Behavioral Assessment Method Index

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07291479
Status
Recruiting
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Conditions

  • Cerebral Palsy
  • Hemiparesis
  • Infant Development
  • Perinatal Stroke

Eligibility Criteria

Sex
ALL
Age
4 Months - 36 Months
Healthy Volunteers
Accepted

Interventions

  • Non interventional study — OTHER
    Prospective sample is typically developing. No intervention.

Study Details

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.

Key Dates

Start date
Jul 7, 2023
Status verified
Jan 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Typically developing infants

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State UniversityColumbusOhio43210
Jill Heathcock, PhD
[email protected]
(614) 292-2397
Petra Sternberg, PhD
[email protected]
614-572-5446
Jill Heathcock, PhD (PRINCIPAL_INVESTIGATOR)

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