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Solid ankle foot orthotic for Rhabdomyosarcoma (IOPN Trial)

N/A
Waitlist Available
Led By Lynn Tanner, MPT
Research Sponsored by Children's Hospitals and Clinics of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1)between 5-14 years of age; 2)demonstrated neuropathy as evidenced by a Ped-mTNS score>4; 3)normalized step length more than 1 standard deviation below mean for age26 ; 4)ankle DF PROM <10 degrees ; 5) able to give assent according to institutional guidelines; and 6) have parental consent to participate.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

IOPN Trial Summary

This study is evaluating whether a brace may help improve walking and ankle flexibility in children with cancer.

Eligible Conditions
  • Rhabdomyosarcoma
  • Wilms Tumor
  • Drop Foot
  • Peripheral Neuropathy
  • Acute Lymphocytic Leukemia

IOPN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

IOPN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Step length
Secondary outcome measures
Ankle range of motion
Ankle strength
Foot posture
+1 more

IOPN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Solid ankle foot orthoticExperimental Treatment1 Intervention
This is a leg brace that is made to fit the contour of the patient's foot, ankle, and lower leg. The two pull solid ankle AFO is fabricated from a rigid polypropylene outer boot and a more flexible silicone inner boot. It is commonly used in rehabilitation to improve gait in pediatric and adult populations. A certified orthotist fabricates the device. This device is lawfully marketed in the United States. It is not regulated by the FDA.
Group II: Resting night splintActive Control1 Intervention
An ankle resting night spring (RNS) is an off-the-shelf device that provides static sagittal plane dorsiflexion. The RNS is worn nocturnally to provide maximal stretch/length to the gastrocsoleus to maintain or increase dorsiflexion ROM and/or to prevent further regressions in ankle range. It is not regulated by the FDA.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Solid ankle foot orthotic
2016
N/A
~30

Find a Location

Who is running the clinical trial?

Children's Hospitals and Clinics of MinnesotaLead Sponsor
65 Previous Clinical Trials
5,022,212 Total Patients Enrolled
1 Trials studying Rhabdomyosarcoma
3,400 Patients Enrolled for Rhabdomyosarcoma
Pine Tree Apple Tennis Classic FoundationUNKNOWN
St. Jude Children's Research HospitalOTHER
426 Previous Clinical Trials
5,306,578 Total Patients Enrolled
14 Trials studying Rhabdomyosarcoma
4,483 Patients Enrolled for Rhabdomyosarcoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025