Impact of an Orthotic Intervention in Children With Peripheral Neuropathy
Condition: Gait, Drop Foot; Chemotherapy-induced Peripheral Neuropathy; Acute Lymphocytic Leukemia, Pediatric; Rhabdomyosarcoma; Wilms Tumor
MeSH terms: Rhabdomyosarcoma; Wilms Tumor; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Peripheral Nervous System Diseases; Gait Disorders, Neurologic
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Solid ankle foot orthotic; Resting night splint
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each group gets one of the 2 types of orthotics.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care