Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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The investigators' objective is to compare two non-surgical treatments (RB shoes and Toeoff brand AFOs) in OA subjects by measuring their mobility and pain during and after a multi-week trial period. The investigators will use a biplane fluoroscopy system to measure foot joint motion for each condition (RB shoe, AFO, control shoe). This will yield clinical and biomechanical measures of the effect of each orthotic on mobility, pain, and joint ROM in an ankle OA population. The investigators will also compare the clinical and biomechanics outcomes of OA subjects to those of control subjects. This information will provide evidence to support clinical decision making. Aim 1: Compare the daily sep count, self-selected walking speed, clinical outcome measures (PROMIS surveys) of a control shoe, RB shoe, and AFO worn over a multi-week trial period. Aim 2: Evaluate the effect of a control shoe, RB shoe, and AFO on the foot and ankle joints range of motion. Aim 3: Compare the ankle OA clinical and biomechanical outcome measures for the control shoe, RB shoe, and AFO to a healthy control group wearing control shoes. The efficacy of conservative treatments such as RB shoes and AFOs for managing OA pain and discomfort is not well supported by clinical evidence. By using biplane fluoroscopy along with validated clinical measures of pain and mobility, this study will elucidate the mechanism by which RB shoes and AFOs biomechanically alter foot and ankle function. Identifying beneficial treatment strategies for people with ankle OA will help them regain their mobility and improve their quality of life.

Official Title
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Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients?

Conditions
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Ankle Osteoarthritis, Healthy Ankles

Intervention / Treatment
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* Device: Rocker bottom shoe
* Device: Ankle foot orthosis
* Device: Standard walking shoe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For osteoarthritis patients: radiographic evidence of tibiotalar osteoarthritis ambulatory For healthy controls: ambulatory aged 18 or older Exclusion Criteria: For osteoarthritis patients and healthy controls: subtalar joint arthritis plans for surgical treatment of ankle osteoarthritis within the next 4 months surgical, neurological, metabolic, or lower limb musculoskeletal problem that would impair study measures inability to walk unassisted during short, repeated walking trials rheumatoid arthritis inadequate cognitive or language function to consent or to participate no phone number or stable mailing address

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The osteoarthritis participants will wear the control shoe, rocker bottom shoe, and AFO for multiple weeks each. The order of the treatments (control shoe, rocker bottom shoe, and AFO) will be randomize. The control group will only wear the control shoe.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ankle osteoarthritis patients<br>Ambulatory adult patients (18+) with ankle osteoarthritis. | Device: Rocker bottom shoe<br>* Walking shoe with a anterior posterior rocker sole.<br>Device: Ankle foot orthosis<br>* Dynamic carbon fiber ankle brace.<br>Device: Standard walking shoe<br>* Standard walking shoe (control shoe) with no rocker sole.<br>|
| Other: Healthy control subjects<br>Ambulatory adults (18+) with no known ankle osteoarthritis. | Device: Standard walking shoe<br>* Standard walking shoe (control shoe) with no rocker sole.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily step count (# steps) | The daily step count of a participant as measured by a body worn pedometer. | Three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle joint range of motion (degrees) | Range of motion of the ankle joint in degrees as measured by biplane fluoroscopy and/ or CT scan | Three weeks | 
| Self-selected walking speed | Self-selected walking speed as measured with a stop watch when walking a fixed distance. | Three weeks | 
| Qualitative assessment of patient device wearing | Would you continue to wear the device if you were not part of the study? Why/why not? | Three weeks | 
| PROMIS physical function | Self reported capability of physical function | three weeks | 
| PROMIS pain interference | Self reported consequences of pain on relevant aspects of one's life. | Three weeks | 
| Foot and ankle Mobility measure FAAM | American Academy of Orthopaedic Surgeons Foot and Ankle Module questionnaire designed to assess foot and ankle conditions. | Three weeks | 
| Numeric Pain Rating Scale | The Numeric Pain Rating Scale is a measure of pain intensity in adults in which the respondent selects a whole number (0-10) that best reflects the intensity of her / his pain. The scale will be administered verbally. | Three weeks | 
| Fast walking speed | Fast walking speed as measured with a stop watch when walking a fixed distance. | Three weeks | 
| Timed-up-and-go | Self-selected walking speed get out of a chair, walk to a line, turn around, walk back to the chair and sit down as measured with a stop watch. | Three weeks | 
| Qualitative assessment of patient satisfaction with the device | Do you like the device? Why/why not? | Three weeks | 
| Qualitative assessment of device preference | Do you have a preference to one of the treatments? Which one? Why/why not? | Three Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle-foot orthosis, Ankle osteoarthritis, Rocker bottom shoe