Clinical Trial: Gait Adaptations to Passive Dynamic Ankle-Foot Orthosis Use

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Gait Adaptations to Passive Dynamic Ankle-Foot Orthosis Use

Brief Summary:

This study will collect information on the different ways that people walk, that is, their gait, when they use ankle braces. Patients will visit NIH on at least three and as many as nine separate occasions. A physical therapist will perform a physical examination to determine how patients move, how strong they are and what their comfortable walking speed is. Then patients will sit on a chair while a camera apparatus takes special pictures of their legs, a procedure lasting up to 2 hours. Patients will be asked to return to learn how to walk with the custom Passive Dynamic Ankle-Foot Orthosis (PD-AFO)-a unique ankle brace designed to improve walking ability by providing natural support to the lower limb.

Patients 4 and older who are in good health and able to walk repeatedly a distance of 15 meters (approximately 49 feet) independently and unsupervised may be eligible for this study.

With this training, patients may return several times to learn how to walk with the brace, but for their protection, they will not be allowed to take it or use it outside the research team's supervision. The researchers will examine the leg to ensure that the brace fits and will ask questions about it. Each training visit will require up to 1.5 hours. When patients have learned to walk with the brace, they will be asked to visit again and walk while scientific pictures are taken of their legs. During the walking test, patients will wear T-shirts and shorts. Patients' arms and legs will be wrapped with a soft, rubber-like material, to allow small plastic reflective balls to be attached. Firm material known as a shell can be attached to the rubber sleeves, with Velcro or a self-sticking bandage. The small balls may also be attached to the skin, with an adhesive. Also, there may be a test of the muscles, through the use of electromyography, or EMG

Detailed Summary:

Ankle-Foot Orthoses are a common form of ankle joint bracing prescribed for patients with impaired joint function. Passive Dynamic Ankle-Foot Orthoses (PD-AFOs) constitute a special class of ankle braces designed to enhance gait function by providing natural support to the lower limb as it progresses over the stance foot. However, a fundamental design characteristic of all PD-AFOs is that they are not capable of replicating all dynamic characteristics of the natural ankle complex. As a result, the efficient use of PD-AFOs during gait requires the wearer to develop an adapted, lower limb movement control strategy that effectively optimizes positive PD-AFO characteristics while compensating for characteristics detrimental to gait function. The long term goal of this research effort is to predict a patient's ability to adapt to PD-AFO use and to customize PD-AFO characteristics to optimize that adaptation. The purpose of this series of studies is to further refine our existing methods of constructing custom PD-AFOs and to document the movement control adaptations produced by normal and healthy strength impaired subjects in response to PD-AFO use.

The research plan is comprised of three phases: technology refinement (pilot) effort (n=5), normal subject study (n=10), and an impaired subject study (n=20). During the technology refinement phase, we will refine our existing methods for PD-AFO customization and pilot test the PD-AFO accommodation gait training methods and movement control assessment measurements. The normal and impaired subject studies will be used to document PD-AFO use under a strength substitution paradigm (normal subject study) and a strength enhancement paradigm (impaired subject study).

Subjects in all study phases will participate in each of three visit types. Initially, subjects will participate in a screen
Sponsor: National Institutes of Health Clinical Center (CC)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: June 21, 2005
Date Started: June 16, 2005
Date Completion: October 17, 2007
Last Updated: January 24, 2017
Last Verified: October 17, 2007