Neural Correlates of Goal-directed Action Observation and Execution in Children With Unilateral Cerebral Palsy (EEG_AINCP)

January 16, 2026 updated by: Giuseppina Sgandurra, IRCCS Fondazione Stella Maris

Neurophysiological, Kinematics and Functional Correlates of Goal-directed Action Observation and Execution in Children With Unilateral Cerebral Palsy

Cerebral palsy (CP) is the most common childhood-onset motor disorder, with Unilateral Cerebral Palsy (UCP)- motor impairment predominantly impacting one side of the body-representing the most frequent form of CP. Among available rehabilitation programs, Action Observation Treatment (AOT) has gained increasing attention for its demonstrated effectiveness in improving manual motor function. AOT involves the systematic observation of goal-directed actions followed by their execution/imitation and is thought to leverage the mirror mechanism and its role in motor learning. Specifically, it relies on the neurophysiological principle that observing others' actions activates the same neural structures involved in executing those actions, reflecting the engagement of the mirror neuron system (MNS). In children with CP, the feasibility and effectiveness of AOT have been shown functionally (Sgandurra et al., 2013, Buchignani et al., 2019). However, despite its theoretical grounding in MNS functioning, the neurophysiological correlates of this system in children with CP remain less characterized, with only limited investigations using functional neuroimaging (e.g., Sgandurra et al., 2020) or neurophysiological methods such as electroencephalography (EEG; e.g., Demas et al., 2019).

This observational study aims to characterize the neurophysiological signatures of action execution and action observation in children aged 5-15 years with a diagnosis of UCP compared to a group of age-matched typically developing (TD) peers. To this end, non-invasive high-density EEG (hdEEG) will be used to quantify sensorimotor cortex modulation through mu-rhythm reactivity-specifically event-related desynchronization (ERD) and synchronization (ERS)-and its topographical distribution during an active visuo-motor task involving upper limbs. Mu-rhythm desynchronization (or suppression) over sensorimotor regions is a well-established marker of MNS engagement. A secondary objective is to examine the relationship between EEG measures and participants' attention, upper-limb kinematics, and manual motor function. To this purpose, participants will wear non-invasive wearable sensors to capture arm/hand kinematics, and attention will be monitored with a non-invasive eye-tracking system. Validated scales will be used to assess manual motor function.

Participants will take part in one single visit of about 1.5 hours. During the EEG acquisition session, children will wear a 128-channel EEG net and complete an active visuo-motor paradigm including the observation and execution of unimanual and bimanual goal-directed actions (e.g., reaching-grasping). In the observation condition, children will watch videos depicting these actions on a computer screen while refraining from movement. In the subsequent execution condition, they will interact themselves with the same objects as in the observation condition. Throughout the same session, children's attention/gaze will be tracked via eye-tracking, and upper-limb kinematics will be recorded using wearable inertial measurement unit (IMU) sensors. Before or after EEG acquisition, manual motor function will be assessed using two standardized scales: the Assisting Hand Assessment (AHA) and the Melbourne Assessment-2 (MA-2).

Data analysis will characterize the mu rhythm ERD topography and temporal dynamics during both action execution and action observation, within and between groups. Correlation analyses will explore associations between neurophysiological measures, gaze and attentional patterns, kinematic data, and motor assessments scores to elucidate how motor and attentional factors modulate sensorimotor cortical activation.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

80

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

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

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children with Unilateral CP (study group) - recruited at the IRCCS Fondazione Stella Maris Typically developing children (control group) - community sample

Description

Children with Unilateral Cerebral Palsy

Inclusion Criteria:

  • Children with confirmed diagnosis of Unilateral Cerebral Palsy,
  • Manual ability levels from I to III in the Manual Ability Classification System (MACS);
  • Children's age from 5 to 15 years old.

Exclusion Criteria:

  • Severe Upper Limb (UpL) impairment (MACS ≥ level IV: inability to grasp),
  • UpL surgery within 12 months prior to study entry and botulinum toxin injection within 6 months prior to study entry,
  • Severe comobordities,
  • Severe cognitive disability, clinically assessed by the cognitive scales Wechsler, Preschool and Primary Scale of Intelligence (WPPSI-IV) or Wechsler Intelligence Scale for Children (WISC-IV or V).

Typically Developing children:

Inclusion Criteria

  • 5 to 15 year-old children with typical development,
  • No documented clinically relevant disorders

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
Study Group
40 children with Unilateral Cerebral Palsy (UCP), aged 5-15 years
Control Group
40 typically developing (TD) children, aged 5-15 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurophysiological (EEG) data
Time Frame: 1 session - about 45 minutes

- Mu-rhythm reactivity during the EEG action-observation task.

Primary outcome measures will be the EEG mu rhythm modulation during the visuo-motor task performed by participants. The EEG mu rhythm suppression (or desynchronization) is an index of the human mirror neuron system activation over the sensorimotor cortex.

Quantitative Spectral and time-frequency analyses will be performed to assess mu-rhythm suppression in response to executed and observed goal-directed actions.

Mu rhythm event-related desynchronization/synchronization (ERD/ERS) patterns will be examined across scalp regions (primary region of interest: central and parietal sites) and conditions (observation, execution) and compared between groups (control group vs study group).
1 session - about 45 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gaze behavior and Attentional engagement - during EEG session
Time Frame: 1 session: about 45 minutes (during EEG acquisition)
Data on participants' gaze behavior and attentional engagement during EEG recording will be obtained from the eye tracking system. Analyses will focus on eye movements, stimulus fixation duration, and saccades during video observation. Eye-tracking measures will be correlated with EEG indices and compared between groups.
1 session: about 45 minutes (during EEG acquisition)
Kinematic data - during EEG session
Time Frame: 1 session: about 45 minutes (during EEG acquisition)
Data from IMU wearable sensors will be acquired during EEG acquisition. Quantitative parameters for kinematics (i.e., position/trajectories, time, speed); dynamics (acceleration, forces); performance (jerk, accuracy, frequency and amplitude of movement) and symmetry and coordination indexes will be analyzed. These data will be correlated with EEG data and compared between groups.
1 session: about 45 minutes (during EEG acquisition)
Score of Assisting Hand Assessment (AHA)
Time Frame: 1 session: about 25-30 minutes (before or after EEG session)
The AHA is a standardized assessment tool to measure the assisting hand performance in children with UCP. It can be used for children aged between 18 months and 18 years, with playful sessions made of semi-structured activities calibrated on different ages (different board games), and lasts approximately 25-30 minutes. The videotaped assessment is subsequently scored by a certified AHA examiner.
1 session: about 25-30 minutes (before or after EEG session)
Score of the Melbourne Assessment 2 (MA-2)
Time Frame: 1 session: about 15 minutes (before or after EEG session)
The MA-2 is a valid and reliable criterion-referenced test for evaluating upper limb movement quality in children with a neurological impairment aged 2.5 to 15 years. It consists of 14 unimanually tested items including reach, pointing, manipulation, grasp, release, and pro-/supination. Only the affected hand will be tested and it lasts approximately 15 minutes.
1 session: about 15 minutes (before or after EEG session)

Collaborators and Investigators

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

Sponsor

IRCCS Fondazione Stella Maris

Investigators

  • Principal Investigator: Giuseppina Sgandurra, MD, PhD, 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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 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)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EEG_AINCP

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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