| NCT ID | NCT07291479 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Infant Development |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-07-07 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2023-07-07 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07291479 clinical trial?
This trial is open to participants of all sexes, aged 4 Months or older, up to 36 Months, studying Infant Development. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07291479 currently recruiting?
Yes, NCT07291479 is actively recruiting participants. Contact the research team at jill.heathcock@osumc.edu for enrollment information.
Where is the NCT07291479 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT07291479 clinical trial?
NCT07291479 is sponsored by Ohio State University. The trial plans to enroll 80 participants.