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Infant DevelopmentBAMNCT07291479

Behavioral Assessment Method Index

An observational study of Infant Development and Perinatal Stroke, run by Ohio State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

The overall goal of this study is to develop and improve assessment methods for children with and without perinatal arterial ischemic stroke (PAS)/hemiparetic cerebral palsy (HCP). Read more about this study

Who is it for?
Ages 4 to 36 monthsHealthy volunteers can take part
Conditions the study is for
Infant Development, Perinatal Stroke, Hemiparesis
What is being tested?
Non interventional study
How many people
80 participants
Where
1 siteUnited States
Study dates
7 Jul 2023to Jun 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Healthy, typically developing children, born at full-term.

Who may be able to join

  • Between 8 and 36 months old at baseline
  • Full Term Birth (37 to 41 weeks gestation)
  • Healthy development (meeting age-appropriate milestones)

Who cannot join

  • Diagnosed or suspected impairments (auditory, visual, cognitive or motor)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jill Heathcock, PhD contact

(614) 292-2397

jill.heathcock@osumc.edu

Petra Sternberg, PhD contact

614-572-5446

petra.sternberg@osumc.edu

United States1 site, 1 recruiting
  • The Ohio State University

    Columbus, Ohio, 43210

    Jill Heathcock, PhD, (614) 292-2397, jill.heathcock@osumc.edu

    Petra Sternberg, PhD, 614-572-5446, petra.sternberg@osumc.edu

    Recruiting

Other trials in United States

About this study

Official title: Development of Upper Extremity Behavioral Assessment Methods for Reach-and-grasp and Physical Rehabilitation.

The overall goal of this study is to develop and improve assessment methods for children with and without perinatal arterial ischemic stroke (PAS)/hemiparetic cerebral palsy (HCP). The focus is on behaviors of the arms and hands and includes other domains of child development like fine motor, gross motor, language, cognition, and social-emotional skills. This study involves 1) the use of data, including video recordings, from "I-ACQUIRE - Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation" (NCT03910075) and 2) a prospective longitudinal observational data collection with a typically developing cohort using a comprehensive assessment battery (play, fine motor, gross motor, language, cognition, and social emotional skills). The current study is called the BAM Index. No intervention or treatment is provided as part of the BAM Index. The I-ACQUIRE study is an RCT that includes an intervention. The BAM index study is a use of data from the I-ACQUIRE cohorts and a prospective observational study of a typically developing cohort (children without stroke or cerebral palsy) over time. The results of this work will develop, test, refine, and validate a new methodology based on reach-and-grasp and other behaviors related to child development that will have profound and lasting impact on assessment and selection of treatment strategies for pediatric physical rehabilitation of children. The use and reuse of video technology is also well-suited to remote or virtual assessment. This proposal will add to our current knowledge by 1) yielding a psychometrically robust and alternative approach to measuring upper extremity function in children with stroke and/or hemiparetic cerebral palsy and 2) defining specific parameters about how to promote closer-to-normal upper extremity function in children with motor disability.

Being tested
Non interventional study
Medical subject headings
Paresis, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non interventional studyOther

    Prospective sample is typically developing. No intervention.

Study groups in NCT07291479
Study groupRoleWhat they receive
Typically developing infantsNot described
Receives: Other: Non interventional study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Behavioral Assessment Methods (BAM)

    Calculated based on reach- and grasp parameters with a variety of object explorations.

    Measured: From enrollment to the last assessment (7 months).

Secondary outcomes (1)
  1. How the BAM index is related to fine motor, gross motor, cognition, and language skills across development for typical and atypical infants.

    Clinician and parent collected standardized measures.

    Measured: From enrollment to the last assessment (7 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start7 Jul 2023
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07291479
Sponsor's protocol ID
2021H0419
Acronym
BAM
Status last verified
Jan 2025
First submitted
5 Dec 2025
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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