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Device
Ankle Exoskeletons for Cerebral Palsy
Phase < 1
Recruiting
Research Sponsored by Northern Arizona University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Gross Motor Function Classification Level I, II, or III
Diagnosis of cerebral palsy
Must not have
Any neurological, musculoskeletal or cardiorespiratory injury, health condition (including pregnancy), or diagnosis other than cerebral palsy that would affect the ability to walk as directed for short periods of time
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of one week
Summary
"This trial aims to test the use of ankle exoskeletons to help people with cerebral palsy in everyday settings."
Who is the study for?
This trial is for individuals with cerebral palsy who can walk at least 20 minutes with or without help. They must fit into the exoskeleton device and not have knee issues while walking. Participants should be able to say yes to joining, or if non-verbal, show agreement through gestures interpreted by parents.
What is being tested?
The study is testing a wearable ankle exoskeleton against normal walking to see how it helps in daily life for those with cerebral palsy. It's a practical test of the technology outside of lab conditions.
What are the potential side effects?
While specific side effects are not listed, potential risks may include discomfort from wearing the device, skin irritation where it touches the body, and muscle fatigue due to altered walking patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk with or without walking aids or assistance.
Select...
I have been diagnosed with cerebral palsy.
Select...
I can walk for 20 minutes, with or without help.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have no health issues, besides cerebral palsy, affecting my ability to walk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of one week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of one week
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Walking speed
Secondary study objectives
Heart-rate
Perceived exertion
Step length
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Exoskeleton WalkingExperimental Treatment1 Intervention
Walking with ankle exoskeleton assistance
Group II: Normal walkingPlacebo Group1 Intervention
Walking under normal conditions (no exoskeleton)
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Who is running the clinical trial?
Northern Arizona UniversityLead Sponsor
33 Previous Clinical Trials
6,555 Total Patients Enrolled
5 Trials studying Cerebral Palsy
118 Patients Enrolled for Cerebral Palsy
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