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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Group 1: With Then Without AFO   Group 2: Without Then With AFO
STARTED   2   0 
COMPLETED   0   0 
NOT COMPLETED   2   0 
Failure to wear AFO device                2                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Two participants were enrolled, however, neither participant continued to wear their ankle foot orthoses after the initial visit.

Reporting Groups
  Description
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.

Baseline Measures
   Group 1: With Then Without AFO 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age, Customized 
[Units: Participants]
 
< 6 years   0 
6-18 years   2 
> 18 years   0 
Gender 
[Units: Participants]
 
Female   1 
Male   1 


  Outcome Measures

1.  Primary:   Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO.   [ Time Frame: Baseline ]

2.  Secondary:   Number of Participants With Improvement in Gait Efficiency While Using an AFO   [ Time Frame: One month after baseline evaluation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated due to poor accrual and poor participant compliance.


  More Information

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
e-mail: info@stjude.org



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