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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

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

Timeline

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

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

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor
455 Previous Clinical Trials
882,115 Total Patients Enrolled
Jason M WilkenPrincipal InvestigatorUniversity of Iowa
~6 spots leftby Jul 2025
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