N/A
Completed N=11
Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients
Ankle Osteoarthritis · Healthy Ankles
Source: ClinicalTrials.gov NCT03524729 ↗
Enrolled (actual)
11
Serious AEs
4.0%
Results posted
Sep 2024
Primary outcomePrimary: Daily Step Count (# Steps) — 3453; 2399; 3453; 2745 steps
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Step Count (# Steps) |
3453; 2399; 3453; 2745; 933; 2043 | — |
| SECONDARY Ankle Joint Range of Motion (Degrees) |
— | — |
| SECONDARY Self-selected Walking Speed |
— | — |
| SECONDARY Qualitative Assessment of Patient Device Wearing |
— | — |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function |
50.9; 37.3; 37.9; 43.5; 50.9; 52 | — |
| SECONDARY Fast Walking Speed |
— | — |
| SECONDARY Timed-up-and-go |
— | — |
| SECONDARY Qualitative Assessment of Patient Satisfaction With the Device |
— | — |
| SECONDARY Qualitative Assessment of Device Preference |
— | — |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference |
54; 56; 61; 61; 54; 52 | — |
| SECONDARY Foot and Ankle Ability Measure (FAAM) |
71; 70; 45; 50; 72; 92 | — |
| SECONDARY Numeric Pain Rating Scale |
3.5; 5; 5; 2; 3.5; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT03524729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.