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Evaluation of the Effect of an Ankle Foot Orthoses for Ambulatory Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01336517
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : April 18, 2011
Sponsor:
Information provided by:
Kessler Foundation

Tracking Information
First Submitted Date October 2, 2009
First Posted Date April 18, 2011
Last Update Posted Date April 18, 2011
Study Start Date August 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the Effect of an Ankle Foot Orthoses for Ambulatory Function
Official Title Comprehensive Evaluations of the Effect of an Ankle Foot Orthoses for Ambulatory Function in Adults With Hemiplegia
Brief Summary The main purpose of this investigation is to evaluate the effect of a lower leg brace on walking efficiency and community walking in people who have weakness in one side of the body caused after a stroke. The evaluation will consist of several tests that will evaluate movement, tightness, balance and sensation in affected leg.
Detailed Description To comprehensively evaluate the effect of an AFO on ambulatory function and loading in hemiplegic gait. This study is addressing important questions regarding the effect of an AFO on gait and introduces technology for quantifiable objective assessment of AFO effectiveness. It will attempt to identify if AFO wear compliance increases community ambulation and walking efficiency bilaterally. Research is needed to fully understand how compliance affects mobility outcomes.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with a history of hemiplegia secondary to stroke, between the ages of 18 and 75, who are greater than 6 months post and have been prescribed a custom molded AFO for assistance with gait deviations
Condition Hemiplegia, Spastic
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April¬†14,¬†2011)
20
Original Actual Enrollment Same as current
Actual Study Completion Date December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Between the ages of 18 and 75
  • Have sustained a stroke at least 6 months prior to study enrollment
  • Use a prescribed custom brace while walking
  • Have no history of injury, orthopedic or other medical problem in the normal leg
  • Be able to walk independently or with close supervision for 25 feet without a brace or cane
  • Wear shoes sizes 5 1/2 - 11 US womens or size 6-13 US mens

Exclusion Criteria:

  • Orthopedic problems or history that will interfere with walking or limit the range of motion of legs
  • Neurological illness, history, or conditions that my interfere with walking except for stroke
  • Psychiatric conditions or history that would interfere with the ability to walk or follow directions
  • Serious lung or heart condition that could severely limit the ability to walk
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01336517
Other Study ID Numbers E59007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Karen Nolan, Ph.D., Kessler Foundation Research Center
Study Sponsor Kessler Foundation
Collaborators Not Provided
Investigators
Principal Investigator: Karen Nolan, Ph.D. Kessler Foundation
PRS Account Kessler Foundation
Verification Date April 2011