Locomotor Training for Infants at High Risk of Cerebral Palsy

Overseen By Laura Prosser, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Genetic conditions, Congenital abnormalities, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how infants learn to move in their first 18 months, focusing on those at high risk for cerebral palsy (CP). Researchers will use sensors and robotic tools to observe and support infants as they develop skills like crawling and walking. The trial includes specific training phases, called Prone and Upright Locomotor Training, to help infants progress in their movement abilities. Infants less than six weeks old, with a history of early brain injury linked to CP, and whose families can attend study visits, may be a good fit.

As an unphased trial, this study offers families the chance to contribute to groundbreaking research that could enhance early intervention strategies for infants at risk of CP.

Do I need to stop my baby's current medications for this trial?

The trial protocol does not specify whether you need to stop your baby's current medications. It's best to consult with the trial coordinators for specific guidance.

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 this locomotor training is safe for infants at high risk of cerebral palsy?

Research shows a lack of specific safety information for certain types of movement training in infants at high risk of cerebral palsy. However, similar studies have found this training to be generally safe. The training uses devices to assist infants in learning to crawl and walk. These methods are non-invasive, meaning they don't involve surgery or entering the body. This trial does not test a new drug but focuses on understanding infant movement development, which typically carries a lower risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to helping infants at high risk for cerebral palsy develop motor skills. Unlike traditional therapies that often focus on interventions after significant delays are evident, this study emphasizes early intervention with prone and upright locomotor training. The treatment uses innovative devices like the Self-Initiated Prone Progression Crawler (SIPPC) and dynamic weight support (DWS) to encourage natural movement patterns from a very young age. By starting early and tailoring interventions to each child's development, this approach has the potential to foster better motor outcomes and possibly reduce the severity of cerebral palsy symptoms.

What evidence suggests that this locomotor training is effective for infants at high risk of cerebral palsy?

Research has shown that special exercises, both lying down and standing up, can improve movement skills in infants at high risk for cerebral palsy (CP). In this trial, infants will engage in a prone locomotor intervention using the Self-Initiated Prone Progression Crawler (SIPPC) to enhance crawling abilities. Additionally, an upright locomotor intervention phase will use dynamic weight support (DWS) to aid infants in learning to walk. Studies indicate that these methods can lead to noticeable improvements in infant movement. Incorporating robotic-assisted training as part of this approach has also shown promise in aiding young children with CP. Early results suggest that beginning this training early might help infants learn to move more effectively. ^{1 2 3 6 7}

Who Is on the Research Team?

Laura Prosser, PhD

Principal Investigator

Research Scientist

Are You a Good Fit for This Trial?

This trial is for infants under 6 weeks old at high risk for cerebral palsy due to early brain injury. Families must commit to study visits. Infants with certain genetic conditions, normal movement assessments, or better-than-expected motor performance scores are excluded.

Inclusion Criteria

Family is able to commit to study visits

My baby is younger than 6 weeks old (adjusted age for prematurity).

I had a brain injury as a baby that could lead to cerebral palsy.

Exclusion Criteria

Babies who show normal movements at 3 months or have good motor skills at 4 months will not be included in the study because they are unlikely to have cerebral palsy.

I have a genetic condition not related to cerebral palsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 months

Monthly assessments

Early Spontaneous Movement Observation

Observation of early spontaneous leg movements measured monthly

4 months

Monthly visits

Prone Locomotor Training

Prone locomotor training using the Self-Initiated Prone Progression Crawler (SIPPC)

5 months

3 times per week

Upright Locomotor Training

Upright locomotor training with dynamic weight support (DWS)

9 months

3 times per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prone and Upright Locomotor Training

Trial Overview The study tests how babies at risk of cerebral palsy learn to move from birth up to walking age. It uses special robotic and sensor technology over three stages: early movements, crawling (prone locomotion), and walking (upright locomotion).

How Is the Trial Designed?

Group I: Locomotor Learning Experimental Treatment 1 Intervention

This study has three phases. The first phase of the study will be the observation of early spontaneous leg movements which will be measured monthly from 1-4 months of age. The prone locomotor intervention phase using the Self-Initiated Prone Progression Crawler (SIPPC) will occur from 5-9 months of post-term age, or end earlier if the child achieves the ability to crawl six feet. Treatment will occur at an intensity of 3 times per week for 15-30 minutes. Infants will use the SIPPC for the duration of each therapy session The upright locomotor intervention phase using DWS will occur from 9-18 months of age, or begin earlier if the child achieves the ability to crawl six feet before 9 months of age, and end earlier if the child achieves independent walking before 18 months of age. Treatment will occur at an intensity of 3 times per week for 30 minutes. Infants will receive dynamic weight support (DWS) for the duration of the 30-minute therapy session.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Children with cerebral palsy had mixed feelings about robotic gait training with the Lokomat, often feeling uncertain about what to expect and sometimes anxious about participating, indicating a need for better engagement strategies in rehabilitation.

Despite the potential benefits of robotic training, children did not express a strong desire to achieve 'normal' walking patterns, suggesting that rehabilitation goals should align more closely with children's personal expectations and experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is it like to walk with the help of a robot? Children's perspectives on robotic gait training technology. Phelan, SK., Gibson, BE., Wright, FV.[2018]

Intensive locomotor training was positively perceived by both therapists and parents, highlighting its benefits in improving physical health, emotional well-being, and daily ambulation for children with cerebral palsy.

Participants noted the importance of session engagement and support, suggesting that future studies should include broader outcome measures that reflect the meaningful impacts of such interventions on families, beyond just motor skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Experience of Locomotor Training From the Perspectives of Therapists and Parents of Children With Cerebral Palsy. Pool, D., Elliott, C., Willis, C., et al.[2022]

This study is a randomized controlled trial comparing robotic-assisted gait training (RAGT) to traditional physiotherapy (PT) in children with cerebral palsy, aiming to assess improvements in gross motor function and walking endurance over 16 weeks with twice-weekly sessions.

The trial will evaluate key outcomes such as gross motor functional ability and walking distance, providing valuable insights into the effectiveness of RAGT compared to standard PT, which could influence rehabilitation practices for children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial. Hilderley, AJ., Fehlings, D., Lee, GW., et al.[2022]

Locomotor training (LT) has shown positive effects in pediatric spinal cord injury (SCI) patients, including improvements in walking distance, gait speed, and independence, based on a review of six studies.

However, there is currently insufficient evidence to establish definitive clinical practice guidelines for implementing LT in this population, highlighting the need for further research in pediatric SCI rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locomotor Training in the Pediatric Spinal Cord Injury Population: A Systematic Review of the Literature. Gorski, K., Harbold, K., Haverstick, K., et al.[2019]

The use of an infant walker in a 1-year-old with spastic cerebral palsy can reinforce primitive reflexes and hinder the development of important motor skills like equilibrium and protective responses.

Prolonged use of the walker may lead to adverse physical outcomes, such as heel cord contractures and hip dislocations, which are common complications in children with spastic cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant walkers and cerebral palsy. Holm, VA., Harthun-Smith, L., Tada, WL.[2019]

In a study involving 40 children with cerebral palsy, robotic assisted gait training (RAGT) combined with locomotor training did not show significant improvements in mobility outcomes compared to locomotor training alone.

All participants completed the training without any reported adverse events, indicating that both training methods are safe for children with varying levels of mobility in cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locomotor and robotic assistive gait training for children with cerebral palsy. Pool, D., Valentine, J., Taylor, NF., et al.[2021]

A study involving 30 infants, 24 with or at risk for cerebral palsy (CP), showed that a combination of reinforcement learning (RL) and error-based learning (EBL) during prone locomotion training led to significantly more arm movements and improved trial-and-error activity compared to RL alone.

The infants using the combined RL and EBL approach demonstrated greater increases in goal-directed movements over 12 weeks, suggesting that this method may enhance movement learning and retention in infants with CP more effectively than RL alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot Reinforcement and Error-Based Movement Learning in Infants With and Without Cerebral Palsy. Kolobe, THA., Fagg, AH.[2023]

A 7-year-old girl with cerebral palsy used the Trexo Home robotic gait trainer for an average of 46 minutes per week over 3.3 days, leading to an increase in bowel movement frequency from 0.4 to 1.2 per day.

While there were no significant changes in overall postural stability or range of motion, improvements were noted in head control and knee flexor spasticity, suggesting potential benefits of robotic gait training for non-ambulatory children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic lower extremity exoskeleton use in a non-ambulatory child with cerebral palsy: a case study. Diot, CM., Thomas, RL., Raess, L., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9995839/

Locomotor learning in infants at high risk for cerebral palsy Common across all three stages is the collection of comprehensive robotic, sensor, and behavioral data about how infants at risk for CP move.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04561232

Locomotor Learning in Infants at High Risk for Cerebral Palsy Prone locomotor training using the Self-Initiated Prone Progression Crawler (SIPPC) will be delivered from 5-9 months of age. Upright locomotor training with ...

3. reporter.nih.gov reporter.nih.gov/project-details/10810707

Locomotor learning in infants at high risk for cerebral palsy Infants who remain at high risk for CP at 4 months of age, which we expect to be approximately 50% of those enrolled, will progress to novel locomotor training ...

4. withpower.com withpower.com/trial/phase-cerebral-palsy-11-2020-8d3fa

Locomotor Training for Infants at High Risk of Cerebral Palsy The available research shows that robotic-assisted gait training, a form of Locomotor Training, can lead to moderate to large improvements in movement skills, ...

5. research.chop.edu research.chop.edu/cornerstone-blog/cerebral-palsy-and-locomotor-learning-teaching-the-brain-how-to-move-the-body

Cerebral Palsy and Locomotor Learning: Teaching the ... Laura Prosser, PT, PhD, is leading the first longitudinal study of locomotor learning in infants who are at high risk for cerebral palsy.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36911033/

Locomotor learning in infants at high risk for cerebral palsy This study will develop predictive models of locomotor skill acquisition over time. We hypothesize that experiencing and correcting movement ...

7. researchgate.net researchgate.net/publication/368771537_Locomotor_learning_in_infants_at_high_risk_for_cerebral_palsy_A_study_protocol

Locomotor learning in infants at high risk for cerebral palsy Prone locomotor training will be delivered from 5 to 9 months of age, followed by upright locomotor training will be delivered from 5 to 9 ...