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

60 Participants Needed

Trial Summary

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 data supports the idea that Locomotor Training for Infants at High Risk of Cerebral Palsy is an effective treatment?

The available research shows that robotic-assisted gait training, a form of Locomotor Training, can lead to moderate to large improvements in movement skills, walking speed, and endurance for children with cerebral palsy. Although one study found no difference in walking patterns compared to traditional physical therapy, it did not evaluate overall movement skills or endurance. Additionally, robotic training may allow for longer and more varied practice sessions, which can help improve walking abilities more effectively than traditional methods. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Prone and Upright Locomotor Training, Locomotor Training, Prone Locomotor Training, Upright Locomotor Training, Robotic Locomotor Training for infants at high risk of cerebral palsy?

Research suggests that robotic gait training, which is part of the treatment, shows promise in improving mobility and motor skills in children with cerebral palsy. Studies indicate that robotic-assisted gait training can lead to moderate to large improvements in gross motor skills, gait speed, and endurance. ^{1 2 3 4 5}

What safety data exists for locomotor training in infants at high risk of cerebral palsy?

The available research does not provide specific safety data for locomotor training in infants at high risk of cerebral palsy. However, studies on related interventions, such as robotic gait training and locomotor training in children with cerebral palsy, suggest potential therapeutic benefits but do not explicitly address safety concerns. The study on infant walkers highlights potential risks, such as perpetuating primitive reflexes and contributing to adverse sequelae, but this is not directly related to locomotor training. Overall, there is a lack of specific safety data for this treatment in the target population. ^{1 2 3 6 7}

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

The available research does not provide specific safety data for locomotor training in infants at high risk of cerebral palsy, but studies on similar interventions like robotic gait training in children with cerebral palsy suggest it is generally considered safe, though individual experiences may vary. ^{1 2 3 6 7}

Is Prone and Upright Locomotor Training a promising treatment for infants at high risk of cerebral palsy?

Yes, Prone and Upright Locomotor Training is a promising treatment for infants at high risk of cerebral palsy. It can improve physical health, sleep, emotions, and daily movement activities. It also offers new ways to help infants learn to move better, which is important for their overall development. ^{1 2 3 4 8}

How is Prone and Upright Locomotor Training different from other treatments for infants at high risk of cerebral palsy?

Prone and Upright Locomotor Training is unique because it combines different forms of movement training, including robotic assistance, to help infants develop mobility skills. This approach is novel as it uses reinforcement learning and error-based movement learning, which are not typically part of standard treatments for cerebral palsy. ^{1 2 3 4 8}

What is the purpose of this trial?

The objective of this project is to characterize the evolution of locomotor learning over the first 18 months of life in infants at high risk for cerebral palsy (CP). To characterize how locomotor skill is learned (or not learned) during this critical period, the investigators will combine established protocols using robust, unbiased robotic and sensor technology to longitudinally study infant movement across three consecutive stages during the development of impaired human motor control - early spontaneous movement, prone locomotion (crawling), and upright locomotion (walking).

Research Team

Laura Prosser, PhD

Principal Investigator

Research Scientist

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Robot Reinforcement and Error-Based Movement Learning in Infants With and Without Cerebral Palsy. [2023]

2. England 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. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Locomotor and robotic assistive gait training for children with cerebral palsy. [2021]

4. Switzerland 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. [2022]

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

Robotic lower extremity exoskeleton use in a non-ambulatory child with cerebral palsy: a case study. [2023]

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

Locomotor Training in the Pediatric Spinal Cord Injury Population: A Systematic Review of the Literature. [2019]

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

Infant walkers and cerebral palsy. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Experience of Locomotor Training From the Perspectives of Therapists and Parents of Children With Cerebral Palsy. [2022]