Ankle Osteoarthritis, Healthy Ankles
Conditions
Keywords
Rocker bottom shoe, Ankle-foot orthosis, Ankle osteoarthritis
Brief summary
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
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.
Interventions
DEVICERocker bottom shoe
Walking shoe with a anterior posterior rocker sole.
DEVICEAnkle foot orthosis
Dynamic carbon fiber ankle brace.
DEVICEStandard walking shoe
Standard walking shoe (control shoe) with no rocker sole.
Sponsors
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Step Count (# Steps) | Three weeks | The daily step count of a participant as measured by a body worn pedometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-selected Walking Speed | Three weeks | Self-selected walking speed as measured with a stop watch when walking a fixed distance. |
| Qualitative Assessment of Patient Device Wearing | Three weeks | Would you continue to wear the device if you were not part of the study? Why/why not? |
| Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | three weeks | Self reported capability of physical function Min: 0 Max: 100 A higher score indicates better physical function |
| Fast Walking Speed | Three weeks | Fast walking speed as measured with a stop watch when walking a fixed distance. |
| Timed-up-and-go | Three weeks | 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. |
| Ankle Joint Range of Motion (Degrees) | Three weeks | Range of motion of the ankle joint in degrees as measured by biplane fluoroscopy and/ or CT scan |
| Qualitative Assessment of Device Preference | Three Months | Do you have a preference to one of the treatments? Which one? Why/why not? |
| Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | three weeks | Self reported consequences of pain on relevant aspects of one's life. Min:0 Max: 100 A higher score indicates more pain interference |
| Foot and Ankle Ability Measure (FAAM) | three weeks | American Academy of Orthopaedic Surgeons Foot and Ankle Module questionnaire designed to assess foot and ankle conditions. Min:0 Max: 100 Higher= better |
| Numeric Pain Rating Scale | three weeks | 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 |
| Qualitative Assessment of Patient Satisfaction With the Device | Three weeks | Do you like the device? Why/why not? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Healthy Control Subjects Ambulatory adults (18+) with no known ankle osteoarthritis.
Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole. | 1 |
| Total | 11 |
Baseline characteristics
| Characteristic | Healthy Control Subjects | Total | Ankle Osteoarthritis Patients |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 7 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 3 Participants |
| Age, Continuous | 62 years | 65 years | 66 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 11 Participants | 10 Participants |
| Region of Enrollment United States | 1 Participants | 11 Participants | 10 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 9 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 1 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 1 | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 1 | 0 / 8 | 1 / 8 |
Outcome results
Primary
Daily Step Count (# Steps)
The daily step count of a participant as measured by a body worn pedometer.
Time frame: Three weeks
Population: numbers analyzed are different as there was issue with the data collection device and data were not recorded
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Daily Step Count (# Steps) | With RB | 2053 steps | Standard Deviation 776 |
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Daily Step Count (# Steps) | With AFO | 2745 steps | Standard Deviation 1613 |
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Daily Step Count (# Steps) | with C | 3453 steps | Standard Deviation 244 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Daily Step Count (# Steps) | with C | 2399 steps | Standard Deviation 268 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Daily Step Count (# Steps) | With RB | 2574 steps | Standard Deviation 82 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Daily Step Count (# Steps) | With AFO | 933 steps | Standard Deviation 671 |
| Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Daily Step Count (# Steps) | With AFO | 2043 steps | — |
| Ankle Osteoarthritis Patients: RB, Then C, the AFO | Daily Step Count (# Steps) | With AFO | 503 steps | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Daily Step Count (# Steps) | With AFO | 2745 steps | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Daily Step Count (# Steps) | with C | 3453 steps | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Daily Step Count (# Steps) | With RB | 2053 steps | — |
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
Time frame: Three weeks
Population: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data
Secondary
Fast Walking Speed
Fast walking speed as measured with a stop watch when walking a fixed distance.
Time frame: Three weeks
Population: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data
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
Time frame: three weeks
Population: issue with data collection device, data were not collected for all participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Foot and Ankle Ability Measure (FAAM) | C | 71 score on a scale | Standard Deviation 23 |
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Foot and Ankle Ability Measure (FAAM) | RB | 70 score on a scale | Standard Deviation 42 |
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Foot and Ankle Ability Measure (FAAM) | AFO | 92 score on a scale | Standard Deviation 1 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Foot and Ankle Ability Measure (FAAM) | AFO | 63 score on a scale | Standard Deviation 26 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Foot and Ankle Ability Measure (FAAM) | C | 70 score on a scale | Standard Deviation 35 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Foot and Ankle Ability Measure (FAAM) | RB | 60 score on a scale | Standard Deviation 7 |
| Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Foot and Ankle Ability Measure (FAAM) | AFO | 57 score on a scale | — |
| Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Foot and Ankle Ability Measure (FAAM) | C | 45 score on a scale | — |
| Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Foot and Ankle Ability Measure (FAAM) | RB | 64 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, Then C, the AFO | Foot and Ankle Ability Measure (FAAM) | C | 50 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, Then C, the AFO | Foot and Ankle Ability Measure (FAAM) | RB | 51 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, Then C, the AFO | Foot and Ankle Ability Measure (FAAM) | AFO | 30 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Foot and Ankle Ability Measure (FAAM) | AFO | 92 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Foot and Ankle Ability Measure (FAAM) | C | 72 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Foot and Ankle Ability Measure (FAAM) | RB | 70 score on a scale | — |
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
Time frame: three weeks
Population: issue with data collection device, data were not collected for all participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Numeric Pain Rating Scale | RB | 2.5 score on a scale | Standard Deviation 0.7 |
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Numeric Pain Rating Scale | C | 3.5 score on a scale | Standard Deviation 2.1 |
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Numeric Pain Rating Scale | AFO | 3 score on a scale | Standard Deviation 1.4 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Numeric Pain Rating Scale | AFO | 3.5 score on a scale | Standard Deviation 4.9 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Numeric Pain Rating Scale | RB | 3 score on a scale | Standard Deviation 4.2 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Numeric Pain Rating Scale | C | 5 score on a scale | Standard Deviation 2.8 |
| Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Numeric Pain Rating Scale | RB | 6 score on a scale | — |
| Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Numeric Pain Rating Scale | AFO | 5 score on a scale | — |
| Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Numeric Pain Rating Scale | C | 5 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, Then C, the AFO | Numeric Pain Rating Scale | C | 2 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, Then C, the AFO | Numeric Pain Rating Scale | AFO | 5 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, Then C, the AFO | Numeric Pain Rating Scale | RB | 7 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Numeric Pain Rating Scale | RB | 2.5 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Numeric Pain Rating Scale | AFO | 3 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Numeric Pain Rating Scale | C | 3.5 score on a scale | — |
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
Time frame: three weeks
Population: issue with data collection device, data were not collected for all participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | C | 54 score on a scale | Standard Deviation 2.8 |
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | RB | 50 score on a scale | Standard Deviation 2.6 |
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | AFO | 52 score on a scale | Standard Deviation 2.2 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | AFO | 22 score on a scale | Standard Deviation 4.3 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | C | 56 score on a scale | Standard Deviation 14.7 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | RB | 41 score on a scale | Standard Deviation 1 |
| Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | AFO | 41 score on a scale | — |
| Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | C | 61 score on a scale | — |
| Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | RB | 42 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, Then C, the AFO | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | C | 61 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, Then C, the AFO | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | RB | 46 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, Then C, the AFO | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | AFO | 45 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | AFO | 52 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | C | 54 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference | RB | 50 score on a scale | — |
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
Time frame: three weeks
Population: numbers analyzed are different as there was issue with the data collection device and data were not recorded
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | C | 50.9 score on a scale | Standard Deviation 8.7 |
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | RB | 50.35 score on a scale | Standard Deviation 2.2 |
| Ankle Osteoarthritis Patients: AFO, Then RB, Then C | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | AFO | 52 score on a scale | Standard Deviation 5.1 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | AFO | 22.5 score on a scale | Standard Deviation 7.4 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | C | 37.3 score on a scale | Standard Deviation 7.7 |
| Ankle Osteoarthritis Patients: C, Then RB, Then AFO | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | RB | 41.4 score on a scale | Standard Deviation 26.3 |
| Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | AFO | 41 score on a scale | — |
| Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | C | 37.9 score on a scale | — |
| Ankle Osteoarthritis Patients: C, Then AFO, Then RB | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | RB | 41.6 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, Then C, the AFO | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | C | 43.5 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, Then C, the AFO | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | RB | 45.6 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, Then C, the AFO | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | AFO | 45.6 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | AFO | 52 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | C | 50.9 score on a scale | — |
| Ankle Osteoarthritis Patients: RB, the AFO, Then C | Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | RB | 50 score on a scale | — |
Secondary
Qualitative Assessment of Device Preference
Do you have a preference to one of the treatments? Which one? Why/why not?
Time frame: Three Months
Population: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data
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?
Time frame: Three weeks
Population: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data
Secondary
Qualitative Assessment of Patient Satisfaction With the Device
Do you like the device? Why/why not?
Time frame: Three weeks
Population: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data
Secondary
Self-selected Walking Speed
Self-selected walking speed as measured with a stop watch when walking a fixed distance.
Time frame: Three weeks
Population: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data
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.
Time frame: Three weeks
Population: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data