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Behavioural Intervention

Let's Move Program for Infants with Cerebral Palsy

N/A

Recruiting

Led By Karen Harpster, PhD, OTR/L

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Caregivers fluent in English

A score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) between 3-6 months corrected age

Must not have

Living in a remote location prohibiting drives to the hospital every other week.

Infants with significant visual deficits defined by the inability to track an object horizontally

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,16 weeks, 28 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new movement intervention for infants at risk for cerebral palsy. The goal is to see if it is feasible and acceptable, as well as preliminary effective.

Who is the study for?

This trial is for English-speaking caregivers of preterm infants at risk for cerebral palsy, with severe brain abnormalities on MRI or ultrasound. Infants must be 3-8 months corrected age and have specific motor skill challenges as measured by certain assessments. Those with medical conditions preventing active participation, significant visual deficits, or living remotely from the hospital cannot join.

What is being tested?

The 'Let's Move' program is being tested in this study to see if it's feasible and acceptable for use with infants who may develop cerebral palsy. The study will also look into how effective the program might be in helping these infants improve their motor skills.

What are the potential side effects?

Since 'Let's Move' is a motor training intervention rather than a drug, traditional side effects are not expected. However, there could be fatigue or frustration during exercises which should be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My caregiver speaks English fluently.

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My baby scored 56 or less on a motor skills test at 3-6 months.

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My child is between 3 to 8 months old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I live far from the hospital, making bi-weekly visits impossible.

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My infant cannot follow an object with their eyes.

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I do not need oxygen to help me breathe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline,16 weeks, 28 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline,16 weeks, 28 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,16 weeks, 28 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up

Secondary study objectives

Change on Canadian Occupational Performance Measure before and after intervention and follow-up

Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up

Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Let's Move InterventionExperimental Treatment1 Intervention

Let's Move intervention will be administered and videotaped for 20 infant/caregiver dyads. Therapy will occur weekly (30-60 minutes per session) for 16 weeks, alternating between clinic and home (video telehealth) sessions. Each month, there will be two clinic-based sessions followed by 2 telehealth-based sessions

0 / 6Eligibility criteria met