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

Ankle Osteoarthritis Clinical Trial

— RB/AFO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03524729
• Other study ID #: F2278-R
• Secondary ID: RX002278
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Osteoarthritis
• Healthy Ankles
• Osteoarthritis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily step count (# steps)	The daily step count of a participant as measured by a body worn pedometer.	Three weeks
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	Three weeks
Secondary	Self-selected walking speed	Self-selected walking speed as measured with a stop watch when walking a fixed distance.	Three weeks
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?	Three weeks
Secondary	PROMIS physical function	Self reported capability of physical function	three weeks
Secondary	PROMIS pain interference	Self reported consequences of pain on relevant aspects of one's life.	Three weeks
Secondary	Foot and ankle Mobility measure FAAM	American Academy of Orthopaedic Surgeons Foot and Ankle Module questionnaire designed to assess foot and ankle conditions.	Three weeks
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.	Three weeks
Secondary	Fast walking speed	Fast walking speed as measured with a stop watch when walking a fixed distance.	Three weeks
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.	Three weeks
Secondary	Qualitative assessment of patient satisfaction with the device	Do you like the device? Why/why not?	Three weeks
Secondary	Qualitative assessment of device preference	Do you have a preference to one of the treatments? Which one? Why/why not?	Three Months