Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT07291479

Conditions

Infant Development

Perinatal Stroke

Hemiparesis

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Accepted

Interventions

Non interventional study

Study Details

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

Study ID

NCT07291479

Start date

Jul 7, 2023

Status verified date

Jan, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Typically developing infants

Interventions

Non interventional study

Prospective sample is typically developing. No intervention.

Primary outcome measure

  • Behavioral Assessment Methods (BAM) [ Time Frame: From enrollment to the last assessment (7 months). ]

Central Contacts and Locations

Central contacts

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Jill Heathcock, PhD

More Information

Sponsor

Ohio State University

Last update posted

Dec 18, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-12-18.