The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop

Study Overview
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Brief Summary
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This study is designed to see if children with acute lymphoblastic leukemia who have developed foot drop during treatment for their leukemia consume less oxygen when walking with or without an ankle brace designed to support their foot during walking. In this study children with foot drop are asked to walk for six minutes with and without brace on their ankle. During each walk, the amount of oxygen used is measured. The child wears a face mask which is attached to a device that records how much oxygen they use. The amount of oxygen used during the walk with the brace on will be compared to the amount of oxygen used with the brace off.

Detailed Description
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This study will determine the impact of Ankle Foot Orthoses (AFO) wear on gait efficiency in children with ALL and Chemotherapy-Induced Peripheral Neuropathy (CIPN). The study hypothesizes that children with CIPN will have lower net oxygen consumption during the six minute walk test while wearing AFO as compared to their net oxygen consumption during a six minute walk test while not wearing AFO. The study will assess whether gait efficiency while using an AFO persists after one month of use. The study will hypothesize that the benefits of AFO use on gait efficiency persist after one month of wear.

Official Title
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The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop

Conditions
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Foot Drop, Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Device: AFO Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Research participant is diagnosed with childhood ALL and currently being treated on the TOTAL XVI protocol at St. Jude Children's Research Hospital (SJCRH) Research participant is from 6 to 18 years of age at the time of the scheduled evaluation Research participant has chemotherapy-induced peripheral neuropathy resulting in foot drop Research participant will be receiving AFO Research participant has a hemoglobin level greater than 8 g/dL and a platelet count above 50 x 109/L Exclusion Criteria: Participant has Down Syndrome or other known congenital developmental delays Participant has a platelet count lower than 50 x 109/L and a hemoglobin level less than 8 g/dL Participant has a lower extremity amputation, congenital deformity of the lower limb or an acute fracture of the lower limb Participant has symptomatic osteonecrosis in the lower extremities

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group One<br>Group one will take a six minute walk test with AFO device, and after a rest of fifteen minutes, they will take another six minute walk test without AFO, with similar speed to the previous test. | Device: AFO Device<br>* Ankle Foot Orthoses impact on net oxygen consumption.<br>|
| Other: Group Two<br>Group two will take a six minute walk test without AFO device, and after a rest of fifteen minutes, they will take another six minute walk test with AFO, with similar speed to the previous test. | Device: AFO Device<br>* Ankle Foot Orthoses impact on net oxygen consumption.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO. | Net oxygen consumption is calculated by the formula: [net oxygen consumption = walking oxygen consumption - sitting oxygen consumption], then adjusted by total mass in kg, including body mass, the mass of the socks, appropriate shoes, helmet, mouth piece system, and for the with AFO trials, the mass of the brace. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Improvement in Gait Efficiency While Using an AFO | The difference of net oxygen consumption between wearing AFO and without wearing AFO (difference = wearing AFO - without wearing AFO) will be compared between the baseline study and one month later by using repeated measures analysis in which the effect of time will be tested controlling for other confounding variables. | One month after baseline evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lymphoblastic leukemia