Acute Lymphoblastic Leukemia, Foot Drop
Conditions
Keywords
Acute Lymphoblastic leukemia
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.
Interventions
DEVICEAFO Device
Ankle Foot Orthoses impact on net oxygen consumption.
Sponsors
St. Jude Children's Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO. | Baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improvement in Gait Efficiency While Using an AFO | One month after baseline evaluation | 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. |
Countries
United States
Participant flow
Recruitment details
Two participants were enrolled at St. Jude Children's Research Hospital (SJCRH) between February 2010 and January 2011. The study was terminated due to poor accrual and poor participant compliance.
Pre-assignment details
Participants had a diagnosis of acute lymphoblastic leukemia and had developed foot drop during treatment for their leukemia. Randomization was to one of two reporting groups: (1) With then without AFO, and (2) Without then with AFO.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: With Then Without AFO Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failure to wear AFO device | 2 | 0 |
Baseline characteristics
| Characteristic | Group 1: With Then Without AFO |
|---|---|
| Age, Customized > 18 years | 0 participants |
| Age, Customized 6-18 years | 2 participants |
| Age, Customized < 6 years | 0 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Baseline
Population: No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.
Secondary
Number of Participants With Improvement in Gait Efficiency While Using an AFO
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.
Time frame: One month after baseline evaluation
Population: No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.