Let's Move Program for Infants with Cerebral Palsy

Overseen By Nehal A Parikh, DO, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Oxygen dependence, Significant visual deficits, Remote location, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 36

Duration: 16 weeks

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new motor intervention called Let's Move for infants at risk for cerebral palsy. The goal is to assess the therapy's feasibility and effectiveness compared to usual care. Infants in the intervention group will attend weekly therapy sessions, both in person and via video, with exercises to perform at home. This trial may suit infants aged 3 to 8 months who have experienced certain brain injuries and exhibit specific movement challenges. As an unphased trial, it offers a unique opportunity to contribute to early-stage research that could shape future therapies for at-risk infants.

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 prior data suggests that the Let's Move program is safe for infants with cerebral palsy?

Research shows no specific safety data is available for the Let's Move program. However, this program does not use drugs or involve invasive procedures. It is a movement-based therapy designed to assist infants who might develop cerebral palsy. This therapy typically includes exercises and activities to enhance movement, which young children generally tolerate well.

Since the trial is not in a phase that typically assesses safety, the risks are considered low. Additionally, similar movement programs for infants are usually designed to be safe and supportive. Prospective participants should discuss any concerns with the study team or their child's doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Let's Move" program for infants with cerebral palsy because it offers a unique blend of personalized therapy that combines in-person sessions with telehealth options. Unlike traditional therapies that might focus solely on in-clinic visits, this program allows for flexible, home-based interventions tailored to each infant's specific goals using the Canadian Occupational Performance Measure (COPM). Caregivers are also engaged in the process, receiving home programs to reinforce progress between weekly sessions. This approach not only aims to improve motor skills more effectively but also empowers families to be active participants in their child's development.

What evidence suggests that the Let's Move program is effective for infants with cerebral palsy?

Research shows that specific motor training can help infants with cerebral palsy. This trial tests the Let's Move program as an intervention. Studies have found that programs like Let's Move, which focus on activities with clear goals, can improve motor skills. For instance, one study discovered that starting intervention early led to better movement abilities in children with cerebral palsy. The Let's Move program also actively involves caregivers, which has been shown to boost the effects of therapy. Overall, early and focused interventions are promising for improving motor development in infants at risk for cerebral palsy. ^{1 2 4 6 7}

Who Is on the Research Team?

Karen Harpster, PhD, OTR/L

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Intervention group: Let's Move Experimental Treatment 1 Intervention

Infants randomized to the Let's Move intervention group will be scheduled for therapy one time per week for 16 sessions (approximately 30-60 minutes per session). The intervention setting will involve both in-person (CCHMC clinic or in-home) and telehealth (in-home, video-based) sessions. The therapist will provide the caregivers with home programs to complete between therapy sessions (5 days per week). The home program will be based on the infant's goals set collaboratively between the caregiver and the evaluating therapist at the baseline assessment using the Canadian Occupational Performance Measure (COPM). At least half of the intervention sessions will be video recorded to assess feasibility and monitor intervention fidelity.

Group II: Control group Active Control 1 Intervention

Infants randomized to the usual care arm will receive usual care for 4 months. Therapy services provided to infants at this age vary in terms of frequency, location, and provider. Usual care is prescribed by the child's primary care provider (PCP), and in this population, usual care typically consists of one or both of the following: Early intervention therapy services provided by the state or Therapy in an outpatient clinic. Control group participants will be offered the Let's Move interventions after 16 weeks of control group.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

A 6-month physical therapy program using dynamic weight support (DWS) helped a 27-month-old girl with diplegic cerebral palsy improve her gross motor function beyond expected natural progression, with 68 therapy sessions focused on motor practice and exploration.

While gross motor skills improved, postural control showed no significant enhancement, but parents reported increased satisfaction and perceived performance in three out of four therapy goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Dynamic Weight Support with Principles of Infant Learning in a Child with Cerebral Palsy: A Case Report. Pierce, SR., Skorup, J., Alcott, M., et al.[2021]

A systematic review of 17 studies on movement-based interventions for preschool-age children with motor impairments found that these interventions did not significantly improve motor skills or outcomes related to body structure and function.

The evidence is inconclusive due to small sample sizes, varying quality of studies, and a lack of participation outcome measures, indicating a need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement-based interventions for preschool-age children with, or at risk of, motor impairment: a systematic review. Cameron, KL., Albesher, RA., McGinley, JL., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Understanding service utilization patterns and outcomes for children with cerebral palsy (CP) is crucial for effective clinical decision-making and service planning, as highlighted by a summary of fourteen data sources in the U.S.

The review suggests that existing data can inform policy and program development, and emphasizes the need for a physical therapy-specific registry to enhance data collection and improve care for individuals with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Rehabilitation Services for Children With Cerebral Palsy: What Can Existing Data Sources Tell Us? Gannotti, ME., Bailes, A., Bjornson, K., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A novel mobility training intervention for toddlers with cerebral palsy showed high feasibility and tolerability, with over 90% attendance and engagement rates among the five participants.

The intervention led to significant improvements in gross motor function, with motor development rates during treatment being up to 15 times greater than baseline, indicating its potential effectiveness for enhancing motor skills in children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary effectiveness of a novel mobility training intervention in infants and toddlers with cerebral palsy. Prosser, LA., Ohlrich, LB., Curatalo, LA., et al.[2021]

The LEARN 2 MOVE 7-12 study aims to improve physical activity in 50 children aged 7 to 12 with spastic cerebral palsy through a 6-month program combining lifestyle intervention and fitness training, highlighting the importance of regular physical activity for this population.

This study is unique as it investigates the combined effects of lifestyle changes and structured fitness training, with the expectation that these changes will lead to sustained improvements in physical activity and overall quality of life for the children involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LEARN 2 MOVE 7-12 years: a randomized controlled trial on the effects of a physical activity stimulation program in children with cerebral palsy. Van Wely, L., Becher, JG., Reinders-Messelink, HA., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 LEARN 2 MOVE 0-2 years study is a randomized controlled trial comparing the efficacy of the COPCA program to traditional infant physiotherapy in infants at very high risk for cerebral palsy, with interventions lasting one year and assessments conducted up to 21 months of age.

The primary outcome measure is the Infant Motor Profile, which will help determine the effectiveness of both interventions on motor, cognitive, and daily functioning, ultimately aiming to enhance early intervention strategies for children with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Hielkema, T., Hamer, EG., Reinders-Messelink, HA., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-cerebral-palsy-8-2021-b3608

Let's Move Program for Infants with Cerebral Palsy 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, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04886895

Motor Training for Infants With Cerebral Palsy 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38516717/

Efficacy of Early Intervention for Infants With Cerebral Palsy ... LEAP-CP lead to superior improvements in motor skills in ambulant children with CP, consistent with what is known about targeted goal-directed training.

4. mdpi.com mdpi.com/2227-9067/11/1/101

Outcomes of a Parent-Delivered Baby-mCIMT Model for ... The aim of this study is to investigate whether Baby-mCIMT (modifiedCIMT) can be as effective if parents are coached/supervised remotely.

5. ajrms.com ajrms.com/articles/Evaluation%20of%20Effectiveness%20of%20Modified%20Pediatric%20Constraint-Induced%20Movement%20Therapy%20Performed%20on%20Children%20with%20Cerebral%20Palsy%20by%20a%20Home-Treatment%20Program

Evaluation of Effectiveness of Modified Pediatric Constraint ... A series of pediatric Constraint-induced Movement Therapy (CIMT) sessions were conducted online on ten children with unilateral cerebral palsy ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10836479/

Parents' lived experience of early risk assessment for ... The aim of this study was to explore parents' lived experience of early risk assessment for CP using a mobile application for home video recording.

7. mdpi.com mdpi.com/2227-9067/12/10/1372

Feasibility, Safety, and Tolerability of Remote Ischemic ... The ancillary data assessed the feasibility, safety, and tolerability of RIC in children with unilateral CP. The study was conducted in Pediatric Assessment and ...