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| Name | Class |
|---|---|
| University of Washington | OTHER |
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This study will investigate the effect of foot orthoses on two common conditions (ankle osteoarthritis and symptomatic adult onset flat feet) by using a custom biplane X-ray system the group has developed to very accurately and precisely quantify foot bone motion. The investigators will vary the design of the orthoses and subjects will be examined to find out which are most effective at improving function.
The aim with this proposal is to better understand how in-shoe foot orthoses achieve improvements in foot and ankle function for people with ankle osteoarthritis (OA) and/or adult acquired flatfoot resulting from posterior tibial tendon dysfunction (PTTD). The investigators also aim to be able to predict what the optimal, personalized orthotic device is for each patient is. These are common, painful, and often highly debilitating conditions, with ankle OA estimated to affect around 6% of the adult population and adult acquired flat foot around 3.3% percent of females. It has been shown that foot orthoses can be an effective conservative intervention for these conditions, and can help to postpone or negate surgery. However, for a significant proportion of patients foot orthoses are unsuccessful, and there is evidence that this may be a result of significant inter-individual variability in joint movement and loading response to the intervention. This may be due to a number of factors, including foot bone shape, muscle strength, and/or joint range of motion. In addition, the design of foot orthoses is often inconsistent between suppliers, largely because of the manual approach that is used to design and manufacture them. A further complicating factor is that prescriptions for foot orthoses are often vaguely written. Improving the investigators' understanding of different foot and ankle responses to variation in foot orthotic design is essential if the investigators are to improve how these devices function at the level of the individual patient. To measure how the individual bones of the foot move using traditional techniques is, however, very difficult. Such methods rely on skin-mounted markers that are tracked in space to determine foot and ankle kinematics. However the size and position of the foot and ankle bones means that it is not possible to measure them all of them individually. Moreover, the movement between the skin and the underlying bones, known as soft tissue artifact, introduces significant errors into the measurements. This is further complicated by the need to wear shoes for orthoses to function properly. The group has developed a biplane fluoroscopy system that is tailored to address the unique issues of measuring foot kinematics. This system has the additional advantage of being able to measure the effects of foot orthotics in unmodified shoes. To achieve the objective of understanding and being able to predict the effects of orthoses, the specific aims are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ankle OA | Experimental | inclusion criteria: 1) diagnosis of ankle OA or PTTD [non-control subjects only], 2) undergoing conservative care (i.e., prescribed a foot orthosis) and deemed not to be a surgical candidate, 3) between 18 and 80 years of age, and 4) ambulatory (able to walk at least 15 m) with the primary impediment to pain-free ambulation being ankle OA or PTTD |
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| flat foot | Experimental | inclusion criteria: 1) diagnosis of flat foot, 2) undergoing conservative care (i.e., prescribed a foot orthosis) and deemed not to be a surgical candidate, 3) between 18 and 80 years of age, and 4) ambulatory (able to walk at least 15 m) |
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| control | No Intervention | inclusion criteria: 1) between 18 and 80 years of age, and 2) ambulatory (able to walk at least 15 m) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| custom orthoses with varying degrees of hindfoot posting | Device | The base orthotic design will be altered for one foot (most symptomatic in the case of patients or randomly chosen for controls) to give variations from 5-degree lateral hindfoot posting to 10-degree medial in 2.5-degree increments. |
| Measure | Description | Time Frame |
|---|---|---|
| peak hindfoot eversion | In the proposed experiments, normal and pathological subjects will be studied while they walk with seven different designs of in-shoe orthoses in standardized footwear. Subjecting individuals to different "doses" of orthotic correction will generate "dose-response" curves (i.e., the kinematic variables) that will then be associated with patient-specific characteristics. | immediate |
| peak tibial rotation in degrees | In the proposed experiments, normal and pathological subjects will be studied while they walk with seven different designs of in-shoe orthoses in standardized footwear. Subjecting individuals to different "doses" of orthotic correction will generate "dose-response" curves (i.e., the kinematic variables) that will then be associated with patient-specific characteristics. | immediate |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for all subjects include:
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| Name | Affiliation | Role |
|---|---|---|
| William R. Ledoux, PhD | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108-1532 | United States | ||
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| ID | Term |
|---|---|
| D005413 | Flatfoot |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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|
| University of Washington |
| Seattle |
| Washington |
| 98195 |
| United States |
| D005532 |
| Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |