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

Completed

• Conditions: Hemiplegia, Spastic

• Registration Number: NCT01336517
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-08
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2009-10-02
• Status Verified: 2011-04
• Study First Submitted QC: 2011-04-14
• Last Update Submitted: 2011-04-14
• Study First Posted: 2011-04-18
• Last Update Posted: 2011-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Kessler Foundation Research Center; 🇺🇸 West Orange, New Jersey, United States