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

This study has been terminated.
(The study closed due to poor accrual and difficulty with participant compliance.)
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01001390
First received: October 22, 2009
Last updated: February 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Foot Drop
Acute Lymphoblastic Leukemia
Device: AFO Device

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Improvement in Gait Efficiency While Using an AFO [ Time Frame: One month after baseline evaluation ] [ Designated as safety issue: No ]
    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.


Enrollment: 2
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: AFO Device
Ankle Foot Orthoses impact on net oxygen consumption.
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.
Device: AFO Device
Ankle Foot Orthoses impact on net oxygen consumption.

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.
  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001390

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Kirsten K Ness, PT, Ph.D St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01001390     History of Changes
Other Study ID Numbers: GAIT09
Study First Received: October 22, 2009
Results First Received: January 15, 2014
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Acute Lymphoblastic leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014