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Orthosis

Study group 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
Age between 8-35 years old, inclusive
Gross motor functional classification score level I, II, or III
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
32 Previous Clinical Trials
6,712 Total Patients Enrolled
5 Trials studying Cerebral Palsy
136 Patients Enrolled for Cerebral Palsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants who are being recruited for this research study?

"Indeed, as per clinicaltrials.gov information, this trial is actively seeking participants. Originally posted on March 1st, 2024, the trial was last updated on February 8th of the same year. Specifically, enrollment targets 10 patients at a single site."

Answered by AI

Are potential participants currently able to apply for enrollment in this ongoing clinical trial?

"Indeed, the details available on clinicaltrials.gov highlight that this investigation is currently seeking participants. The trial was initially listed on 3/1/2024 and last revised on 2/8/2024. It aims to enroll a total of 10 patients at a single research site."

Answered by AI

Do I meet the necessary criteria to participate in this research trial?

"Individuals aged between 8 and 35 years with a diagnosis of cerebral palsy are sought for participation in this research endeavor, which aims to enroll a total of 10 eligible candidates."

Answered by AI

Is the medical study open to individuals younger than 65 years old?

"Individuals aged between 8 and 35 years are eligible for enrollment based on the inclusion criteria of this research study."

Answered by AI
~7 spots leftby Jun 2025