Status:
COMPLETED
Gait Adaptations to Passive Dynamic Ankle-Foot Orthosis Use
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Joint Instability
Eligibility:
All Genders
5+ years
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 occa...
Detailed Description
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 bra...
Eligibility Criteria
Inclusion
- ELIGIBILITY CRITERIA:
- This study will include healthy males and females who are over four years of age. The study will involve healthy volunteers having normal lower extremity strength profiles and healthy volunteers with impaired ankle joint plantarflexion strength. For this project, the term healthy is defined as a lack of systemic disease that alters ability of subjects to participate in activities of their choice. In addition, healthy means no current pathology where there is any possibility of damage to muscle, ligament, or cartilage in the lower extremity. An attempt will be made to obtain an equal distribution between males and females. In addition, participation of minorities will be strongly encouraged through the use of existing outreach programs.
- INCLUSION CRITERIA:
- 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.
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
June 16 2005
Trial Type :
OBSERVATIONAL
End Date :
October 17 2007
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00115401
Start Date
June 16 2005
End Date
October 17 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892