Actively Recruiting

Age: 7Years - 25Years
All Genders
Healthy Volunteers
ID07369193

Immersive Action Observation Treatment with Multisensory Stimulation and Neurophysiological Measures in Children and Adolescents with Cerebral Palsy and Typical Development - A Pilot Study

Led by IRCCS Fondazione Stella Maris · Updated on 2026-04-02

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

I

IRCCS Fondazione Stella Maris

Lead Sponsor

U

University of Siena

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are exploring the Mirror Neuron System (MNS) and its role in rehabilitation techniques such as Action Observation Treatment (AOT) and Motor Imagery (MI), which activate neural circuits during movement observation or imagination. This pilot observational study focuses on children and adolescents with Cerebral Palsy (CP), the most common childhood motor disorder, and compares them with typically developing peers. The study aims to determine if a multisensory immersive AO session, combining visual, auditory, and tactile stimuli, produces stronger MNS activation than traditional visual-only AO sessions. Each participant will undergo two high-density Electroencephalography (hdEEG) sessions: one immersive session featuring first-person videos with matching auditory cues and tactile stimuli delivered by haptic gloves, and a traditional session showing videos without sound or touch. The order of these sessions will be randomized. During both sessions, participants will observe actions, then perform or imagine them, while eye tracking monitors their gaze and attention. Throughout each session, brain activity will be recorded with a 128-channel hdEEG net, and videos will capture motor responses and compliance. After each session, participants will complete motor imagery questionnaires and tasks assessing their ability to imagine actions. Data analysis will compare neurophysiological responses between immersive and traditional AO, and explore relationships between brain activity, attention, motor imagery, and clinical assessments for the CP group. Participation involves two one-hour sessions with detailed monitoring and questionnaire assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 7Years - 25Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • For the study group: confirmed diagnosis of cerebral palsy documented by clinical history and tests
  • Age between 7 and 25 years at recruitment
  • A verbal or nonverbal intellectual functioning index of 70 or higher
  • For the control group: age between 7 and 25 years
  • No intellectual disability based on age-appropriate Raven's Progressive Matrices tests
  • Age-appropriate academic performance with no significant learning difficulties
  • No known neurological or psychiatric disorders
  • No motor impairments, scoring above the 25th percentile on a motor assessment
Not Eligible

You will not qualify if you...

  • Severe sensory disorders that prevent study participation
  • Neuropsychiatric conditions that preclude involvement in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single session lasting approximately one hour

Participants undergo neurophysiological assessments including high-density EEG and attention and motor imagery data collection.

1 visit (in-person)

Long-term Monitoring

Duration - Up to study completion date in June 2027

Participants are observed for neurophysiological changes over time without active intervention.

Additional assessments may occur depending on cohort assignment

Trial Site Locations

Total: 1 location

1

IRCCS Fondazione Stella Maris

Calambrone, Pisa, Italy, 56128

Actively Recruiting

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Research Team

G

Giuseppina Sgandurra, PhD, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Neurocognitive mechanisms underlying social learning in infancy: infants' neural processing of the effects of others' actions.

Markus Paulus, Sabine Hunnius, Harold Bekkering

https://pubmed.ncbi.nlm.nih.gov/22689219

State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy.

Iona Novak, Catherine Morgan, Michael Fahey...

https://pubmed.ncbi.nlm.nih.gov/32086598