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

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.

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Key information

Conditions

Hemiplegia, Spastic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kessler Foundation Research Center

West Orange, New Jersey, 07052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Apr 18, 2011
Registry last updated: Apr 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed