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

St. Jude Children's Research Hospital

Status: Terminated

Conditions: Acute Lymphoblastic Leukemia; Foot Drop

Treatments: Device: AFO Device

Study type: Interventional

Funder types: Other

Identifiers

NCT01001390

GAIT09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Group One

Other group

Description:

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.

Treatment:

Device: AFO Device

Group Two

Other group

Description:

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.

Treatment:

Device: AFO Device