Ankle OsteoarthritisRB/AFONCT03524729
Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients
A study testing Rocker bottom shoe, Ankle foot orthosis and Standard walking shoe in people with Ankle Osteoarthritis and Healthy Ankles, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Osteoarthritis, Healthy Ankles
- What is being tested?
- Rocker bottom shoe, Ankle foot orthosis and Standard walking shoe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For osteoarthritis patients:
- radiographic evidence of tibiotalar osteoarthritis
- ambulatory
- For healthy controls:
- ambulatory
- aged 18 or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients?
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.
Read the 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.
- Conditions
- Ankle Osteoarthritis, Healthy Ankles
- Being tested
- Rocker bottom shoe, Ankle foot orthosis, Standard walking shoe
- Keywords
- Rocker bottom shoe, Ankle-foot orthosis, Ankle osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocker bottom shoeDevice
Walking shoe with a anterior posterior rocker sole.
Ankle foot orthosisDevice
Dynamic carbon fiber ankle brace.
Standard walking shoeDevice
Standard walking shoe (control shoe) with no rocker sole.
| Study group | Role | What they receive |
|---|---|---|
| Ankle osteoarthritis patients | Active comparator | Ambulatory adult patients (18+) with ankle osteoarthritis. Receives: Device: Rocker bottom shoe; Device: Ankle foot orthosis; Device: Standard walking shoe |
| Healthy control subjects | Other | Ambulatory adults (18+) with no known ankle osteoarthritis. Receives: Device: Standard walking shoe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Step Count (# Steps)
The daily step count of a participant as measured by a body worn pedometer.
Measured: Three weeks
Secondary outcomes (11)
Ankle Joint Range of Motion (Degrees)
Range of motion of the ankle joint in degrees as measured by biplane fluoroscopy and/ or CT scan
Measured: Three weeks
Self-selected Walking Speed
Self-selected walking speed as measured with a stop watch when walking a fixed distance.
Measured: 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?
Measured: 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
Measured: three weeks
Fast Walking Speed
Fast walking speed as measured with a stop watch when walking a fixed distance.
Measured: 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.
Measured: Three weeks
Qualitative Assessment of Patient Satisfaction With the Device
Do you like the device? Why/why not?
Measured: Three weeks
Qualitative Assessment of Device Preference
Do you have a preference to one of the treatments? Which one? Why/why not?
Measured: 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
Measured: 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
Measured: 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
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start1 Jan 2019
- Primary completion1 Jun 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ankle OsteoarthritisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Bruce J. Sangeorzan, MD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524729
- Sponsor's protocol ID
- F2278-R
- Other IDs
- RX002278
- Acronym
- RB/AFO
- Status last verified
- Aug 2024
- First submitted
- 29 Mar 2018
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected will be de-identified and placed in publically accessible online data repositories.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients?
- ClinicalTrials.gov ID
- NCT03524729
- Acronym / sponsor ID
- RB/AFO / F2278-R
- Conditions
- Ankle Osteoarthritis, Healthy Ankles
- Keywords
- Rocker bottom shoe, Ankle-foot orthosis, Ankle osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ankle osteoarthritis patients | Active comparator | Device: Rocker bottom shoe, Device: Ankle foot orthosis, Device: Standard walking shoeAmbulatory adult patients (18+) with ankle osteoarthritis. |
| Healthy control subjects | Other | Device: Standard walking shoeAmbulatory adults (18+) with no known ankle osteoarthritis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- radiographic evidence of tibiotalar osteoarthritis
- ambulatory
- ambulatory
- aged 18 or older
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocker bottom shoeWalking shoe with a anterior posterior rocker sole. | Device | Ankle osteoarthritis patients |
| Ankle foot orthosisDynamic carbon fiber ankle brace. | Device | Ankle osteoarthritis patients |
| Standard walking shoeStandard walking shoe (control shoe) with no rocker sole. | Device | Ankle osteoarthritis patients, Healthy control subjects |
Primary outcome
Daily Step Count (# Steps)
Time frame: Three weeks
The daily step count of a participant as measured by a body worn pedometer.
11 secondary outcomes
Ankle Joint Range of Motion (Degrees)
Time frame: Three weeks
Self-selected Walking Speed
Time frame: Three weeks
Qualitative Assessment of Patient Device Wearing
Time frame: Three weeks
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
Time frame: three weeks
Fast Walking Speed
Time frame: Three weeks
Timed-up-and-go
Time frame: Three weeks
Qualitative Assessment of Patient Satisfaction With the Device
Time frame: Three weeks
Qualitative Assessment of Device Preference
Time frame: Three Months
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Time frame: three weeks
Foot and Ankle Ability Measure (FAAM)
Time frame: three weeks
Numeric Pain Rating Scale
Time frame: three weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All individual participant data collected will be de-identified and placed in publically accessible online data repositories.
Related trials for Ankle Osteoarthritis
Recruiting
Effects of Graded Motor Imagery in Individuals With Foot/Ankle Osteoarthritis
Ankle Osteoarthritis, Foot Osteoarthritis
Not yet recruitingPhase 4
Suzetrigine for Postoperative Pain After Total Ankle Replacement
Ankle Osteoarthritis, Postoperative Pain
Not yet recruitingObservational study
Diagnostic Accuracy of Triphasic Bone Scan and SPECT/CT in Foot and Ankle Osteoarthritis
Osteoarthritis, Foot Osteoarthritis
Active, not recruitingObservational study
UK Infinity, Post-Market Clinical Follow-up Study
Arthritis, Rheumatoid, Post-traumatic Osteoarthritis
Active, not recruiting
Stability of Distal Tibiofibular Syndesmosis With or Without Fixation of Posterior Fragments in Bimalleolar Fractures
Ankle Fractures, Osteoarthritis, Ankle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce J. Sangeorzan, MD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocker bottom shoe, Ankle foot orthosis and Standard walking shoe in people with Ankle Osteoarthritis and Healthy Ankles, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Step Count (# Steps) (time frame: Three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.