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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. Identifier: NCT01336517
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : April 18, 2011
Information provided by:
Kessler Foundation

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.

Condition or disease
Hemiplegia, Spastic

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comprehensive Evaluations of the Effect of an Ankle Foot Orthoses for Ambulatory Function in Adults With Hemiplegia
Study Start Date : August 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01336517

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United States, New Jersey
Kessler Foundation Research Center
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
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Principal Investigator: Karen Nolan, Ph.D. Kessler Foundation
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Responsible Party: Karen Nolan, Ph.D., Kessler Foundation Research Center Identifier: NCT01336517    
Other Study ID Numbers: E59007
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: April 18, 2011
Last Verified: April 2011
Keywords provided by Kessler Foundation:
Additional relevant MeSH terms:
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Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms