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Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients (RB/AFO)

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ClinicalTrials.gov Identifier: NCT03524729
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ankle Osteoarthritis Healthy Ankles Device: Rocker bottom shoe Device: Ankle foot orthosis Device: Standard walking shoe Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients?
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ankle osteoarthritis patients
Ambulatory adult patients (18+) with ankle osteoarthritis.
 Device: Rocker bottom shoe
Walking shoe with a anterior posterior rocker sole.

Device: Ankle foot orthosis
Dynamic carbon fiber ankle brace.

Device: Standard walking shoe
Standard walking shoe (control shoe) with no rocker sole.
Healthy control subjects
Ambulatory adults (18+) with no known ankle osteoarthritis.
 Device: Standard walking shoe
Standard walking shoe (control shoe) with no rocker sole.


Outcome Measures
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Primary Outcome Measures :
  1. Daily step count (# steps) [ Time Frame: Three weeks ]
    The daily step count of a participant as measured by a body worn pedometer.


Secondary Outcome Measures :
  1. Ankle joint range of motion (degrees) [ Time Frame: Three weeks ]
    Range of motion of the ankle joint in degrees as measured by biplane fluoroscopy and/ or CT scan

  2. Self-selected walking speed [ Time Frame: Three weeks ]
    Self-selected walking speed as measured with a stop watch when walking a fixed distance.

  3. Qualitative assessment of patient device wearing [ Time Frame: Three weeks ]
    Would you continue to wear the device if you were not part of the study? Why/why not?

  4. PROMIS physical function [ Time Frame: three weeks ]
    Self reported capability of physical function

  5. PROMIS pain interference [ Time Frame: Three weeks ]
    Self reported consequences of pain on relevant aspects of one's life.

  6. Foot and ankle Mobility measure FAAM [ Time Frame: Three weeks ]
    American Academy of Orthopaedic Surgeons Foot and Ankle Module questionnaire designed to assess foot and ankle conditions.

  7. Numeric Pain Rating Scale [ Time Frame: 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.

  8. Fast walking speed [ Time Frame: Three weeks ]
    Fast walking speed as measured with a stop watch when walking a fixed distance.

  9. Timed-up-and-go [ Time Frame: 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.

  10. Qualitative assessment of patient satisfaction with the device [ Time Frame: Three weeks ]
    Do you like the device? Why/why not?

  11. Qualitative assessment of device preference [ Time Frame: Three Months ]
    Do you have a preference to one of the treatments? Which one? Why/why not?


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524729


Contacts
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Contact: Brittney C Muir, PhD (206) 277-3261 brittney.muir@va.gov
Contact: Patrick Aubin, PhD MS BS (206) 277-6310 patrick.aubin@va.gov

Locations
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United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA Recruiting
Seattle, Washington, United States, 98108
Contact: Brittney C Muir, PhD    206-277-3261    brittney.muir@va.gov   
Principal Investigator: Bruce J. Sangeorzan, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Bruce J. Sangeorzan, MD VA Puget Sound Health Care System Seattle Division, Seattle, WA
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03524729    
Other Study ID Numbers: F2278-R
RX002278 ( Other Grant/Funding Number: Department of Veterans Affairs )
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data collected will be de-identified and placed in publically accessible online data repositories.
Time Frame: Data will be posted ad-hoc on an ongoing basis.
Access Criteria: Once posted, the data is available to the public.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Rocker bottom shoe
Ankle-foot orthosis
Ankle osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases