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Load Modulation for Cerebral Palsy
N/A
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Typically developing with no diagnosed medical conditions that affect movement, OR with a diagnosis of bilateral cerebral palsy (including diplegia, tetraplegia, and quadriplegia) where the lower limbs are more affected than the upper limbs
Aged 5 years to 19 years
Must not have
Cognitive dysfunction that would make following directions difficult
Lower limb surgery in the past year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and each loading level; during entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at children with two-sided cerebral palsy to see how their legs are affected when they take steps.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves physical tasks rather than medication, side effects may include muscle fatigue or discomfort related to the exercise involved in the stepping tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I either have no medical conditions affecting movement or have cerebral palsy with my legs more affected than my arms.
Select...
I am between 5 and 19 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have trouble understanding or following instructions.
Select...
I had surgery on my leg or foot in the last year.
Select...
I have received botulinum toxin injections in my leg muscles within the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and each loading level; during entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and each loading level; during entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Joint biomechanics (ankle)
Joint biomechanics (hip)
Joint biomechanics (knee)
+1 moreSecondary study objectives
Muscle activations (ankle)
Muscle activations (hip)
Muscle activations (knee)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: load modulationExperimental Treatment1 Intervention
Participants will experience different body weight loading conditions - with body weight added by a weighted vest or removed using the ZeroG overhead harness.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,645 Previous Clinical Trials
958,564 Total Patients Enrolled
5 Trials studying Cerebral Palsy
590 Patients Enrolled for Cerebral Palsy
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I either have no medical conditions affecting movement or have cerebral palsy with my legs more affected than my arms.I have trouble understanding or following instructions.I am between 5 and 19 years old.I had surgery on my leg or foot in the last year.I can step up on my own, with or without help from devices.I have received botulinum toxin injections in my leg muscles within the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: load modulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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