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

Hemiplegia, Spastic Clinical Trial

Official title:

Comprehensive Evaluations of the Effect of an Ankle Foot Orthoses for Ambulatory Function in Adults With Hemiplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336517
• Other study ID #: E59007
• Status: Completed
• Phase: N/A
• First received: October 2, 2009
• Last updated: April 14, 2011
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: April 2011
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemiplegia
• Hemiplegia, Spastic

Locations

Country	Name	City	State
United States	Kessler Foundation Research Center	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States,