Let's Move Program for Infants with Cerebral Palsy

Overseen by Karen Harpster, PhD, OTR/L

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital Medical Center, Cincinnati

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

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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. ^{1 3 6 8 9}

Research Team

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

My caregiver speaks English fluently.

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.

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.

Trial 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 (Behavioural Intervention)

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

Group I: Let's Move Intervention Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Steve Davis

Children's Hospital Medical Center, Cincinnati

Chief Executive Officer since 2021

MD

Daniel Ostlie

Children's Hospital Medical Center, Cincinnati

Chief Medical Officer

MD from University of North Dakota

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Does general movements quality in term infants predict cerebral palsy and milder forms of limited mobility at 6 years? [2017]

3. England 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. [2023]

4. England 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary effectiveness of a novel mobility training intervention in infants and toddlers with cerebral palsy. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Movement-based interventions for preschool-age children with, or at risk of, motor impairment: a systematic review. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Pediatric Rehabilitation Services for Children With Cerebral Palsy: What Can Existing Data Sources Tell Us? [2018]

8. England 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. [2021]

9. England 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. [2021]