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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary:

  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.

Sponsor: St. Jude Children's Research Hospital

Current Primary Outcome: Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO. [ Time Frame: Baseline ]

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.


Original Primary Outcome: 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 ]

Current Secondary Outcome: Number of Participants With Improvement in Gait Efficiency While Using an AFO [ Time Frame: One month after baseline evaluation ]

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.


Original Secondary Outcome: This study will assess whether gait efficiency while using an AFO persists after one month of use. [ Time Frame: 2 years ]

Information By: St. Jude Children's Research Hospital

Dates:
Date Received: October 22, 2009
Date Started: October 2009
Date Completion:
Last Updated: February 27, 2014
Last Verified: January 2014