Impact of an Orthotic Intervention in Children With Peripheral Neuropathy

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. Children undergoing treatment for cancer can suffer from decreased flexibility,
strength, balance and endurance from the cancer and from direct effects of the chemotherapy
agents. These impairments have been shown to continue years after treatment end, with adult
survivors of cancer being less physically active than their siblings. Children, whose
chemotherapy includes vincristine, can develop damage to their peripheral nervous system
affecting the strength, sensation, and flexibility in their hands and feet. This can then
lead to a change in their walking pattern and ankle flexibility and likely contributes to
decreased physical activity level and fatigue.

In our clinical practice and pilot work, we know that solid ankle orthotics can be effective
in improving gait quality and ankle flexibility. However, in other areas of the country,
researchers have published on the effectiveness of using a different type of brace, called a
resting night splint, to improve gait and ankle function. Thus, we are studying the
comparative efficacy of these two approaches.

Our published pilot study demonstrated that children with cancer were able to wear solid
ankle orthotics without an impact on their safety. This study will further the research by
comparing the effect of the solid ankle foot orthotic against a resting splint worn at night
on walking and ankle flexibility in children with cancer.

Ankle foot orthotics improve a walking pattern by positioning the foot and ankle so that the
toe can clear the floor more easily and the child can take a longer step. This decreases the
energy needed for a child to walk, allowing the ability to walk longer distances or increase
physical activity level. The AFO will also increase ankle flexibility by stretching the
muscle while walking. If the child or adolescent walks with an increased step length, they
will give a greater stretch to the calf muscles while walking. In contrast, the resting night
splint can increase ankle flexibility by providing a gentle stretch to the calf muscles while
sleeping, therefore allowing improved ankle movement when walking and a longer step length.
We will examine the impact of these orthotics on walking, ankle flexibility, ankle strength,
aerobic capacity, self-reported fatigue, as well as the ability of the children to wear the
orthotic as prescribed and the severity of the damage to the nervous system.

Children and adolescents who are found to have ankle weakness, ankle tightness, and damage to
their peripheral nervous system as a result of cancer treatment will be referred to the study
by the treating physical therapist (PT). The PT will contact the investigators and they will
invite the child or adolescent to participate in the study. Using previously established
measurements in children with cancer, we will measure walking pattern, ankle strength, ankle
flexibility, foot posture, level of physical activity, and level of fatigue prior to the
orthotic intervention. The subject will then be randomized between an 8-week AFO or RNS
intervention. The orthotic will be made with a small temperature sensor that will collect
data on wearing time of the brace. After 8 weeks of orthotic wear, we will repeat the
measurements and compare results between the two orthotic types.

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