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RecruitingNCT06807203MAMIUpdated Mar 27, 2026

Motor-voice Assessment in Infants (MAMI)

An observational study in Cerebral Palsy Infantile, Pre-Term and Motor Delay, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged Up to 10 Days. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Ohio State University · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
46
Ages
Up to 10 Days
Sex
All
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Study summary

The goal of this observational study is to discover features of normal and disordered motor-voice profiles that are biobehavioral markers of physical disability in infants.. The main questions it aims to answer are:

Identify voice factors among infants with newborn-detectable risk. Identify association between individual characteristics (Gestational age at birth, global function, motor-function) and voice factors.

Examine unique features of voice production that are present in infants with high-risk for Cerebral Palsy (CP).

Participants will be asked to upload a 3-minute videos of their child at term-age, 3.5-, and 9-months of age.

At the 3.5-month and 9-month time point parents can choose to attend an optional in-person assessment with their child.

Read the detailed description

In the first months of life, infants continually produce and modify motor behaviors and acquire new ones. They kick their legs in patterns that show temporal and spatial organization, they flap their arms in a march to midline, and gain strength against gravity with their head and trunk. Most of this happens spontaneously without specific toys or environmental modifications. Over the same time period, infant also continually use and modify their voice and acquire new vocal behaviors. Three broad categories of sound occurring in vocal communication are described in infants: cries, laughs, and protophones which are seen as the precursors to speech. Motor function and voice production are not isolated developmental processes --they are present and developing in the same baby, and, they have common ontological origins in the motor cortex. It can be argued that the earliest precursors to language, spontaneous cries and protophones, are the result of a "movement" originating in signals from the CNS that can be studied to detect health and disease in combination with physical movements. Grounded in the developmental cascades framework and developmental neuroscience this project is informed by clinical and scientific advancements in: 1) Methodology for reliably scoring of spontaneous behaviors in the first months of life that are sensitive to normal and disordered movements and predictive of neurodevelopmental disabilities including Cerebral Palsy (CP) - particularly the General Movements Assessment (GMA) and associated Motor Optimality score (MOS); 2) The ability to detect abnormal voice production in populations with neurodevelopmental disabilities using acoustic analysis. Motor function and speech production are complex processes that require precise coordination of 100s of muscles. In disease states, with damage to the CNS, poor coordination can be observed through motor and voice behaviors and specific diseases identified. Importantly, motor and voice are some of the first indicators of health after birth that occur spontaneously (e.g. crying, kicking, muscle tone). Even more importantly, motor function and voice production can be measured, non-invasively, in early infancy including the newborn period.

The overall goal is to discover features of normal and disordered motor-voice profiles that are biobehavioral markers of physical disability in infants. Disabilities are difficult to identify in this ultra-early infancy period because infants cannot speak or produce voluntary movements necessary for formal testing. Furthermore, medical testing such as MRI is expensive, not accessible everywhere, and has limited predictive value for neurodevelopmental outcomes. Laboratories have demonstrated the promise of using video and audio recordings from spontaneous and elicited behaviors to identify disordered motor or voice production from normal. Arm and leg movements, midline behaviors, writhing and fidgety movements are all implicated in neurodevelopmental outcomes and some are uniquely implicated in the identification of cerebral palsy (CP). Vocalizations (grunts, squeals, raspberries, trills, clicks), crying, protophones -- core behavioral features of voice production, are also implicated in neurodevelopmental outcomes; and some are uniquely implicated in autism, but none have been consistently evaluated in infants. Multidimensional assessment of motor function and voice production will be used at two time periods that are relevant to the earliest possible screening and detection of neurodevelopmental disorders and important for general movement assessment: term-equivalent age (writhing period), 3.5 months of corrected age (fidgety period), and 9 month of corrected age in N=46 infants with newborn-detectable risk. To fully capture the complexity of motor function and voice production in infancy, a battery of tests with emerging sensitivity will be used to measure disability during development and the sensitivity to detect both major impairments and small delays; some of these measures can be reliably tested simultaneously. Tests include: (1) General Movement Analysis (GMA); (2) the GMA-associated Motor Optimality Score (MOS); (3) Voice acoustic analysis (fundamental frequency, ratio of voiced sound, shimmer, jitter, Harmonic-to-noise ratio, frequencies of the first four formants), and number of vocalizations; (4) Bayley Scales of Infant Development (Bayley-4) for motor, cognitive, and language function; (5) Test of Infant Motor Performance (TIMP); and (6) Ages and Stages Questionnaire (ASQ).

02

Conditions studied

  • Cerebral Palsy Infantile
  • Pre-Term
  • Motor Delay
  • Neurodevelopmental Disorders
  • Autism Spectrum Disorder

Keywords

  • Digital health,
  • Motor assessment,
  • voice assessment,
  • cognition
  • neurodevelopment,
03

In context

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's planned enrollment of 46 is below the median of 63 across 472 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.

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

04

Who can participate

Ages eligible
Up to 10 Days
Sexes eligible
All
Sampling method
Probability sample

Study population

Full-term and pre-term infants

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

  • gestational age of 24 0/7 - 41 6/7,
  • admitted to the NICU,
  • medically stable by 40 weeks of gestation (including off ventilator support),
  • born to mothers 18 - 43 years old at the time of birth,
  • one parent fluent in English.

Exclusion criteria

Exclusion Criteria:

  • diagnosis of a genetic syndrome (e.g. Trisomy 21),
  • musculoskeletal deformity,
  • failed hearing screen.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
46 participants (estimated)
Patient registry
No

Groups and cohorts

  • Full-term and pre-term infants

    Observational study for motor, cognitive, language, voice impairments.

    Other: Behavioral observation

Interventions

  • OtherBehavioral observation

    Behaviors will be observed in children's natural environment. With a digital health assessment.

06

What researchers measure

Primary outcomes

  1. General Movement Assessment

    A non-invasive medical exam that evaluates an infant's spontaneous movements to identify neurological issues.

    Time frame: At term-age, 3- and 9-months corrected age.

  2. GMA-associated Motor Optimality Score

    A numerical score derived from the General Movements Assessment (GMA), a method used to evaluate an infant's spontaneous movements, where a higher score indicates more optimal motor development and a lower score may suggest potential neurological concerns.

    Time frame: At term-age, 3- and 9-months corrected age.

  3. Voice acoustic analysis and number of vocalizations

    Fundamental frequency, ratio of voiced sound, shimmer, jitter, Harmonic-to-noise ratio, frequencies of the first four formants

    Time frame: At term-age, 3- and 9-months corrected age.

Secondary outcomes

  1. Ages and Stages Questionnaire

    Screens children from birth to six years old for developmental and social-emotional progress.

    Time frame: 3- and 9-months corrected age.

  2. Bayley Scales of Infant Development

    Comprehensive assessment tool for determining developmental delays in children. Scores are given as polytomous, ranging from 0 to 2. Scoring: 2 are Mastery, 1 is emerging, and 0 means absent. Mean score of 100 (Standard Deviation=15) at the 50th percentile signifies mid-average functioning. Scores below 85 (1 Standard Deviation below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.

    Time frame: Optional at 3.5- and 9-months corrected age.

  3. Test of Infant Motor Performance

    A 42-item assessment that measures an infant's motor skills and posture.

    Time frame: Optional at 3.5- and 9-months corrected age.

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking 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

Started Oct 2025 (actual). Primary completion is estimated for Jan 2028, 27 months after the start.

Of 214 non-industry observational studies under Cerebral Palsy, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 60. This study's planned 27 months is above that.

Counting every sponsor, half of 218 studies reached it within 21 months; a quarter within 8 and three quarters within 60.

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

Registered
Jan 29, 2025
First posted
Feb 4, 2025
StartActual
Oct 22, 2025
Primary completionEst.
Jan 28, 2028
CompletionEst.
Jan 28, 2030
Last update
Mar 27, 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.
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06807203
Responsible party
Jill Heathcock (Professor, Ohio State University) — Principal investigator
First posted
Feb 4, 2025
Start date
Oct 22, 2025
Primary completion
Jan 28, 2028 (estimated)
Completion
Jan 28, 2030 (estimated)
Last update
Mar 27, 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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