- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01001390
The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop
February 27, 2014 updated by: St. Jude Children's Research Hospital
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
- 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.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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OTHER: Group One
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.
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Ankle Foot Orthoses impact on net oxygen consumption.
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OTHER: Group Two
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.
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Ankle Foot Orthoses impact on net oxygen consumption.
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What is the study measuring?
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.
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Improvement in Gait Efficiency While Using an AFO
Time Frame: One month after baseline evaluation
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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.
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One month after baseline evaluation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (ACTUAL)
June 1, 2011
Study Completion (ACTUAL)
June 1, 2011
Study Registration Dates
First Submitted
October 22, 2009
First Submitted That Met QC Criteria
October 23, 2009
First Posted (ESTIMATE)
October 26, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
March 27, 2014
Last Update Submitted That Met QC Criteria
February 27, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neuromuscular Diseases
- Mononeuropathies
- Peripheral Nervous System Diseases
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Peroneal Neuropathies
Other Study ID Numbers
- GAIT09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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