Effectiveness of AOT Based on Virtual Reality in Stroke Rehabilitation.

NCT05163210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-05-22

No results posted yet for this study

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.

Conditions

  • Stroke
  • Hemiplegia
  • Hemiparesis

Interventions

BEHAVIORAL

AO+VR

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).

BEHAVIORAL

CO+VR

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.

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV
  • Azienda Ospedaliero-Universitaria di Parma

    lead OTHER

Principal Investigators

  • Antonino Errante, PhD · Azienda Ospedaliero-Universitaria di Parma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-24
Primary Completion
2024-09-01
Completion
2024-09-24

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05163210 on ClinicalTrials.gov