Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients (RB/AFO)
Primary Purpose
Ankle Osteoarthritis, Healthy Ankles
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rocker bottom shoe
Ankle foot orthosis
Standard walking shoe
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Osteoarthritis focused on measuring Rocker bottom shoe, Ankle-foot orthosis, Ankle osteoarthritis
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
Sites / Locations
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Ankle osteoarthritis patients
Healthy control subjects
Arm Description
Ambulatory adult patients (18+) with ankle osteoarthritis.
Ambulatory adults (18+) with no known ankle osteoarthritis.
Outcomes
Primary Outcome Measures
Daily step count (# steps)
The daily step count of a participant as measured by a body worn pedometer.
Secondary Outcome Measures
Ankle joint range of motion (degrees)
Range of motion of the ankle joint in degrees as measured by biplane fluoroscopy and/ or CT scan
Self-selected walking speed
Self-selected walking speed as measured with a stop watch when walking a fixed distance.
Qualitative assessment of patient device wearing
Would you continue to wear the device if you were not part of the study? Why/why not?
PROMIS physical function
Self reported capability of physical function
PROMIS pain interference
Self reported consequences of pain on relevant aspects of one's life.
Foot and ankle Mobility measure FAAM
American Academy of Orthopaedic Surgeons Foot and Ankle Module questionnaire designed to assess foot and ankle conditions.
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.
Fast walking speed
Fast walking speed as measured with a stop watch when walking a fixed distance.
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.
Qualitative assessment of patient satisfaction with the device
Do you like the device? Why/why not?
Qualitative assessment of device preference
Do you have a preference to one of the treatments? Which one? Why/why not?
Full Information
NCT ID
NCT03524729
First Posted
March 29, 2018
Last Updated
June 10, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03524729
Brief Title
Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients
Acronym
RB/AFO
Official Title
Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Osteoarthritis, Healthy Ankles
Keywords
Rocker bottom shoe, Ankle-foot orthosis, Ankle osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ankle osteoarthritis patients
Arm Type
Active Comparator
Arm Description
Ambulatory adult patients (18+) with ankle osteoarthritis.
Arm Title
Healthy control subjects
Arm Type
Other
Arm Description
Ambulatory adults (18+) with no known ankle osteoarthritis.
Intervention Type
Device
Intervention Name(s)
Rocker bottom shoe
Intervention Description
Walking shoe with a anterior posterior rocker sole.
Intervention Type
Device
Intervention Name(s)
Ankle foot orthosis
Intervention Description
Dynamic carbon fiber ankle brace.
Intervention Type
Device
Intervention Name(s)
Standard walking shoe
Intervention Description
Standard walking shoe (control shoe) with no rocker sole.
Primary Outcome Measure Information:
Title
Daily step count (# steps)
Description
The daily step count of a participant as measured by a body worn pedometer.
Time Frame
Three weeks
Secondary Outcome Measure Information:
Title
Ankle joint range of motion (degrees)
Description
Range of motion of the ankle joint in degrees as measured by biplane fluoroscopy and/ or CT scan
Time Frame
Three weeks
Title
Self-selected walking speed
Description
Self-selected walking speed as measured with a stop watch when walking a fixed distance.
Time Frame
Three weeks
Title
Qualitative assessment of patient device wearing
Description
Would you continue to wear the device if you were not part of the study? Why/why not?
Time Frame
Three weeks
Title
PROMIS physical function
Description
Self reported capability of physical function
Time Frame
three weeks
Title
PROMIS pain interference
Description
Self reported consequences of pain on relevant aspects of one's life.
Time Frame
Three weeks
Title
Foot and ankle Mobility measure FAAM
Description
American Academy of Orthopaedic Surgeons Foot and Ankle Module questionnaire designed to assess foot and ankle conditions.
Time Frame
Three weeks
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
Three weeks
Title
Fast walking speed
Description
Fast walking speed as measured with a stop watch when walking a fixed distance.
Time Frame
Three weeks
Title
Timed-up-and-go
Description
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.
Time Frame
Three weeks
Title
Qualitative assessment of patient satisfaction with the device
Description
Do you like the device? Why/why not?
Time Frame
Three weeks
Title
Qualitative assessment of device preference
Description
Do you have a preference to one of the treatments? Which one? Why/why not?
Time Frame
Three Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce J. Sangeorzan, MD
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual participant data collected will be de-identified and placed in publically accessible online data repositories.
IPD Sharing Time Frame
Data will be posted ad-hoc on an ongoing basis.
IPD Sharing Access Criteria
Once posted, the data is available to the public.
Learn more about this trial
Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients
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