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HABIT-ILE Intervention Clinical Trial in Children with Cerebral Palsy

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Summary

The National Library of Medicine registered Clinical Trial NCT07506837 on ClinicalTrials.gov, a study examining HABIT-ILE (Hand Arm Bimanual Intensive Training Including Lower Extremity) intervention effectiveness in children aged 3-8 with cerebral palsy. The trial aims to assess mobility, bimanual hand use, and motor function outcomes. The study is actively recruiting at a single US site with an estimated enrollment of 28 participants.

What changed

ClinicalTrials.gov registered a new clinical trial (NCT07506837) titled 'Clinical trial, HABIT-ILE intervention, children, cerebral palsy.' The study evaluates the HABIT-ILE intervention—a bimanual intensive training approach combined with lower extremity work—in children ages 3-8 years with cerebral palsy (Gross Motor Function Classification System levels I-III). The randomized controlled trial will measure changes in mobility, bimanual performance, and gross motor function.

Clinical investigators conducting pediatric cerebral palsy research or those seeking to refer eligible patients should consult ClinicalTrials.gov for recruitment details. Trial sponsors subject to FDAAA 801 requirements should ensure compliance with registration and results reporting obligations under 42 CFR Part 11.

Archived snapshot

Apr 3, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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CFR references

42 CFR 11.28 42 CFR 11.48

Named provisions

HABIT-ILE Intervention Cerebral Palsy Population

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Last updated

Classification

Agency
NLM
Published
July 25th, 2023
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07506837

Who this affects

Applies to
Clinical investigators Healthcare providers
Industry sector
6211 Healthcare Providers
Activity scope
Clinical Trial Registration Clinical Trial Reporting
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Clinical Research Pediatrics

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