Behavioral Assessment Method Index

NCT07291479 | Recruiting

• 1 other identifier: 2021H0419
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• Behavioral Assessment Methods (BAM)

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

  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.

  From enrollment to the last assessment (7 months).

Study Arms (1)

Typically developing infants

Other: Non interventional study

Interventions

Non interventional study OTHER

Prospective sample is typically developing. No intervention.

Typically developing infants

Eligibility Criteria

• Age: 4 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Healthy, typically developing children, born at full-term.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead
• Nationwide Children's Hospital: collaborator
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Paresis; Cerebral Palsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Jill Heathcock, PhD

CONTACT

(614) 292-2397; jill.heathcock@osumc.edu

Petra Sternberg, PhD

CONTACT

614-572-5446; petra.sternberg@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: July 7, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)