Trial Outcomes & Findings for The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop (NCT NCT01001390)
NCT ID: NCT01001390
Last Updated: 2014-03-27
Results Overview
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.
TERMINATED
NA
2 participants
Baseline
2014-03-27
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
Group 2: Without Then With AFO
Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later.
|
|---|---|---|
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Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Group 2: Without Then With AFO
Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later.
|
|---|---|---|
|
Overall Study
Failure to wear AFO device
|
2
|
0
|
Baseline Characteristics
The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop
Baseline characteristics by cohort
| Measure |
Group 1: With Then Without AFO
n=2 Participants
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.
|
|---|---|
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Age, Customized
< 6 years
|
0 participants
n=5 Participants
|
|
Age, Customized
6-18 years
|
2 participants
n=5 Participants
|
|
Age, Customized
> 18 years
|
0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One month after baseline evaluationPopulation: No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.
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.
Outcome measures
Outcome data not reported
Adverse Events
Group 1: With Then Without AFO
Group 2: Without Then With AFO
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kirsten K. Ness, PT, PhD
St. Jude Children's Research Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place