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

Status: Completed
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Istituto Clinico Quarenghi
Bergamo
Centro Cardinal Ferrari, Gruppo S. Stefano Riabilitazione
Parma
Time Frame
Start Date: 2021-09-24
Completion Date: 2024-09-24
Participants
Target number of participants: 48
Treatments
Experimental: AO+VR
Participants of the experimental group will undergo a treatment based on observation of actions followed by their immediate reproduction in VR (AO+VR treatment).
Placebo_comparator: CO+VR
Participants randomly assigned to the control group will receive an equal number of rehabilitation sessions, as the experimental group. Differently from the latter, 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.
Sponsors
Leads: Azienda Ospedaliero-Universitaria di Parma
Collaborators: Ministry of Health, Italy

This content was sourced from clinicaltrials.gov