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Motor Training for Infants With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Let's Move

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring motor skills, occupational therapy, physical therapy

Eligibility Criteria

3 Months - 8 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age at enrollment: between 3-6 months corrected age
Caregivers fluent in English
Preterm infants with objectively defined severe diffuse white matter abnormality on MRI at term OR
High-risk infants (e.g., preterm, neonatal hypoxic-ischemic encephalopathy, perinatal stroke) with moderate-severe injury on structural MRI or cranial ultrasound (e.g., basal ganglia/thalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and/or severe intraventricular/periventricular hemorrhage) at around term-equivalent age or before Neonatal Intensive Care Unit discharge AND either:
- "Absent" fidgety movements based on the Prechtl General Movement Assessment (GMA) between 3-4 months corrected age OR
- A score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) between 3-6 months corrected age (31)

Exclusion Criteria:

Medical conditions that restrict active participation such as oxygen dependence
Infants with significant visual deficits defined by the inability to track an object horizontally
Living in a remote location prohibiting drives to the hospital every other week.

Sites / Locations

Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Let's Move Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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

Motor test

Secondary Outcome Measures

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

Parent reported test for functional performance

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

Caregivers perception of child's performance on functional goals

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

Neurological exam

Full Information

NCT ID

NCT04886895

First Posted

April 29, 2021

Last Updated

February 8, 2023

Sponsor

Children's Hospital Medical Center, Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT04886895

Brief Title

Motor Training for Infants With Cerebral Palsy

Official Title

Motor Training Intervention for Infants at High-Risk for Cerebral Palsy: Feasibility and Acceptability

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 7, 2022 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The intervention in this study, Let's Move, is a motor intervention for infants at risk for cerebral palsy. We will test the feasibility and acceptability of the intervention as well as preliminary effectiveness.

Detailed Description

The aims of this study are to test the feasibility, acceptability, and operationalize a novel motor intervention, called "Let's Move" delivered using a combined clinic and home (video telehealth) therapy model.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

motor skills, occupational therapy, physical therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single cohort

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Let's Move Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Let's Move

Intervention Description

Motor intervention

Primary Outcome Measure Information:

Title

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

Description

Motor test

Time Frame

Baseline,16 weeks, 28 weeks

Secondary Outcome Measure Information:

Title

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

Description

Parent reported test for functional performance

Time Frame

Baseline,16 weeks, 28 weeks

Title

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

Description

Caregivers perception of child's performance on functional goals

Time Frame

Baseline,16 weeks, 28 weeks

Title

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

Description

Neurological exam

Time Frame

Baseline,16 weeks, 28 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

8 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age at enrollment: between 3-8 months corrected age Caregivers fluent in English Preterm infants with objectively defined severe diffuse white matter abnormality on MRI at term OR High-risk infants (e.g., preterm, neonatal hypoxic-ischemic encephalopathy, perinatal stroke) with moderate-severe injury on structural MRI or cranial ultrasound (e.g., basal ganglia/thalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and/or severe intraventricular/periventricular hemorrhage) at around term-equivalent age or before Neonatal Intensive Care Unit discharge AND either: "Absent" fidgety movements based on the Prechtl General Movement Assessment (GMA) between 3-4 months corrected age OR A score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) between 3-6 months corrected age (31) Exclusion Criteria: Medical conditions that restrict active participation such as oxygen dependence Infants with significant visual deficits defined by the inability to track an object horizontally Living in a remote location prohibiting drives to the hospital every other week.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karen Harpster, PhD, OTR/L

Phone

513-803-3604

karen.harpster@cchmc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Nehal A Parikh, DO, MS

Phone

513-517-1044

nehal.parikh@cchmc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Harpster, PhD, OTR/L

Organizational Affiliation

Children's Hospital Medical Center, Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen L Harpster, PhD, OTR/L

Phone

513-803-3604

karen.harpster@cchmc.org

First Name & Middle Initial & Last Name & Degree

Nehal A Parikh, DO, MS

Phone

513 517-1044

nehal.parikh@cchmc.org

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Motor Training for Infants With Cerebral Palsy

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