Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115401
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-06-21
Brief Title:
Gait Adaptations to Passive Dynamic Ankle-Foot Orthosis Use
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Gait Adaptations to Passive Dynamic Ankle-Foot Orthosis Use
Status:
COMPLETED
Status Verified Date:
2007-10-17
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 teams 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 15 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
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 teams 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 15 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
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 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 patients 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 n5 normal subject study n10 and an impaired subject study n20 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 screening and PD-AFO tuning visit that contains a neuromuscular screening examination a preferred walking speed test and measurement for a custom fitting PD-AFO Following the manufacturing of the custom PD-AFO subjects will return for their PD-AFO receipt and accommodation training visit During this visit the PD-AFO will be further customized and evaluated for comfort and performance and the subject will undergo supervised gait training in PD-AFO use Following successful accommodation to PD-AFO use subjects will return for their third visit and undergo instrumented gait analyses under three conditions targeted walking velocity without the PD-AFO self selected walking velocity with the PD-AFO and targeted walking velocity with the PD-AFO and finally objective plantarflexor strength testing
Walking velocity will be statistically compared between with and without PD-AFO conditions to determine the accommodation effect for self selected conditions and to test for differences between targeted walking conditions The magnitude of peak natural ankle plantarflexion moments will be statistically compared to determine the efficacy of the strength substitution and strength enhancement paradigms The nature and extent of movement control adaptations will be explored by contrasting the various biomechanical kinematic and kinetic variables between with and without PD-AFO conditions having congruent walking speeds Results of the neurological examination and objective strength testing will be used to rationalize the existence of different movement control adaptations between subjects and form the basis for developing an initial predictive model
The research plan is comprised of three phases technology refinement pilot effort n5 normal subject study n10 and an impaired subject study n20 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 screening and PD-AFO tuning visit that contains a neuromuscular screening examination a preferred walking speed test and measurement for a custom fitting PD-AFO Following the manufacturing of the custom PD-AFO subjects will return for their PD-AFO receipt and accommodation training visit During this visit the PD-AFO will be further customized and evaluated for comfort and performance and the subject will undergo supervised gait training in PD-AFO use Following successful accommodation to PD-AFO use subjects will return for their third visit and undergo instrumented gait analyses under three conditions targeted walking velocity without the PD-AFO self selected walking velocity with the PD-AFO and targeted walking velocity with the PD-AFO and finally objective plantarflexor strength testing
Walking velocity will be statistically compared between with and without PD-AFO conditions to determine the accommodation effect for self selected conditions and to test for differences between targeted walking conditions The magnitude of peak natural ankle plantarflexion moments will be statistically compared to determine the efficacy of the strength substitution and strength enhancement paradigms The nature and extent of movement control adaptations will be explored by contrasting the various biomechanical kinematic and kinetic variables between with and without PD-AFO conditions having congruent walking speeds Results of the neurological examination and objective strength testing will be used to rationalize the existence of different movement control adaptations between subjects and form the basis for developing an initial predictive model
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-CC-0175 | None | None | None |