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

NCT01001390 | Terminated Results

• 1 other identifier: GAIT09
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Drop; Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Participants With Improvement in Gait Efficiency While Using an AFO

  One month after baseline evaluation

Study Arms (2)

Group One

OTHER

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

Group Two

OTHER

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

Interventions

AFO Device DEVICE

Ankle Foot Orthoses impact on net oxygen consumption.

Group One; Group Two

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Peroneal Neuropathies; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

The study was terminated due to poor accrual and poor participant compliance.

Results Point of Contact

• Title: Kirsten K. Ness, PT, PhD
• Organization: St. Jude Children's Research Hospital

info@stjude.org

866-966-5934

Study Officials

• Kirsten K Ness, PT, Ph.D

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 26, 2009
• Study Start: October 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 27, 2014
• Results First Posted: February 28, 2014

Record last verified: 2014-01

Locations

US (1)