Joint InstabilityNCT00115401
Gait Adaptations to Passive Dynamic Ankle-Foot Orthosis Use
An observational study of Joint Instability, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Joint Instability
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2005to 17 Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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 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 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.
- Conditions
- Joint Instability
- Keywords
- Walking, Compensation, Leg Weakness, Orthotics, Joint Impairment, Healthy Volunteer, HV, Joint Inmpairment
- Medical subject headings
- Joint Instability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2005 (estimated)
- Study start16 Jun 2005
- Study completion17 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Joint InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115401
- Sponsor's protocol ID
- 050175
- Other IDs
- 05-CC-0175
- Status last verified
- 17 Oct 2007
- First submitted
- 21 Jun 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 11415746
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Adaptations to Passive Dynamic Ankle-Foot Orthosis Use
- ClinicalTrials.gov ID
- NCT00115401
- Acronym / sponsor ID
- 050175
- Conditions
- Joint Instability
- Keywords
- Walking, Compensation, Leg Weakness, Orthotics, Joint Impairment, Healthy Volunteer, HV, Joint Inmpairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 16 Jun 2005
- Study completion
- 17 Oct 2007
- First posted
- 22 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 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 design
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 11415746Holden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Instability, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00115401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.