Load Modulation for Cerebral Palsy

TS
Overseen ByTheresa S Moulton, PT, DPT, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how children with cerebral palsy move their legs during stepping tasks. The researchers are testing whether altering body weight affects movement. Children aged 5 to 19 with bilateral cerebral palsy, where the legs are more affected than the arms, and who can step up independently, may be suitable candidates. Participants will either wear a weighted vest or use a special harness to adjust their body weight, a process known as Load Modulation. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding movement in cerebral palsy, potentially enhancing future therapies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that load modulation is safe for children with cerebral palsy?

Research shows that adjusting body weight with a vest or harness is under study to help children with cerebral palsy walk better. Past studies have tested this method with weight changes up to 15% of a child's body weight, and no major safety issues have emerged.

For instance, some research demonstrated that adding 1 to 3 kilograms of weight to a vest is safe for children with cerebral palsy. This method improves their walking without causing harm. While researchers continue to study this treatment, its use in clinical trials indicates it is considered safe enough for testing with participants.12345

Why are researchers excited about this trial?

Researchers are excited about load modulation for cerebral palsy because it offers a novel approach to therapy. Unlike traditional treatments that often involve medication or physical therapy to improve motor function, load modulation uses a weighted vest or an overhead harness to adjust body weight. This technique enables participants to experience varying weight conditions, which could lead to better movement control and muscle strength. By directly manipulating body load, researchers hope to uncover new insights into motor function improvement and potentially develop more effective rehabilitation strategies for cerebral palsy.

What evidence suggests that load modulation is effective for cerebral palsy?

This trial will explore load modulation as a treatment for cerebral palsy, where participants will experience different body weight loading conditions. Research has shown that altering the weight or resistance experienced by children with cerebral palsy can be beneficial. In one study, children adjusted to varying levels of resistance, which helped them take longer steps once the resistance was removed, indicating improved movement ability. Another study found that using tools like weighted vests or harnesses to change body weight during activities affected the movement of their hips, knees, and ankles. These findings suggest that adjusting weight or resistance might enhance walking and mobility.25678

Are You a Good Fit for This Trial?

This trial is for children and teenagers aged 5 to 19 who can step up independently, with or without help from devices. It's specifically for those with bilateral cerebral palsy where legs are more affected than arms, but also includes typically developing individuals without movement-affecting conditions.

Inclusion Criteria

I either have no medical conditions affecting movement or have cerebral palsy with my legs more affected than my arms.
I am between 5 and 19 years old.
I can step up on my own, with or without help from devices.

Exclusion Criteria

I have trouble understanding or following instructions.
Comorbidities that would make participation unsafe.
I had surgery on my leg or foot in the last year.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessment of muscle activations and joint biomechanics during stepping tasks

1 week
1 visit (in-person)

Stepping Task

Participants perform multiple step-ups and step-downs on a raised platform under different loading conditions

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for any changes in muscle activations and joint biomechanics post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Load Modulation
Trial Overview The study is exploring how load modulation affects stepping tasks in participants with bilateral cerebral palsy. Researchers want to understand the lower limb impairments during these activities.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: load modulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Published Research Related to This Trial

In a study of 76 children with cerebral palsy, those using seating systems with medial knee support (MKS) experienced a significant increase in hip displacement, as measured by the Reimer's migration index, from 26.89% to 44.18%.
The rate of hip displacement progression was notably higher in the MKS group at 14.72% per year compared to 7.82% per year in the control group, suggesting that MKS may worsen hip displacement in these children.
Are Seating Systems With a Medial Knee Support Really Helpful for Hip Displacement in Children With Spastic Cerebral Palsy GMFCS IV and V?Kim, IS., Park, D., Ko, JY., et al.[2019]

Citations

Load Modulation for Cerebral Palsy · Info for ParticipantsIn a study of 76 children with cerebral palsy, those using seating systems with medial knee support (MKS) experienced a significant increase in hip displacement ...
Safety and effectiveness of non-invasive brain stimulation on ...The meta-analysis examining the effects of NIBS on CP revealed significant improvements in mobility ability, measured by the GMFM-E and 6MWT.
Effects of Therapeutic Exercise Intensity on Cerebral Palsy ...In this study, we assessed the effects of intensive exercise-based therapy on improvement in gross motor function in children with CP.
Gradual increase of perturbation load induces a longer ...We observed that children with CP adapted to the resistance force perturbation and showed an aftereffect consisting of increased step length after load release.
(PDF) Load Modulation Affects Pediatric Lower Limb Joint ...The purpose of this study was to investigate the effect of load modulation from −20% to +15% of body weight on typical pediatric lower limb ...
Load Modulation Affects Pediatric Lower Limb Joint ...The purpose of this study was to investigate the effect of load modulation from −20% to +15% of body weight on typical pediatric lower limb joint moments ...
Load modulation affects pediatric lower limb joint moments ...improves the regularity of the stepping kinematics in children with cerebral palsy. 463. Dev. Neurorehabil. 14, 87–93. https://doi.org/10.3109/ ...
Lifelong Fitness in Ambulatory Children and Adolescents ...Some studies have had participants add a weighted vest for added loading, with weights between 1 and 3 kg. ... CP at a sufficient but safe ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security