The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop|
- Primary outcome of this study will analyze the net oxygen consumption during the six minute walk test among study participants under the two walking conditions, with and without AFO. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- This study will assess whether gait efficiency while using an AFO persists after one month of use. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Group one will take a six minute walk test with AFO, 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
Ankle Foot Orthoses impact on net oxygen consumption.
Group two will take a six minute walk test without AFO, 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
Ankle Foot Orthoses and net oxygen consumption.
- 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.
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Kirsten K Ness, PT, Ph.D||St. Jude Children's Research Hospital|