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Recruiting NCT07291479

Behavioral Assessment Method Index

Observational Infant Development Perinatal Stroke Hemiparesis Cerebral Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non interventional study.
Who it may be relevant to
Registry conditions: Infant Development, Perinatal Stroke, Hemiparesis, Cerebral Palsy. Basic parameters: 4 months — 36 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • The Ohio State University — Columbus

Identifiers

NCT: NCT07291479 · 2021H0419

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗