20 Participants Needed

Let's Move Program for Infants with Cerebral Palsy

KH
NA
Overseen ByNehal A Parikh, DO, MS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital Medical Center, Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Let's Move for infants with cerebral palsy?

Research on similar treatments, like iMOVE therapy, shows that early interventions focusing on motor learning and neurorehabilitation can help improve motor skills in young children with cerebral palsy. These treatments aim to enhance mobility and postural control, which are crucial for development.12345

Is the Let's Move Program for Infants with Cerebral Palsy safe for children?

The available research does not provide specific safety data for the Let's Move Program, but similar movement-based interventions for children with cerebral palsy, like iMOVE and LEARN 2 MOVE, have been developed and tested, suggesting they are generally considered safe for young children.13467

How is the Let's Move treatment different from other treatments for infants with cerebral palsy?

The Let's Move treatment is unique because it focuses on activity-based interventions that are functional, goal-directed, and integrated into a play environment with interdisciplinary support, which is different from conventional therapies that may not emphasize these elements.13689

What is the purpose of this trial?

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.

Research Team

KH

Karen Harpster, PhD, OTR/L

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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.

Inclusion Criteria

You do not show normal fidgety movements when assessed between 3-4 months corrected age.
Babies born early with a specific type of brain abnormality seen on an MRI at term.
My baby scored 56 or less on a motor skills test at 3-6 months.
See 2 more

Exclusion Criteria

I live far from the hospital, making bi-weekly visits impossible.
My infant cannot follow an object with their eyes.
I do not need oxygen to help me breathe.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Let's Move intervention administered weekly for 16 weeks, alternating between clinic and home (video telehealth) sessions

16 weeks
8 visits (in-person), 8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Follow-up assessments at 28 weeks

Treatment Details

Interventions

  • Let's Move
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

Findings from Research

The iMOVE therapy, designed for young children with cerebral palsy (CP), aims to enhance motor learning and postural control by allowing children to self-initiate movement experiences, potentially leading to better outcomes than conventional therapy.
This study will involve 42 participants aged 1-3 years in a randomized controlled trial over 12-24 weeks, measuring gross motor function and other outcomes, which could provide valuable insights into early interventions for optimizing motor development in children with CP.
iMOVE: Intensive Mobility training with Variability and Error compared to conventional rehabilitation for young children with cerebral palsy: the protocol for a single blind randomized controlled trial.Prosser, LA., Pierce, SR., Dillingham, TR., et al.[2023]
In a study of 145 term infants, abnormal general movements observed at the 'fidgety' age (13 weeks post-term) were associated with a higher likelihood of developing cerebral palsy (CP), but the predictive accuracy was lower compared to preterm infants.
The quality of general movements did not predict limited mobility in children without CP, indicating that while general movements can be a useful indicator for CP, their effectiveness in predicting other developmental issues is limited.
Does general movements quality in term infants predict cerebral palsy and milder forms of limited mobility at 6 years?van Iersel, PA., Bakker, SC., Jonker, AJ., et al.[2017]
The Kindy Moves program is designed to improve school readiness in preschool-aged children with cerebral palsy (CP) by providing motor-based interventions in a play environment, with a focus on functional and goal-directed activities over a 4-week period.
The study will assess the feasibility of this program by measuring goal attainment and other functional outcomes in 40 children aged 2 to 5 years, using various standardized assessments before and after the intervention.
Kindy Moves: a protocol for establishing the feasibility of an activity-based intervention on goal attainment and motor capacity delivered within an interdisciplinary framework for preschool aged children with cerebral palsy.Pool, D., Elliott, C.[2023]

References

iMOVE: Intensive Mobility training with Variability and Error compared to conventional rehabilitation for young children with cerebral palsy: the protocol for a single blind randomized controlled trial. [2023]
Does general movements quality in term infants predict cerebral palsy and milder forms of limited mobility at 6 years? [2017]
Kindy Moves: a protocol for establishing the feasibility of an activity-based intervention on goal attainment and motor capacity delivered within an interdisciplinary framework for preschool aged children with cerebral palsy. [2023]
LEARN 2 MOVE 0-2 years: effects of a new intervention program in infants at very high risk for cerebral palsy; a randomized controlled trial. [2021]
Feasibility and preliminary effectiveness of a novel mobility training intervention in infants and toddlers with cerebral palsy. [2021]
Movement-based interventions for preschool-age children with, or at risk of, motor impairment: a systematic review. [2020]
Pediatric Rehabilitation Services for Children With Cerebral Palsy: What Can Existing Data Sources Tell Us? [2018]
The Use of Dynamic Weight Support with Principles of Infant Learning in a Child with Cerebral Palsy: A Case Report. [2021]
LEARN 2 MOVE 7-12 years: a randomized controlled trial on the effects of a physical activity stimulation program in children with cerebral palsy. [2021]
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