Clinical trial NCT03524729: Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients
Official title: Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Osteoarthritis
Healthy Ankles
Keywords: Rocker bottom shoe
Ankle-foot orthosis
Ankle osteoarthritis
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-05-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Daily Step Count (# Steps)
timeFrame: Three weeks
Secondary outcomes:
measure: Ankle Joint Range of Motion (Degrees)
timeFrame: Three weeks
measure: Self-selected Walking Speed
timeFrame: Three weeks
measure: Qualitative Assessment of Patient Device Wearing
timeFrame: Three weeks
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
timeFrame: three weeks
measure: Fast Walking Speed
timeFrame: Three weeks
measure: Timed-up-and-go
timeFrame: Three weeks
measure: Qualitative Assessment of Patient Satisfaction With the Device
timeFrame: Three weeks
measure: Qualitative Assessment of Device Preference
timeFrame: Three Months
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference
timeFrame: three weeks
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: three weeks
measure: Numeric Pain Rating Scale
timeFrame: three weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Bruce J. Sangeorzan, MD
role: PRINCIPAL_INVESTIGATOR
References: