Clinical trial · Interventional
Impact of an Orthotic Intervention in Children With Peripheral Neuropathy
Impact of an Orthotic Intervention on Physical Function in Children With Chemotherapy-induced Peripheral Neuropathy
NCT03655587CI-TRIAL-00063847IOPNcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia, Pediatric | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
| Gait, Drop Foot | — | UNRESOLVED | — |
| Rhabdomyosarcoma | Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
| Wilms Tumor | Wilms Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Resting night splint | Device | — | UNRESOLVED |
| Solid ankle foot orthotic | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Solid ankle foot orthotic
- description
- 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.
- interventionNames
- Device: Solid ankle foot orthotic
- type
- ACTIVE_COMPARATOR
- label
- Resting night splint
- description
- 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.
- interventionNames
- Device: Resting night splint
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 14 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.