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| ID | Type | Description | Link |
|---|---|---|---|
| RX002278 | Other Grant/Funding Number | Department of Veterans Affairs |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ankle osteoarthritis patients | Active Comparator | Ambulatory adult patients (18+) with ankle osteoarthritis. |
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| Healthy control subjects | Other | Ambulatory adults (18+) with no known ankle osteoarthritis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocker bottom shoe | Device | Walking shoe with a anterior posterior rocker sole. |
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| Measure | Description | Time Frame |
|---|---|---|
| Daily Step Count (# Steps) | The daily step count of a participant as measured by a body worn pedometer. | Three weeks |
| 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. |
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Inclusion Criteria:
For osteoarthritis patients:
For healthy controls:
Exclusion Criteria:
For osteoarthritis patients and healthy controls:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce J. Sangeorzan, MD | 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 | United States |
All individual participant data collected will be de-identified and placed in publically accessible online data repositories.
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Data will be posted ad-hoc on an ongoing basis.
Once posted, the data is available to the public.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2022 |
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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.
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No masking
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| Ankle foot orthosis | Device | Dynamic carbon fiber ankle brace. |
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| Standard walking shoe | Device | Standard walking shoe (control shoe) with no rocker sole. |
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| 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 |
| Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | Self reported capability of physical function Min: 0 Max: 100 A higher score indicates better physical function | 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 |
| Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | Self reported consequences of pain on relevant aspects of one's life. Min:0 Max: 100 A higher score indicates more pain interference | three weeks |
| Foot and Ankle Ability Measure (FAAM) | American Academy of Orthopaedic Surgeons Foot and Ankle Module questionnaire designed to assess foot and ankle conditions. Min:0 Max: 100 Higher= better | 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. scale of 1-10 higher= worse | three weeks |
| FG001 | Healthy Control Subjects | Ambulatory adults (18+) with no known ankle osteoarthritis. Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole. |
| FG002 | Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
| FG003 | Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
| FG004 | Ankle Osteoarthritis Patients: RB, Then C, the AFO | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
| FG005 | Ankle Osteoarthritis Patients: RB, the AFO, Then C | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ankle Osteoarthritis Patients | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe: Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis: Dynamic carbon fiber ankle brace. Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole. |
| BG001 | Healthy Control Subjects | Ambulatory adults (18+) with no known ankle osteoarthritis. Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Daily Step Count (# Steps) | The daily step count of a participant as measured by a body worn pedometer. | numbers analyzed are different as there was issue with the data collection device and data were not recorded | Posted | Mean | Standard Deviation | steps | Three weeks |
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| Secondary | Ankle Joint Range of Motion (Degrees) | Range of motion of the ankle joint in degrees as measured by biplane fluoroscopy and/ or CT scan | Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data | Posted | Three weeks |
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| Secondary | Self-selected Walking Speed | Self-selected walking speed as measured with a stop watch when walking a fixed distance. | Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data | Posted | Three weeks |
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| Secondary | Qualitative Assessment of Patient Device Wearing | Would you continue to wear the device if you were not part of the study? Why/why not? | Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data | Posted | Three weeks |
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| Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | Self reported capability of physical function Min: 0 Max: 100 A higher score indicates better physical function | numbers analyzed are different as there was issue with the data collection device and data were not recorded | Posted | Mean | Standard Deviation | score on a scale | three weeks |
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| Secondary | Fast Walking Speed | Fast walking speed as measured with a stop watch when walking a fixed distance. | Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data | Posted | Three weeks |
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| Secondary | 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. | Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data | Posted | Three weeks |
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| Secondary | Qualitative Assessment of Patient Satisfaction With the Device | Do you like the device? Why/why not? | Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data | Posted | Three weeks |
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| Secondary | Qualitative Assessment of Device Preference | Do you have a preference to one of the treatments? Which one? Why/why not? | Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data | Posted | Three Months |
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| Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | Self reported consequences of pain on relevant aspects of one's life. Min:0 Max: 100 A higher score indicates more pain interference | issue with data collection device, data were not collected for all participants | Posted | Mean | Standard Deviation | score on a scale | three weeks |
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| Secondary | Foot and Ankle Ability Measure (FAAM) | American Academy of Orthopaedic Surgeons Foot and Ankle Module questionnaire designed to assess foot and ankle conditions. Min:0 Max: 100 Higher= better | issue with data collection device, data were not collected for all participants | Posted | Mean | Standard Deviation | score on a scale | three weeks |
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| Secondary | 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. scale of 1-10 higher= worse | issue with data collection device, data were not collected for all participants | Posted | Mean | Standard Deviation | score on a scale | three weeks |
|
6 weeks
we did not expect mortality during this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ankle Foot Orthosis (AFO) | Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG001 | Healthy Control Subjects | Ambulatory adults (18+) with no known ankle osteoarthritis. Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | Rocker Bottom Shoe (RB) | Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | Control (C) | Control (C): Standard walking shoe (control shoe) with no rocker sole. | 0 | 8 | 1 | 8 | 0 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sangeorzan | VA | 206-516-3261 | bruce.sangeorzan@va.gov |
| May 22, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 22, 2022 | May 22, 2023 | ICF_001.pdf |
| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| With AFO |
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| With RB |
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| OG003 | Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
| OG004 | Ankle Osteoarthritis Patients: RB, Then C, the AFO | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
| OG005 | Ankle Osteoarthritis Patients: RB, the AFO, Then C | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
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| OG003 | Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
| OG004 | Ankle Osteoarthritis Patients: RB, Then C, the AFO | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
| OG005 | Ankle Osteoarthritis Patients: RB, the AFO, Then C | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
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| OG003 | Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
| OG004 | Ankle Osteoarthritis Patients: RB, Then C, the AFO | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
| OG005 | Ankle Osteoarthritis Patients: RB, the AFO, Then C | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
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| OG003 | Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
| OG004 | Ankle Osteoarthritis Patients: RB, Then C, the AFO | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
| OG005 | Ankle Osteoarthritis Patients: RB, the AFO, Then C | Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole. First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks) |
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