Gait Adaptations to Passive Dynamic Ankle-Foot Orthosis Use

NCT00115401 | Completed

• 2 other identifiers: 05017505-CC-0175
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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. The test involves attachment of small metal electrodes to the surface of the skin, again with an adhesive. There should not be discomfort with that test. As patients walk several times, scientific cameras will record the positions of the reflective balls. Pictures do not involve patients' faces or other parts of the body. Afterward, a unique chair system called a Biodex will measure the leg muscle strength. Patients will be asked to sit on the chair and place their leg in a foot in an apparatus, a special structure that measures strength. They will repeatedly push against the apparatus, doing so for 3 seconds. Each time patients push, the researchers will touch a small magnetic device to the skin, which will cause the muscles to push harder. Although this procedure should not cause any discomfort, it may feel unusual. If they wish, patients can ask to stop the test at any time. Few risks are involved in participating in this series of activities. There is a slight chance of mild skin irritation from the adhesives used on the skin or from the soft, rubber-like material. But the material is worn for only a brief period, and skin reactions are rare. Also, that material may feel tight, but if it causes discomfort or prevents moving, patients can ask a researcher to adjust it. There is a slight chance of skin irritation from use of the PD-AFO, but adjustment can be made to make patients comfortable. Patients may experience some muscle soreness caused by participating in the muscle strength tests. However, they will be safely monitored by a physical therapist when they try on the brace to adjust to its feel and fit, as well as during testing of gait. This study will not have a direct benefit for participants. However, participants will be paid for their time, with minimum compensation of $50.

Conditions

Joint Instability

Keywords

Walking; Compensation; Leg Weakness; Orthotics; Joint Impairment; Healthy Volunteer; HV; Joint Inmpairment

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be capable of repeatedly walking 15m independently and unsupervised. They must be co-operative and able to follow commands and have adequate natural step and stride lengths to step on three force plates in series. Subjects must have a combined lower limb size (shank and foot) that results in a PD-AFO size within the prototyping capacity (50 cm) of the selective laser sintering machine. To participate in the impaired study, subjects must have a manual muscle strength score for plantarflexion strength that is less than or equal to three out of a five point scale.

You may not qualify if:

• Subjects with an unsafe or highly variable gait pattern upon visual observation will be excluded. Subjects who are unable to repeatedly walk through the data collection volume without the use of assistive devices will be excluded. In addition, subjects with pain related to walking or impaired skin sensation (touch and pressure) will be excluded. Subjects with lower extremity muscle spasticity of 3 or greater on the Ashworth Scale will be excluded. Subjects with a history of injury, surgery, or disease affecting the function of the lower extremity will be excluded from the normal study. Subjects will be excluded from participation in the normal study if muscle strength and joint range of motion measures are outside normal limits.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Holden JP, Chou G, Stanhope SJ. Changes in knee joint function over a wide range of walking speeds. Clin Biomech (Bristol). 1997 Sep;12(6):375-382. doi: 10.1016/s0268-0033(97)00020-x.

  PMID: 11415746 BACKGROUND

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 21, 2005
• First Posted: June 22, 2005
• Study Start: June 16, 2005
• Study Completion: October 17, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-10-17

Locations

US (1)