ClinicalTrials.gg
Enrolling by invitationNCT07916519MILPCI2024Updated Nov 4, 2026

Early Detection of Cerebral Palsy Subtype

An observational study in Cerebral Palsy, Early Assessment and Early Rehabilitation Intervention, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Enrolling by invitation at 1 site in Italy. Open to participants aged 3 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
3 Months to 18 Months
Sex
All
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Study summary

Early identification of cerebral palsy (CP) has improved with the combined use of the General Movements Assessment (GMA), the Hammersmith Infant Neurological Examination (HINE) and magnetic resonance imaging (MRI). Emerging evidence indicates that the incorporation of additional instruments, may further enhance specificity and facilitate comorbidity identification. However, predicting motor subtype and functional prognosis in infancy remains difficult. The Neurofunctional Assessment (NFA) is a global tool, originally developed for preterm infants, that focuses on the development of normal functions and is based on the International Classification of Functioning, Disability and Health (ICF) approach. This study focuses on seven postural-motor manoeuvres drawn from the full NFA (squatting, balancing, supine-to-sit righting, ventral suspension, axillary suspension, lateral suspension and guided rolling), which assess three domains: axial control, distal selective motor control and lateral asymmetries.

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Conditions studied

  • Cerebral Palsy
  • Early Assessment
  • Early Rehabilitation Intervention

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Keywords

  • Cerebral Palsy
  • Motor subtype
  • functional prognosis
  • Neurofunctional assessment
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In context

Cerebral Palsy

1,898 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.

This study's planned enrollment of 30 is below the median of 63 across 469 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 233 studies on the registry; 81 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Months to 18 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

cerebral palsy or infants at neurological risk

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • premature and/or children at high neurological risk;
  • age between 0 and 3 months of corrected age;
  • Abnormal GMs and/or pathological MRI and/or abnormal HINE neurological examination;
  • signing of informed consent by parents or legal guardian.

Exclusion criteria

Exclusion Criteria:

  • congenital malformations;
  • genetic syndromes;
  • metabolic diseases;
  • absence of written consent.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • OtherNeurofunctional assessment for early identification of cerebral palsy motor subtypes and functional prognosis

    To determine whether domain-specific findings from the seven-manoeuvre NFA battery support earlier and more precise characterisation of CP motor subtype and functional prognosis.

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What researchers measure

Primary outcomes

  1. gmfm

    The Gross Motor Function Measure (GMFM-88) is a standardized observational instrument designed and validated to measure changes in gross motor function over time in children with cerebral palsy (CP)

    Time frame: every 6 months up to 2 years

  2. GMDS

    Griffiths Scales of Child Development (Third Edition, or Griffiths III) is a standardized, play-based assessment tool used to measure a child's overall development and create a detailed profile of strengths and needs from birth to 5 years and 11 months of age.

    Time frame: 2 years

Secondary outcomes

  1. gmds

    The GMDS (Griffiths Mental Development Scales) is one of the most widely used and internationally recognized standardized instruments for assessing global development in infants, toddlers, and young children. Originally designed by psychologist Ruth Griffiths, the scales are used to detect developmental delays, track clinical progress, and construct a comprehensive profile of a child's developmental strengths and difficulties.

    Time frame: at the end of the study

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Study locations

1 site
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References and documents

Publications

  • Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689. PubMed 28715518 ↗
  • Hadders-Algra M, Tacke U, Pietz J, Philippi H. Cerebral palsy: an update on its early detection. Lancet. 2026 Dec 20;406(10522):2921-2922. doi: 10.1016/S0140-6736(25)02310-4. No abstract available. PubMed 41421834 ↗
  • Peyton C, Aaby D, Barbosa VM, Boswell L, de Regnier RA, Bos AF, Sukal Moulton T. Baby Observational Selective Control AppRaisal (BabyOSCAR): Scores at 3 months predict functional ability, spastic cerebral palsy distribution, and diagnosis at 2 years. Dev Med Child Neurol. 2024 Nov;66(11):1521-1528. doi: 10.1111/dmcn.15925. Epub 2024 Apr 17. PubMed 38629475 ↗
  • Picciolini O, Gianni ML, Messina L, Pesenti N, Fumagalli M, Gardon L, Squarza C, Mosca F, Fontana C, Porro M. Development of a new scoring method in the neurofunctional assessment of preterm infants. Sci Rep. 2022 Sep 29;12(1):16335. doi: 10.1038/s41598-022-20754-y. PubMed 36175601 ↗
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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2026 to primary completion in Sep 2026, 6 months.

Of 210 non-industry observational studies under Cerebral Palsy, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 59. This study's 6 months is below that.

Counting every sponsor, half of 214 studies reached it within 20 months; a quarter within 8 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Nov 4, 2026
StartActual
Mar 10, 2026
Primary completionActual
Sep 10, 2026
CompletionEst.
Sep 10, 2028
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07916519
Responsible party
Matteo Porro (Principal Investigator, MD, pediatric PMR, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico) — Principal investigator
First posted
Nov 4, 2026
Start date
Mar 10, 2026
Primary completion
Sep 10, 2026
Completion
Sep 10, 2028 (estimated)
Last update
Nov 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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