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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,16 weeks, 28 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,571 Total Patients Enrolled

7 Trials studying Cerebral Palsy

1,820 Patients Enrolled for Cerebral Palsy

Karen Harpster, PhD, OTR/LPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

1 Previous Clinical Trials

44 Total Patients Enrolled

Media Library

Let's Move (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04886895 — N/A

Cerebral Palsy Research Study Groups: Let's Move Intervention

Cerebral Palsy Clinical Trial 2023: Let's Move Highlights & Side Effects. Trial Name: NCT04886895 — N/A

Let's Move (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04886895 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors being accepted for this experiment?

"The current enrolment criteria for this medical trial involves infants aged between 3 and 6 Months."

Answered by AI

Are there still opportunities for volunteers to participate in this research?

"According to the clinicaltrials.gov website, this trial is currently recruiting and was initially posted on July 1st 2022, with updates being applied as recently as that same date."

Answered by AI

How many participants are actively engaging in this research?

"Affirmative. Clinicaltrials.gov has information indicating that this clinical trial is currently recruiting participants, with the initial posting occurring on July 1st 2022 and a subsequent update being made to the listing on the same date. They are seeking 20 subjects from one medical facility."

Answered by AI

What are the eligibility criteria for this research trial?

"To qualify for this research, candidates must have been diagnosed with cerebral palsy and be between 3 months old and 6 months of age. The team is recruiting a total of 20 individuals in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Motor Training for Infants With Cerebral Palsy

Karen Harpster 2022. "Motor Training for Infants With Cerebral Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04886895.

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