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Orthosis

Adjustable Ankle Braces for Cerebral Palsy

Phase < 1
Waitlist Available
Research Sponsored by Northern Arizona University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 8-35 years old, inclusive
Gross motor functional classification score level I, II, or III
Must not have
Excessive knee flexion during walking caused by CP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to understand how using ankle braces with adjustable stiffness can impact the way people with cerebral palsy walk.

Who is the study for?
This trial is for individuals aged 8-35 with cerebral palsy who can walk on a treadmill and have not had surgery in the last 6 months. They should not be receiving other treatments during the study, have no other conditions affecting safety, and must typically use physician-prescribed ankle braces.
What is being tested?
The study is testing an adjustable stiffness ankle brace (DAS-AFO) to see how it changes walking performance and movement patterns in people with cerebral palsy during treadmill walking exercises.
What are the potential side effects?
While specific side effects are not listed, participants may experience discomfort or skin issues from wearing the new ankle orthosis. There could also be changes in muscle or joint strain due to altered walking mechanics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 8 and 35 years old.
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I can walk and move with some level of independence.
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I can point my toes downward at least 20 degrees.
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I have been diagnosed with cerebral palsy.
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I can walk for 6 minutes on a treadmill.
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I haven't had any surgery in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My CP causes my knees to bend too much when I walk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Metabolic cost of transport
Muscle activity
Secondary study objectives
Pictorial Children's Effort Rating Table (PCERT)
System Usability Score (SUS) questionnaire

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: Study groupExperimental Treatment1 Intervention
Participants will walk with the new AFO, their own AFOs, and no AFOs.

Find a Location

Who is running the clinical trial?

Northern Arizona UniversityLead Sponsor
33 Previous Clinical Trials
6,554 Total Patients Enrolled
5 Trials studying Cerebral Palsy
117 Patients Enrolled for Cerebral Palsy
~4 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
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