Behavioral Assessment Method Index (BAM)

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Hemiparesis; Infant Development; Perinatal Stroke
• Intervention / Treatment: Other: Non interventional study

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Jill Heathcock, PhD; Phone Number: (614) 292-2397; Email: jill.heathcock@osumc.edu
• Study Contact Backup: Name: Petra Sternberg, PhD; Phone Number: 614-572-5446; Email: petra.sternberg@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
      • Contact: Jill Heathcock, PhD; Phone Number: (614) 292-2397; Email: jill.heathcock@osumc.edu
      • Contact: Petra Sternberg, PhD; Phone Number: 614-572-5446; Email: petra.sternberg@osumc.edu
      • Principal Investigator: Jill Heathcock, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Typically developing infants	Other: Non interventional study; Prospective sample is typically developing. No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the last assessment (7 months).

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Virginia Polytechnic Institute and State University; Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cerebral Palsy; Paresis
• Other Study ID Numbers: 2021H0419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No