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

NCT07369167 | Not Yet Recruiting

• 1 other identifier: EEG_AINCP
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy (CP); Unilateral Cerebral Palsy; EEG; Action Observation

Keywords

Unilateral Cerebral Palsy; Mirror Neuron System; EEG; Mu rhythm; Sensorimotor; eye-tracker; wearable sensors; Action Observation; manual function; UCP

Outcome Measures

Primary Outcomes (1)

• Neurophysiological (EEG) data

  \- 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 Outcomes (4)

• Gaze behavior and Attentional engagement - during EEG session

  1 session: about 45 minutes (during EEG acquisition)

• Kinematic data - during EEG session

  1 session: about 45 minutes (during EEG acquisition)

• Score of Assisting Hand Assessment (AHA)

  1 session: about 25-30 minutes (before or after EEG session)

• Score of the Melbourne Assessment 2 (MA-2)

  1 session: about 15 minutes (before or after EEG session)

Study Arms (2)

Study Group

40 children with Unilateral Cerebral Palsy (UCP), aged 5-15 years

Control Group

40 typically developing (TD) children, aged 5-15 years

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead

Study Sites (1)

IRCCS Fondazione Stella Maris

Calambrone, Pisa, 56128, Italy

Location

Related Publications (4)

• Demas J, Bourguignon M, Perivier M, De Tiege X, Dinomais M, Van Bogaert P. Mu rhythm: State of the art with special focus on cerebral palsy. Ann Phys Rehabil Med. 2020 Oct;63(5):439-446. doi: 10.1016/j.rehab.2019.06.007. Epub 2019 Jul 9.

  PMID: 31299375 BACKGROUND

• 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

• Sgandurra G, Ferrari A, Cossu G, Guzzetta A, Fogassi L, Cioni G. Randomized trial of observation and execution of upper extremity actions versus action alone in children with unilateral cerebral palsy. Neurorehabil Neural Repair. 2013 Nov-Dec;27(9):808-15. doi: 10.1177/1545968313497101. Epub 2013 Jul 25.

  PMID: 23886886 BACKGROUND

• Sgandurra G, Biagi L, Fogassi L, Ferrari A, Sicola E, Guzzetta A, Tosetti M, Cioni G. Reorganization of action observation and sensory-motor networks after action observation therapy in children with congenital hemiplegia: A pilot study. Dev Neurobiol. 2020 Sep;80(9-10):351-360. doi: 10.1002/dneu.22783. Epub 2020 Oct 28.

  PMID: 32986904 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Giuseppina Sgandurra, MD, PhD

  IRCCS Fondazione Stella Maris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppina Sgandurra, MD, PhD

CONTACT

+39 050-886233; giuseppina.sgandurra@fsm.unipi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 27, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

IT (1)