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.
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.
United States1 site, 1 recruiting
- 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
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.
- Conditions
- Infant Development, Perinatal Stroke, Hemiparesis, Cerebral Palsy
- 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 group | Role | What they receive |
|---|---|---|
| Typically developing infants | Not described Receives: Other: Non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted18 Dec 2025
- Study start7 Jul 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital, Virginia Polytechnic Institute and State University
- Responsible party
- Principal investigator, Jill Heathcock, Ohio State University
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