Immersive multisensory action observation and motor imagery for children and young adults with cerebral palsy and typical development
Immersive AOT: Multisensory Stimulation and Neurophysiological Correlates - A Pilot Study
This pilot will test whether adding sound and touch to action observation and motor imagery increases mirror-neuron system activation in children and young adults with cerebral palsy and in typically developing peers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 7 Years to 25 Years |
| Sex | All |
| Sponsor | IRCCS Fondazione Stella Maris Academic / other |
| Locations | 1 site (Calambrone, Pisa) |
| Trial ID | NCT07369193 on ClinicalTrials.gov |
What this trial studies
This observational pilot uses immersive multisensory action observation treatment (AOT) and motor imagery that combine visual, auditory, and tactile cues—potentially using haptic gloves—to stimulate the mirror neuron system. Participants include children and young adults aged 7–25 with confirmed cerebral palsy and a control group of typically developing participants, all screened for adequate cognitive functioning. Neurophysiological measures will be recorded to compare brain activation patterns during multisensory versus standard observation paradigms. The protocol is conducted in-person at IRCCS Fondazione Stella Maris and focuses on feasibility and neurophysiological correlates rather than clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are people aged 7–25 with a confirmed diagnosis of cerebral palsy and adequate verbal or nonverbal intellectual functioning (index ≥70) who can follow experimental tasks, as well as age-matched typically developing controls without intellectual disability.
Not a fit: Patients with severe sensory impairments, neuropsychiatric conditions that prevent participation, or significant intellectual disability are unlikely to participate or benefit from this protocol.
Why it matters
Potential benefit: If successful, multisensory AOT could strengthen mirror-neuron system activation and lead to more effective motor rehabilitation strategies for people with cerebral palsy.
How similar studies have performed: Previous AOT and motor imagery studies have shown benefits in cerebral palsy and audio-visual observation increases mirror-neuron activation, but fully multisensory (including tactile/haptic) AOT remains novel and less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Calambrone, Pisa
- IRCCS Fondazione Stella Maris — Calambrone, Pisa, Italy (Recruiting)
Study contacts
- Principal investigator: Giuseppina Sgandurra, PhD, MD — IRCCS Fondazione Stella Maris
- Study coordinator: Giuseppina Sgandurra, PhD, MD
- Email: gsgandurra@fsm.unipi.it
- Phone: 050/886233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.