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Carbon Fiber Custom Dynamic Orthosis for Acute Lymphoblastic Leukemia (CDOKNEEpilot Trial)

N/A

Waitlist Available

Led By Jason M Wilken

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

CDOKNEEpilot Trial Summary

This trial will test the effect of two types of shoe inserts, medial and lateral wedges, on people with knee osteoarthritis. The study will compare how well the inserts work to relieve pain and improve function, compared to no insert at all.

Eligible Conditions

Acute Lymphoblastic Leukemia
Healthy Subjects

CDOKNEEpilot Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Four Square Step Test (4SST)

Knee Range of Motion

Modified Socket Comfort Score (Comfort)

+3 more

Secondary outcome measures

Ankle Range of Motion

Peak Ankle Moment

Peak Ankle Power

+1 more

Other outcome measures

Center of Pressure Velocity Magnitude

Center of Pressure Velocity Timing

Semi-Structured Interview

CDOKNEEpilot Trial Design

6Treatment groups

Experimental Treatment

Group I: Arm 6Experimental Treatment2 Interventions

Testing Order: NoCDO, Lateral, CDO, Medial

Group II: Arm 5Experimental Treatment2 Interventions

Testing Order: NoCDO, Lateral, Medial, CDO

Group III: Arm 4Experimental Treatment2 Interventions

Testing Order: NoCDO, Medial, Lateral, CDO

Group IV: Arm 3Experimental Treatment2 Interventions

Testing Order: NoCDO, Medial, CDO, Lateral

Group V: Arm 2Experimental Treatment2 Interventions

Testing Order: NoCDO, CDO, Medial, Lateral

Group VI: Arm 1Experimental Treatment2 Interventions

Testing Order: NoCDO, CDO, Lateral, Medial

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carbon Fiber Custom Dynamic Orthosis

2022

N/A

~20

Medial or Lateral Wedge

2022

N/A

~20

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of IowaLead Sponsor

446 Previous Clinical Trials

879,482 Total Patients Enrolled

Jason M WilkenPrincipal InvestigatorUniversity of Iowa

Frequently Asked Questions

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

For whom is this experiment best suited?

"To be considered for inclusion in this trial, applicants must have reached the age of majority and their age should fall between 18 to 45 years. This medical study will accept a maximum of 20 participants."

Answered by AI

How many participants have been enrolled in this research endeavor?

"Affirmative. According to clinicaltrials.gov, the search for suitable candidates is ongoing as of June 20th 2022. This research project, which was first launched on May 9th 2022, requires a total of twenty participants from one site alone."

Answered by AI

Does this investigation accept participants who have not yet reached retirement age?

"According to the eligibility requirements, participants must be of legal age and no older than 45 years old."

Answered by AI

Are there any slots available for volunteers in this clinical research?

"In accordance with clinicaltrials.gov, this experimental trial is currently seeking participants after first being posted on May 9th 2022 and lastly edited on June 20th 2022."

Answered by AI

What are the primary objectives of this medical experiment?

"This medical trial aims to measure the Peak Ankle Moment over a set baseline. Secondary objectives include assessing Timing of peak center of pressure velocity (percent stance) during gait., Ankle range of motion (degrees) while walking, and calculating Peak ankle power (W/kg)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Heel Wedges and Carbon Fiber Custom Dynamic Orthoses to Control Knee Biomechanics

Jason Wilken 2022. "Heel Wedges and Carbon Fiber Custom Dynamic Orthoses to Control Knee Biomechanics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05209360.