NCT01001390

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

1. 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). 2. 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. 3. The study will assess whether gait efficiency while using an AFO persists after one month of use. 4. The study will hypothesize that the benefits of AFO use on gait efficiency persist after one month of wear.

Conditions

• Foot Drop
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DEVICE	AFO Device	Ankle Foot Orthoses impact on net oxygen consumption.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-10-26
• Last updated: 2014-03-27
• Results posted: 2014-02-28

Locations

1 site across 1 country: United States