Clinical trial NCT01001390: The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop
Official title: The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Foot Drop
Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic leukemia
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2009-10-26
Enrollment: 2
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO.
timeFrame: Baseline
Secondary outcomes:
measure: Number of Participants With Improvement in Gait Efficiency While Using an AFO
timeFrame: One month after baseline evaluation
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Kirsten K Ness, PT, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: