Impact of an Orthotic Intervention in Children With Peripheral Neuropathy
IOPN
1 other identifier
interventional
27
1 country
2
Brief Summary
This research study will investigate the effect of two orthotic (brace) devices for the ankle and foot on walking and ankle flexibility in children with cancer not involving the brain or spinal cord.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2016
CompletedFirst Submitted
Initial submission to the registry
August 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2022
CompletedFebruary 10, 2023
February 1, 2023
5.7 years
August 30, 2018
February 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Step length
Length of the step in participant's gait measured by the gaitrite analysis system
8 weeks
Secondary Outcomes (4)
Ankle range of motion
8 weeks
Ankle strength
8 weeks
Gait capacity
8 weeks
Foot posture
8 weeks
Study Arms (2)
Solid ankle foot orthotic
EXPERIMENTALThis 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.
Resting night splint
ACTIVE COMPARATORAn 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.
Interventions
Eligibility Criteria
You may qualify if:
- )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.
You may not qualify if:
- )lower extremity sarcomas; 2) central nervous system tumors; 3) an antecedent neurological, developmental, or genetic disorder; and 4)osteonecrosis (ON) 5)Less than antigravity dorsiflexion strength 6) neuroblastoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's Minnesota
Minneapolis, Minnesota, 55123, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynn Tanner, MPT
Children's Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Assessor blinded to the intervention type
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2018
First Posted
August 31, 2018
Study Start
September 20, 2016
Primary Completion
May 18, 2022
Study Completion
May 18, 2022
Last Updated
February 10, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share