Immersive AOT: Multisensory Stimulation and Neurophysiological Correlates in Children With Cerebral Palsy and Typical Development - A Pilot Study (ImmersiveAOT)

April 1, 2026 updated by: Giuseppina Sgandurra, IRCCS Fondazione Stella Maris

Immersive AOT: Multisensory Stimulation and Neurophysiological Correlates - A Pilot Study

The discovery of the Mirror Neuron System (MNS) has promoted the development of rehabilitation techniques such as Action Observation Treatment (AOT) and Motor Imagery (MI). These are based on the principle that neural circuits active during execution, also activate during the observation or imagination of movements. These techniques have been found to be effective in several clinical populations including children with Cerebral Palsy (CP), the most common childhood-onset motor disorder. We hypothesize that a multimodal version of AOT, integrating not only visual stimuli (standard practice) but also auditory and tactile stimuli, could further enhance the activation of the MNS. In fact, everyday actions naturally involve multiple sensory channels, and evidence indicate that audio-visual action observation activates the MNS more intensely than visual stimuli alone, thus offering a potential improvement for CP rehabilitation.

The primary aim of this observational pilot study, conducted at IRCCS Fondazione Stella Maris, is to verify whether a multisensory (=immersive) AO session - combining visual, auditory, and tactile stimuli - produces greater activation of the MNS, than a traditional session (visual AO alone). Neural correlates will be measured through high-density Electroencephalography (hdEEG), with a specific focus on the modulation of the sensorimotor mu rhythm. Twenty children and adolescents with CP, aged 7-25 years, and 20 typically developing (TD) aged-matched peers will be recruited in the study. The study also aims to assess the level of participants' attention during stimuli presentation through eye tracking, and to verify whether immersive AO can influence MI abilities, measured through specific tasks and questionnaires (i.e., Motor Imagery Questionnaire for Children (MIQ-C, aged 7-12) and the Motor Imagery Questionnaire - 3 (MIQ-3) for adolescent). In an initial phase of the study both questionnaires will be the validated in a separate sample of 120 TD Italian children and 120 Italian adolescents or adults. The absence of intellectual disability will be assessed using the age-appropriate version of Raven's Progressive Matrices test.

Each participant will undergo two EEG sessions: the immersive session will consist of watching first-person videos accompanied by auditory stimuli consistent with the action and tactile stimuli provided by TouchDIVER Pro haptic gloves (Weart, CE-marked device), suitably adapted for the paediatric population. The traditional session will consist of watching videos without sounds or any tactile additional stimulus. The two sessions will be performed in a in random order. In both sessions, after the observation phase, participants will be asked to perform or imagine the same actions presented in the videos. During observation, eye movements and gaze behavior will be monitored using an eye tracking system. Throughout each session, cortical activity will be recorded using a 128-channel hdEEG net. The sessions will be video-recorded to accurately monitor participants motor behavior, response times, and compliance with the protocol.

At the end of each EEG session, participants will be administered the MIQ-C or MIQ-3 questionnaire and a short task to assess MI abilities. In this task, participants will watch some of the videos previously used during the EEG session and will then be asked to imagine the same action. In this case, their imagery will be interrupted at specific time points, and they will be asked to select, from two images, the moment of the action corresponding to the point at which they were interrupted.

Data analysis will examine within- and between-groups differences for the immersive AO vs the traditional AO. Correlation analysis will be also performed between neurophysiological data, attentional data, questionnaires, MI responses and standardized clinical assessments ( for the CP group), in order to understand how the participants' motor and cognitive abilities influence the activation of the circuits involved in the experimental tasks.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Pisa
      • Calambrone, Pisa, Italy, 56128
        • Recruiting
        • IRCCS Fondazione Stella Maris
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

For this study, 20 children, adolescents, and young adults with typical development will be recruited (community sample), toghether with 20 children and adolescents diagnosed with CP (recruit at the IRCCS Fondazione Stella Maris).

Description

Study Group: Inclusion Criteria:

  • Confirmed diagnosis of cerebral palsy, documented by clinical history and instrumental examinations;
  • Age between 7 and 25 years at the time of recruitment;
  • At least one verbal or nonverbal intellectual functioning index >= 70, to ensure understanding and compliance with the tasks required.

Exclusion Criteria:

  • Severe sensory disorders that compromise the feasibility of the study;
  • Neuropsychiatric comorbidity that precludes participation in the study.

Control group: Inclusion Criteria

  • Age between 7 and 25 years at the time of recruitment;
  • Absence of intellectual disability, assessed through age-appropriate versions of the Raven's Progressive Matrices (Coloured Progressive Matrices for children up to 11 years; Standard Progressive Matrices for participants aged 12 years and older), yielding scores within the normative range and used to estimate non-verbal fluid intelligence;
  • Age-appropriate academic performance with no reports of significant learning difficulties, as verified through parental interview;
  • Absence of known neurological or psychiatric disorders, confirmed through parental interview;
  • Absence of motor impairments, defined as scoring above the 25th percentile on the Movement Assessment Battery for Children, Second Edition (MABC-2).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1 (Study Group)
20 participants aged 7-25 years diagnosed with Cerebral Palsy (CP)
Group 2 (Control Group)
20 participants with typical development (TD) aged 7-25

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurophysiological data (hdEEG)
Time Frame: one hour per session
The primary outcome will be represented by the neurophysiological data obtained from the two recording sessions. Spectral and time-frequency analyses will be performed to examine the reactivity of specific frequency bands (e.g., sensorimotor mu rhythm and attentional alpha rhythm) in relation the presented stimuli. Event-related desynchronization/synchronization (ERD/ERS) patterns will be compared across sessions and between groups.
one hour per session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attention and motor imagery data
Time Frame: One hour per session
Secondary outcomes will be represented by data on participants' attention (eye tracker) and MI. Analysis of data obtained from the eye tracking will focus on eye movements, stimulus fixation duration, and saccadic movements during video viewing. Scores from the MIQ-C and MIQ-3 questionnaires and the MI task results will also be included. These data will compared across sessions and between groups. Also, aorrelation analyses with EEG data will be performed.
One hour per session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Fondazione Stella Maris

Collaborators

University of Siena, Italy

Investigators

  • Principal Investigator: Giuseppina Sgandurra, PhD, MD, IRCCS Fondazione Stella Maris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ImmersiveAOT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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