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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01001390
• Other study ID #: GAIT09
• Status: Terminated
• Phase: N/A
• First received: October 22, 2009
• Last updated: February 27, 2014
• Start date: October 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2014
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Research participant is diagnosed with childhood ALL and currently being treated on the TOTAL XVI protocol at St. Jude Children's Research Hospital (SJCRH)

2. Research participant is from 6 to 18 years of age at the time of the scheduled evaluation

3. Research participant has chemotherapy-induced peripheral neuropathy resulting in foot drop

4. Research participant will be receiving AFO

5. Research participant has a hemoglobin level greater than 8 g/dL and a platelet count above 50 x 109/L

Exclusion Criteria:

1. Participant has Down Syndrome or other known congenital developmental delays

2. Participant has a platelet count lower than 50 x 109/L and a hemoglobin level less than 8 g/dL

3. Participant has a lower extremity amputation, congenital deformity of the lower limb or an acute fracture of the lower limb

4. Participant has symptomatic osteonecrosis in the lower extremities

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Foot Drop
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Device:
• AFO Device
Ankle Foot Orthoses impact on net oxygen consumption.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   St. Jude Children's Research Hospital