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

Sponsor
Kessler Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT01336517
Collaborator
(none)
20
Enrollment
1
Location
16
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Aug 1, 2007
    Actual Primary Completion Date :
    Dec 1, 2008
    Actual Study Completion Date :
    Dec 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 75 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01336517
      Other Study ID Numbers:
      • E59007
      First Posted:
      Apr 18, 2011
      Last Update Posted:
      Apr 18, 2011
      Last Verified:
      Apr 1, 2011
      Keywords provided by , ,
      Stroke
      Hemiplegia
      AFO
      Gait
      Additional relevant MeSH terms:
      Hemiplegia

      Study Results

      No Results Posted as of Apr 18, 2011