12 Clinical Trials for Various Conditions
Determine motion and morphology of the healthy ankle during simulated gait.
Ankle osteoarthritis (OA) is a painful, progressive condition that can severely limit physical activity and reduce quality of life. Rocker bottom (RB) shoes and ankle-foot orthoses (AFOs) are commonly used as non-surgical treatments for ankle OA. RB shoes have a curved sole in the toe to heel direction that may alleviate joint pain by reducing ankle range of motion (ROM). Similarly, AFOs may reduce joint motion by securing the foot and ankle within the ankle-foot orthosis (AFO) frame. This study aims to determine the ability of RB shoes and AFOs to improve mobility, by relieving pain and reducing joint ROM.
The purpose of this study was to determine the acute effects of different manual cupping therapy protocols on ankle range of motion, compared to sham treatments, in generally healthy adults with limited ankle range of motion (i.e., ankle dorsiflexion less than 40 degrees).
Measure the effect of a common used ankle manipulation on ligament length in the ankle.
A convenience sample of 20 participants, 18 years or older healthy individuals were recruited. Participants were excluded if they report being pregnant or being treated for a musculoskeletal injury. After explanation of the study and consent were obtained, each participant completed background information and the Cumberland Ankle Instability Tool (CAIT). Participants began by completing a 1 minute, 3mph walking gait assessment while unbraced, followed by a 2-minute, 6mph unbraced running assessment. Following the unbraced condition participants were randomly assigned into 1 of 4 conditions: \[1\] Active Ankle 329 Ankle Sleeve, \[2\] AS1Pro, \[3\] Eclipse 1, or \[4\] Eclipse 2. Participants placed an assigned brace on each ankle and then repeated the walking gait and running assessments. After this test the participants filled out a 10-item satisfaction questionnaire, and then were randomly assigned a second brace. The protocol was repeated until they have completed the walking, running, and satisfaction survey in all 4 brace conditions.
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.
The proposed research is an observational study designed to compare estrogen and progesterone serum levels with knee and ankle joint laxity, and muscle reaction time as a measure of neuromuscular function. Three groups of women athletes with differing estrogen and progesterone profiles (normal menstrual cycles, amenorrheic, and exogenous estrogen supplementation) and one control group (male collegiate athletes) will be used to compare differences in joint laxity and neuromuscular function. Blood levels of estrogen and progesterone will be measured at four time points across the menstrual cycle. Joint laxity and muscle reaction time will also be measured at each of these points. The investigator hypothesizes that knee and ankle joint laxity and muscle reaction time will significantly increase with increasing estrogen and progesterone levels.
The primary purpose of this research study is to determine if forces within carbon fiber custom dynamic orthoses (CDOs) can be reliability assessed using Loadpad and Loadsol force measuring sensors (Novel GMBH, St. Paul, MN). An improved understanding of the forces acting within orthoses may help to guide future orthosis related research studies, provision methods, and patient education. Study participants will consist of three groups; 1) healthy, able-bodied adult participants using generic sized CDOs, which consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that runs the length of the leg and bends to store and return energy, and a semi-rigid footplate that acts as a lever arm to bend the posterior strut, 2) individuals without peripheral neuropathy who use AFO(s) regularly, and 3) individuals with peripheral neuropathy who use AFO(s) regularly. . Group 1 participants will be asked to fasten the proximal cuff to a self-selected cuff tightness 'SSCT', as well as three different predefined force levels; 'Loose' where the proximal cuff is loosely fastened around the participants leg, 'Moderate' where the proximal cuff is fastened with moderate tightness, and 'Tight' where the proximal cuff is tightly fastened around the participants leg. Testing in the predetermined force levels (Loose, Moderate, Tight) will occur in a randomized order. Group 2 and Group 3 participants will be asked to fasten their AFO(s) to a self-selected 'SSCT' tightness. For all groups, forces acting on the leg, within the proximal cuff, will be measured using wireless Loadpad sensors and forces acting on the foot will be measured using wireless Loadsol insoles. Testing will include collection of force data as participants sit quietly, stand quietly, and walk and completion of questionnaires.
Carbon fiber custom dynamic orthoses (CDOs) consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that stores and returns energy during gait, and a carbon fiber foot plate that supports the foot and allows bending of the posterior strut. The proximal cuff is a primary interface between the patient and the CDO and may influence comfort, preference, limb mechanics and loading, and effective stiffness of the CDO. The important role of the proximal cuff has not been examined. The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and CDO mechanical characteristics.
The proposed study evaluates the effect of medial and lateral wedges and carbon fiber custom dynamic orthoses (CDOs) on lower limb forces and motion during walking. Previous work has used foam wedges of different stiffness and height placed under the heel to alter CDO alignment and alter lower limb mechanics. Medial or lateral wedges have been used by individuals with unilateral knee osteoarthritis in effort to reduce knee loading. In this study, medial and lateral wedges will be placed in participants shoes, with the tall side of the wedge placed on the medial or lateral aspect of the shoes, and participants will walk at controlled and self-selected speeds and complete physical performance measures. Participants will also walk without a CDO. The proposed study will provide evidence that can be used by physicians when treating knee osteoarthritis.
The primary purpose of this research study is to determine if the stiffness of a commercially available ankle foot orthosis (Malleo-Lok, Bio-Mechanical Composites, Des Moines IA) impacts gait biomechanics and overall joint level stiffness. Previously published research suggests that AFO stiffness can affect gait biomechanics and patient preference. However, previous studies have focused on traditional posterior strut devices with the strut aligned in the frontal plane to allow sagittal plane deflection. The Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane. The proposed study will provide insight that can be used by certified prosthetists orthotists (CPOs), physical therapists, and physicians to select the device that bests meets their patients' needs.
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. It is expected that carbon fiber braces can be designed to reduce forces in the ankle. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.