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NCT Number: NCT07291479

Behavioral Assessment Method Index

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.

Recruiting

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Key information

Age range

4 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Non interventional study

Other

Prospective sample is typically developing. No intervention.

Primary outcomes

  1. Behavioral Assessment Methods (BAM)

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

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

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.

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

    Clinician and parent collected standardized measures.

Study contacts

Contact information is provided by the study sponsor or research team.

Jill Heathcock, PhD

CONTACT

[email protected]

(614) 292-2397

Petra Sternberg, PhD

CONTACT

[email protected]

614-572-5446

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Nationwide Children's Hospital
  • Virginia Polytechnic Institute and State University

Registry information

Official study title

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

Acronym: BAM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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