Impact of an Orthotic Intervention in Children With Peripheral Neuropathy (IOPN)
Gait, Drop Foot, Chemotherapy-induced Peripheral Neuropathy, Acute Lymphocytic Leukemia, Pediatric
About this trial
This is an interventional supportive care trial for Gait, Drop Foot
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 1)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
Sites / Locations
- Children's Minnesota
- St. Jude Children's Research Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Solid ankle foot orthotic
Resting night splint
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.
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.