CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
AO+VR +1 morebehavioral
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/NCT05163210
NCT05163210N/ACompleted

Effectiveness of Action Observation Therapy Based on Virtual Reality Technology in Motor Rehabilitation of Paretic Stroke Patients: a Randomized Clinical Trial

Azienda Ospedaliero-Universitaria di Parma·interventional·Posted Dec 20, 2021·Updated May 22, 2025

In Brief

A clinical study evaluating AO+VR and CO+VR for Stroke and 2 related conditions. Completed, enrolled 48 participants across 2 sites.

Detailed Summary

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.

Study Details

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

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 20, 2021
Enrollment StartSep 24, 2021
Primary CompletionSep 1, 2024
Study CompletionSep 24, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 4.5 years ago

Interventions

AO+VRbehavioral

The experimental treatment will consist of 15 hours (min. 15, max. 20), and will be carried out 4 days/week for a total duration of 5 weeks. During the rehabilitation sessions, the patient will be instructed to carefully watch videos lasting about 1.5 minutes, presented on Liquid Crystal Display (LCD) monitor, consisting in unimanual or bimanual actions performed by an actor, from a lateral perspective. Subsequently, the patient will be asked to imitate the actions presented for at least 3 consecutive times, within a time window of 3 min., using the same objects observed in the video, in a virtual scenario (VR), through the Khymeia Virtual Reality Rehabilitation System (VRRS).

CO+VRbehavioral

Patients of the control group will be required to observe videos depicting naturalistic scenes, without motor contents, for 1.5 min. Then, they will receive a motor training in the VR environment, performing the same type of exercises included in the above-described experimental treatment, prompted by the verbal instructions of an expert therapist. Thus, the general setting for carrying out the rehabilitation sessions will be identical to that of the experimental treatment, except for the fact that the control group will not be involved in action observation before preforming the exercises. Thus, the control treatment is not based on action imitation, but on purely motor execution.