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

This study has been completed.
Sponsor:
Information provided by:
Kessler Foundation
ClinicalTrials.gov Identifier:
NCT01336517
First received: October 2, 2009
Last updated: April 14, 2011
Last verified: April 2011
History of Changes
  Purpose

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
Hemiplegia, Spastic

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Further study details as provided by Kessler Foundation:

Enrollment: 20
Study Start Date: August 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336517

Locations
United States, New Jersey
Kessler Foundation Research Center
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
Investigators
Principal Investigator: Karen Nolan, Ph.D. Kessler Foundation
  More Information

No publications provided

Responsible Party: Karen Nolan, Ph.D., Kessler Foundation Research Center
ClinicalTrials.gov Identifier: NCT01336517     History of Changes
Other Study ID Numbers: E59007
Study First Received: October 2, 2009
Last Updated: April 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Kessler Foundation:
Stroke
Hemiplegia
AFO
Gait

Additional relevant MeSH terms:
Hemiplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013