid of action content, followed by VR training (CO+VR). The AO+VR treatment may represent an extension of the current rehabilitative interventions available for recovery after stroke and the outcome of the project could allow to include this treatment within the standard sensorimotor training or in individualized tele-rehabilitation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 23 Nov 2021
- Start date
- 24 Sept 2021
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Diseases
- Stroke
- NCT number
- NCT05163210
What you commit to
- Study type: Interventional
- Participants enrolled: 48
- From 24 Sept 2021 to the primary completion date, 1 Sept 2024
- 2 sites 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 cognitive impairment (score \<20 on MMSE);
- presence of severe untreated psychiatric disorders;
- sensory impairment hindering participation and/or not compensated visual deficits of central origin;
- drug-resistant epilepsy;
Other
- presence of severe forms of unilateral spatial neglect (Bells Test, cut-off =/\> 50% ).
- presence of severe anosognosia;
- presence of severe language comprehension deficits assessed by clinical examination;
- presence of cognitive disability (IQ \< 65) controlled by administration of Wechsler Adult Intelligence Scale IV (WAIS-IV) (Wechsler, 2008).
Who the study is looking for
- primarily motor symptoms with unilateral upper limb paresis (controlled via standard neurological examination);
- residual movement ability of the paretic upper limb, controlled by Medical Research Council (MRC) index \> 2 and \< 4, active use of the hemiplegic limb, from minimal (mainly for assistance tasks to the preserved limb) to discrete (characterized by coarse manipulation and an inability to perform precision grip);
- sufficient cooperation and cognitive understanding to participate in the activities, controlled by the investigator recruiting the patient.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Clinico Quarenghi Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Centro Cardinal Ferrari, Gruppo S. Stefano Riabilitazione Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.