Orthotic Dose Response Study

NCT02629731 | Completed

• 1 other identifier: O2008-R
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

This study will investigate the effect of foot orthoses on two common conditions (ankle osteoarthritis and symptomatic adult onset flat feet) by using a custom biplane X-ray system the group has developed to very accurately and precisely quantify foot bone motion. The investigators will vary the design of the orthoses and subjects will be examined to find out which are most effective at improving function.

Conditions

Ankle Osteoarthritis; Flat Foot or Pes Planus

Keywords

foot; ankle; osteoarthritis; flat foot

Outcome Measures

Primary Outcomes (2)

• peak hindfoot eversion

  In the proposed experiments, normal and pathological subjects will be studied while they walk with seven different designs of in-shoe orthoses in standardized footwear. Subjecting individuals to different "doses" of orthotic correction will generate "dose-response" curves (i.e., the kinematic variables) that will then be associated with patient-specific characteristics.

  immediate

• peak tibial rotation in degrees

  In the proposed experiments, normal and pathological subjects will be studied while they walk with seven different designs of in-shoe orthoses in standardized footwear. Subjecting individuals to different "doses" of orthotic correction will generate "dose-response" curves (i.e., the kinematic variables) that will then be associated with patient-specific characteristics.

  immediate

Study Arms (3)

ankle OA

EXPERIMENTAL

inclusion criteria: 1) diagnosis of ankle OA or PTTD \[non-control subjects only\], 2) undergoing conservative care (i.e., prescribed a foot orthosis) and deemed not to be a surgical candidate, 3) between 18 and 80 years of age, and 4) ambulatory (able to walk at least 15 m) with the primary impediment to pain-free ambulation being ankle OA or PTTD

Device: custom orthoses with varying degrees of hindfoot posting

flat foot

EXPERIMENTAL

inclusion criteria: 1) diagnosis of flat foot, 2) undergoing conservative care (i.e., prescribed a foot orthosis) and deemed not to be a surgical candidate, 3) between 18 and 80 years of age, and 4) ambulatory (able to walk at least 15 m)

Device: custom orthoses with varying degrees of hindfoot posting

control

NO INTERVENTION

inclusion criteria: 1) between 18 and 80 years of age, and 2) ambulatory (able to walk at least 15 m)

Interventions

custom orthoses with varying degrees of hindfoot posting DEVICE

The base orthotic design will be altered for one foot (most symptomatic in the case of patients or randomly chosen for controls) to give variations from 5-degree lateral hindfoot posting to 10-degree medial in 2.5-degree increments.

ankle OA; flat foot

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of ankle OA or PTTD \[non-control subjects only\]
• undergoing conservative care (i.e., prescribed a foot orthosis) and deemed not to be a surgical candidate
• between 18 and 80 years of age
• ambulatory (able to walk at least 15 m) with the primary impediment to pain-free ambulation being ankle OA or PTTD

You may not qualify if:

• recent (\<1 year) surgical, neurological, metabolic or lower limb musculoskeletal problem that might impair the ambulation measures in the study, such as severe knee or hip osteoarthritis
• rheumatoid arthritis or other inflammatory disease
• foot ulceration or partial foot amputation
• inadequate cognitive or language function to consent or to participate
• lack of a telephone number or stable mailing address

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Washington: collaborator

Study Sites (2)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Flatfoot; Osteoarthritis

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arthritis; Joint Diseases; Rheumatic Diseases

Study Officials

• William R. Ledoux, PhD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 14, 2015
• Study Start: July 1, 2016
• Primary Completion: May 31, 2022
• Study Completion: December 29, 2023
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)