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Trial record 5 of 54 for:    Foot Drop

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

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ClinicalTrials.gov Identifier: NCT01001390
Recruitment Status : Terminated (The study closed due to poor accrual and difficulty with participant compliance.)
First Posted : October 26, 2009
Results First Posted : February 28, 2014
Last Update Posted : March 27, 2014
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Foot Drop
Acute Lymphoblastic Leukemia
Intervention Device: AFO Device
Enrollment 2

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.
Arm/Group Title Group 1: With Then Without AFO Group 2: Without Then With AFO
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 2 0
Completed 0 0
Not Completed 2 0
Reason Not Completed
Failure to wear AFO device             2             0
Arm/Group Title Group 1: With Then Without AFO
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
Two participants were enrolled, however, neither participant continued to wear their ankle foot orthoses after the initial visit.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants
< 6 years 0
6-18 years 2
> 18 years 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
1.Primary Outcome
Title Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.
Arm/Group Title Group 1: With Then Without AFO
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Improvement in Gait Efficiency While Using an AFO
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.
Arm/Group Title Group 1: With Then Without AFO
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Participants were to be monitored for possible adverse events from the time of enrollment through the six-month follow-up testing. The study terminated early, and no adverse events were experienced.
Adverse Event Reporting Description Two participants were enrolled in Group 1 (With Then Without AFO). No participants were enrolled in Group 2 (Without Then With AFO).
 
Arm/Group Title Group 1: With Then Without AFO Group 2: Without Then With AFO
Hide Arm/Group Description 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 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.
All-Cause Mortality
Group 1: With Then Without AFO Group 2: Without Then With AFO
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: With Then Without AFO Group 2: Without Then With AFO
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: With Then Without AFO Group 2: Without Then With AFO
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0 
The study was terminated due to poor accrual and poor participant compliance.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kirsten K. Ness, PT, PhD
Organization: St. Jude Children's Research Hospital
Phone: 866-966-5934
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01001390     History of Changes
Other Study ID Numbers: GAIT09
First Submitted: October 22, 2009
First Posted: October 26, 2009
Results First Submitted: January 15, 2014
Results First Posted: February 28, 2014
Last Update Posted: March 27, 2014