Effectiveness of AOT Based on Virtual Reality in Stroke Rehabilitation.

NCT05163210 | Completed DMC

• 1 other identifier: SG-2019-12370506
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

action observation therapy; mirror neuron system; stroke; virtual reality; motor learning

Outcome Measures

Primary Outcomes (1)

• Change in Box and Block test (BBT) score between three time points

  BBT is a timed test for assessing upper limb dexterity and motor coordination. The test consists of 150 small wooden cubes (25 mm side) contained in a wooden box. The box is split in two equal compartments. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment to the other, within 60 seconds. The score is calculated as the number of blocks moved by the patient within 1 min, with the paretic hand. Score=0-100. Higher BBT scores between time points indicate a better outcome.

  Baseline (T0), after 5 weeks of treatment (T1) and after 6 months (T2).

Secondary Outcomes (4)

• Change in Modified Ashworth scale (MAS) score between three time points

  Baseline (T0), after 5 weeks of treatment (T1) and after 6 months (T2).

• Change in Motricity Index (MI) score between three time points

  Baseline (T0), after 5 weeks of treatment (T1) and after 6 months (T2).

• Change in Rankin Scale (RS) score between three time points

  Baseline (T0), after 5 weeks of treatment (T1) and after 6 months (T2).

• Change in Barthel Index (BI) score between three time points

  Baseline (T0), after 5 weeks of treatment (T1) and after 6 months (T2).

Other Outcomes (1)

• Change of functional Magnetic Resonance Imaging (fMRI) brain activation between two time points

  Baseline (T0) and after 5 weeks of treatment (T1).

Study Arms (2)

AO+VR

EXPERIMENTAL

Participants of the experimental group will undergo a treatment based on observation of actions followed by their immediate reproduction in VR (AO+VR treatment).

Behavioral: AO+VR

CO+VR

PLACEBO COMPARATOR

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.

Behavioral: CO+VR

Interventions

AO+VR BEHAVIORAL

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).

AO+VR

CO+VR BEHAVIORAL

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.

CO+VR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• severe cognitive impairment (score \<20 on MMSE);
• 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 severe untreated psychiatric disorders;
• sensory impairment hindering participation and/or not compensated visual deficits of central origin;
• drug-resistant epilepsy;
• presence of cognitive disability (IQ \< 65) controlled by administration of Wechsler Adult Intelligence Scale IV (WAIS-IV) (Wechsler, 2008).

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead
• Ministry of Health, Italy: collaborator

Study Sites (2)

Centro Cardinal Ferrari, Gruppo S. Stefano Riabilitazione

Parma, Emilia-Romagna, I-43012, Italy

Location

Istituto Clinico Quarenghi

Bergamo, Lombardy, I-24016, Italy

Location

Related Publications (5)

• Buchignani B, Beani E, Pomeroy V, Iacono O, Sicola E, Perazza S, Bieber E, Feys H, Klingels K, Cioni G, Sgandurra G. Action observation training for rehabilitation in brain injuries: a systematic review and meta-analysis. BMC Neurol. 2019 Dec 27;19(1):344. doi: 10.1186/s12883-019-1533-x.

  PMID: 31881854 BACKGROUND

• Ertelt D, Small S, Solodkin A, Dettmers C, McNamara A, Binkofski F, Buccino G. Action observation has a positive impact on rehabilitation of motor deficits after stroke. Neuroimage. 2007;36 Suppl 2:T164-73. doi: 10.1016/j.neuroimage.2007.03.043. Epub 2007 Mar 31.

  PMID: 17499164 BACKGROUND

• Rizzolatti G, Cattaneo L, Fabbri-Destro M, Rozzi S. Cortical mechanisms underlying the organization of goal-directed actions and mirror neuron-based action understanding. Physiol Rev. 2014 Apr;94(2):655-706. doi: 10.1152/physrev.00009.2013.

  PMID: 24692357 BACKGROUND

• Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.

  PMID: 29156493 BACKGROUND

• Errante A, Saviola D, Cantoni M, Iannuzzelli K, Ziccarelli S, Togni F, Simonini M, Malchiodi C, Bertoni D, Inzaghi MG, Bozzetti F, Menozzi R, Quarenghi A, Quarenghi P, Bosone D, Fogassi L, Salvi GP, De Tanti A. Effectiveness of action observation therapy based on virtual reality technology in the motor rehabilitation of paretic stroke patients: a randomized clinical trial. BMC Neurol. 2022 Mar 22;22(1):109. doi: 10.1186/s12883-022-02640-2.

  PMID: 35317736 DERIVED

MeSH Terms

Conditions

Stroke; Hemiplegia; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonino Errante, PhD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and their caregivers will be informed about the study aims and procedures, but they will be blinded to group allocation. In the case the patient asks for the presence of the caregiver, she/he will be seated near the participant but out of her/his view, without interfering during the treatment session. The therapist performing the intervention will not be blinded to the group allocation. Outcome assessments will be administered and scored by a member of the staff blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: This study will consist in a multicentric, randomized, allocation concealed (waitlist-controlled) and evaluator-blinded clinical trial (RCT) with two investigative arms, using an intensive rehabilitation program based on the combined use of AO followed by imitation in VR (AO+VR) (experimental intervention) compared to a control treatment based on observation of control videos followed by action execution in VR (CO+VR) (control intervention).

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 20, 2021
• Study Start: September 24, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 24, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)