NCT03524729 (RB/AFO) is a NA clinical trial of Rocker bottom shoe in Ankle Osteoarthritis, sponsored by VA Office of Research and Development.

Who is sponsoring NCT03524729?

NCT03524729 is sponsored by VA Office of Research and Development.

What drugs are being tested in NCT03524729?

Interventions in NCT03524729: Rocker bottom shoe, Ankle foot orthosis, Standard walking shoe.

What condition does NCT03524729 study?

NCT03524729 studies Ankle Osteoarthritis, Healthy Ankles.

Is NCT03524729 still recruiting?

NCT03524729 is currently completed. Last updated 19 September 2024.

Are results published for NCT03524729?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-09-19 · How we verify

NCT03524729: RB/AFO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 19 September 2024

What this trial tests

NA trial testing Rocker bottom shoe in Ankle Osteoarthritis in 11 participants. Completed in 15 June 2023.

Timeline

1 January 2019

Primary endpoint
1 June 2022

15 June 2023

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	1 January 2019
Primary completion	1 June 2022
Estimated completion	15 June 2023
Sites	1 location across United States

Drugs / interventions tested

Rocker bottom shoe
Ankle foot orthosis
Standard walking shoe

Conditions studied

Ankle Osteoarthritis — all drugs for Ankle Osteoarthritis →
Healthy Ankles — all drugs for Healthy Ankles →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Ankle Osteoarthritis or Healthy Ankles. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Daily Step Count (# Steps) Primary · Three weeks

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

with C

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	3453	± 244
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	2399	± 268
Ankle Osteoarthritis Patients: RB, the AFO, Then C	3453	± NA

With AFO

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	2745	± 1613
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	933	± 671
Ankle Osteoarthritis Patients: C, Then AFO, Then RB	2043	± NA
Ankle Osteoarthritis Patients: RB, Then C, the AFO	503	± NA
Ankle Osteoarthritis Patients: RB, the AFO, Then C	2745	± NA

With RB

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	2053	± 776
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	2574	± 82
Ankle Osteoarthritis Patients: RB, the AFO, Then C	2053	± NA

Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Secondary · three weeks

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

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	50.9	± 8.7
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	37.3	± 7.7
Ankle Osteoarthritis Patients: C, Then AFO, Then RB	37.9	± NA
Ankle Osteoarthritis Patients: RB, Then C, the AFO	43.5	± NA
Ankle Osteoarthritis Patients: RB, the AFO, Then C	50.9	± NA

AFO

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	52	± 5.1
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	22.5	± 7.4
Ankle Osteoarthritis Patients: C, Then AFO, Then RB	41	± NA
Ankle Osteoarthritis Patients: RB, Then C, the AFO	45.6	± NA
Ankle Osteoarthritis Patients: RB, the AFO, Then C	52	± NA

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	50.35	± 2.2
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	41.4	± 26.3
Ankle Osteoarthritis Patients: C, Then AFO, Then RB	41.6	± NA
Ankle Osteoarthritis Patients: RB, Then C, the AFO	45.6	± NA
Ankle Osteoarthritis Patients: RB, the AFO, Then C	50	± NA

Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Secondary · 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

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	54	± 2.8
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	56	± 14.7
Ankle Osteoarthritis Patients: C, Then AFO, Then RB	61	± NA
Ankle Osteoarthritis Patients: RB, Then C, the AFO	61	± NA
Ankle Osteoarthritis Patients: RB, the AFO, Then C	54	± NA

AFO

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	52	± 2.2
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	22	± 4.3
Ankle Osteoarthritis Patients: C, Then AFO, Then RB	41	± NA
Ankle Osteoarthritis Patients: RB, Then C, the AFO	45	± NA
Ankle Osteoarthritis Patients: RB, the AFO, Then C	52	± NA

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	50	± 2.6
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	41	± 1
Ankle Osteoarthritis Patients: C, Then AFO, Then RB	42	± NA
Ankle Osteoarthritis Patients: RB, Then C, the AFO	46	± NA
Ankle Osteoarthritis Patients: RB, the AFO, Then C	50	± NA

Foot and Ankle Ability Measure (FAAM) Secondary · 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

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	71	± 23
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	70	± 35
Ankle Osteoarthritis Patients: C, Then AFO, Then RB	45	± NA
Ankle Osteoarthritis Patients: RB, Then C, the AFO	50	± NA
Ankle Osteoarthritis Patients: RB, the AFO, Then C	72	± NA

AFO

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	92	± 1
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	63	± 26
Ankle Osteoarthritis Patients: C, Then AFO, Then RB	57	± NA
Ankle Osteoarthritis Patients: RB, Then C, the AFO	30	± NA
Ankle Osteoarthritis Patients: RB, the AFO, Then C	92	± NA

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	70	± 42
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	60	± 7
Ankle Osteoarthritis Patients: C, Then AFO, Then RB	64	± NA
Ankle Osteoarthritis Patients: RB, Then C, the AFO	51	± NA
Ankle Osteoarthritis Patients: RB, the AFO, Then C	70	± NA

Numeric Pain Rating Scale Secondary · 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

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	3.5	± 2.1
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	5	± 2.8
Ankle Osteoarthritis Patients: C, Then AFO, Then RB	5	± NA
Ankle Osteoarthritis Patients: RB, Then C, the AFO	2	± NA
Ankle Osteoarthritis Patients: RB, the AFO, Then C	3.5	± NA

AFO

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	3	± 1.4
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	3.5	± 4.9
Ankle Osteoarthritis Patients: C, Then AFO, Then RB	5	± NA
Ankle Osteoarthritis Patients: RB, Then C, the AFO	5	± NA
Ankle Osteoarthritis Patients: RB, the AFO, Then C	3	± NA

Group	Value	95% CI
Ankle Osteoarthritis Patients: AFO, Then RB, Then C	2.5	± 0.7
Ankle Osteoarthritis Patients: C, Then RB, Then AFO	3	± 4.2
Ankle Osteoarthritis Patients: C, Then AFO, Then RB	6	± NA
Ankle Osteoarthritis Patients: RB, Then C, the AFO	7	± NA
Ankle Osteoarthritis Patients: RB, the AFO, Then C	2.5	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ankle Foot Orthosis (AFO)

Serious: 0/8 (0%)

Deaths: 0/8

Healthy Control Subjects

Serious: 0/1 (0%)

Deaths: 0/1

Rocker Bottom Shoe (RB)

Serious: 0/8 (0%)

Deaths: 0/8

Control (C)

Serious: 1/8 (13%)

Deaths: 0/8

Serious adverse events (1 terms)

Reaction	System	Ankle Foot Orthosis (AFO)	Healthy Control Subjects	Rocker Bottom Shoe (RB)	Control (C)
infection	Skin and subcutaneous tissue disorders	—	—	—	—

Most-reported serious reactions: infection.

Data from ClinicalTrials.gov NCT03524729 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Ankle Osteoarthritis

Currently open trials in the same condition.

NCT07417436 — Effects of Graded Motor Imagery in Individuals With Foot/Ankle Osteoarthritis · NA · recruiting
NCT06404801 — Development of Stance Control Orthotic Knee Joint For Improvement of KAFO Users · active not recruiting
NCT06525545 — Early MOtion Total Ankle Artroplasty · NA · recruiting
NCT06193057 — Comparison of Customized and Standard Total Ankle Prostheses · NA · recruiting
NCT06514196 — Post- Approval Hintermann Series H® Study 1 · active not recruiting

Other VA Office of Research and Development trials

Trials by the same sponsor.

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NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03524729 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 19 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03524729.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03524729: RB/AFO

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Ankle Osteoarthritis

Other VA Office of Research and Development trials

Verify against primary sources