Load Modulation for Cerebral Palsy

Overseen By Theresa S Moulton, PT, DPT, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Botulinum toxin

Disqualifiers: Lower limb surgery, Cognitive dysfunction, others

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

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to investigate lower limb impairments in children with bilateral cerebral palsy during stepping tasks.

Will I have to stop taking my current medications?

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

Is Load Modulation safe for humans?

The research on large amplitude movement therapy, which may be similar to Load Modulation, shows that children with cerebral palsy tolerated the therapy well with no adverse effects reported. ^{1 2 3 4 5}

How does the Load Modulation treatment for cerebral palsy differ from other treatments?

Load Modulation for cerebral palsy is unique because it involves using body-weight support and exoskeleton assistance to improve walking patterns. This approach focuses on reducing the load on the body and providing mechanical assistance to help patients achieve better gait and knee extension, which is different from traditional therapies that may not use such advanced technology. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Load Modulation for cerebral palsy?

The study on the Anti-Gravity Treadmill (AlterG) training, which is a form of load modulation, showed that it can reduce neuromuscular abnormalities and manage spasticity in children with cerebral palsy. This suggests that similar load modulation treatments might be effective for cerebral palsy. ^{4 11 12 13 14}

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.

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?

Group I: load modulation Experimental Treatment 1 Intervention

Participants will experience different body weight loading conditions - with body weight added by a weighted vest or removed using the ZeroG overhead harness.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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

Gait in adolescent cerebral palsy: the effect of partial unweighting. [2022]

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

Dynamic motor control is associated with treatment outcomes for children with cerebral palsy. [2022]

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

Lower limb muscle fatigue after uphill walking in children with unilateral spastic cerebral palsy. [2023]

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

Therapeutic Effects of an Anti-Gravity Treadmill (AlterG) Training on Neuromuscular Abnormalities Associated with Spasticity in Children with Cerebral Palsy. [2020]

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

The use of pressure mapping for seating posture characterisation in children with cerebral palsy. [2013]

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

Influence of different sitting positions and abduction orthoses on leg muscle activity in children with cerebral palsy. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Feasibility of using a large amplitude movement therapy to improve ambulatory function in children with cerebral palsy. [2015]

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

Effect of Adaptive Seating Systems on Postural Control and Activity Performance: A Systematic Review. [2023]

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

Are Seating Systems With a Medial Knee Support Really Helpful for Hip Displacement in Children With Spastic Cerebral Palsy GMFCS IV and V? [2019]

10. England pubmed.ncbi.nlm.nih.gov

The effects of body weight support on the locomotor pattern of spastic paretic patients. [2019]

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

Computational modeling of neuromuscular response to swing-phase robotic knee extension assistance in cerebral palsy. [2021]

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

Validating Model-Based Prediction Of Biological Knee Moment During Walking With An Exoskeleton in Crouch Gait: Potential Application for Exoskeleton Control. [2020]

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

Orthotic Body-Weight Support Through Underactuated Potential Energy Shaping with Contact Constraints. [2020]

14. Ireland pubmed.ncbi.nlm.nih.gov

Effects of limb loading on the lower-limb electromyographic activity during orthotic locomotion in a paraplegic patient. [2019]