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NCT Number: NCT03524729

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.

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Key information

Conditions

Ankle Osteoarthritis Healthy Ankles

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocker bottom shoe

Device

Walking shoe with a anterior posterior rocker sole.

Ankle foot orthosis

Device

Dynamic carbon fiber ankle brace.

Standard walking shoe

Device

Standard walking shoe (control shoe) with no rocker sole.

Primary outcomes

  1. Daily Step Count (# Steps)

    Time frame: Three weeks

    The daily step count of a participant as measured by a body worn pedometer.

Secondary outcomes

  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. Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function

    Time frame: three weeks

    Self reported capability of physical function Min: 0 Max: 100 A higher score indicates better physical function

  5. Fast Walking Speed

    Time frame: Three weeks

    Fast walking speed as measured with a stop watch when walking a fixed distance.

  6. 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.

  7. Qualitative Assessment of Patient Satisfaction With the Device

    Time frame: Three weeks

    Do you like the device? Why/why not?

  8. Qualitative Assessment of Device Preference

    Time frame: Three Months

    Do you have a preference to one of the treatments? Which one? Why/why not?

  9. Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference

    Time frame: 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

  10. Foot and Ankle Ability Measure (FAAM)

    Time frame: 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

  11. 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.

    scale of 1-10 higher= worse

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: RB/AFO

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
May 15, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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