Iterative Design of Custom Dynamic Orthoses

NCT04800510 | Completed Results FDA Device

• 2 other identifiers: 202002131CDMRP-PR172087
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. It is expected that carbon fiber braces can be designed to reduce forces in the ankle. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.

Conditions

Adult ALL; Healthy

Keywords

Gait Analysis; Ankle Foot Orthosis; Carbon Fiber; Biomechanics

Outcome Measures

Primary Outcomes (1)

• Joint Contact Stress-Time Exposure

  Joint contact stress-time exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model. The model included surface geometry of each participants tibia and talus. Contact stress -time exposure, measured in MPa-s, was calculated at 13 points across the gait cycle. Higher values indicate greater contact stress-time exposure.

  Baseline

Secondary Outcomes (15)

• Ankle Range of Motion

  Baseline

• Peak Ankle Moment

  Baseline

• Peak Ankle Power

  Baseline

• Plantar Force (Total Foot)

  Baseline

• Plantar Force (Forefoot)

  Baseline

Other Outcomes (9)

• Participant Device Preference

  Baseline

• Semi-Structured Interview

  Baseline

• Center of Pressure Velocity Timing

  Baseline

Study Arms (6)

NoCDO, CDOA, CDOB, CDOC

EXPERIMENTAL

Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC.

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

NoCDO, CDOA, CDOC, CDOB

EXPERIMENTAL

Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB.

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

NoCDO, CDOB, CDOA, CDOC

EXPERIMENTAL

Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC.

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

NoCDO, CDOB, CDOC, CDOA

EXPERIMENTAL

Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA.

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

NoCDO, CDOC, CDOA, CDOB

EXPERIMENTAL

Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB.

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

NoCDO, CDOC, CDOB, CDOA

EXPERIMENTAL

Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA.

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

Interventions

Carbon Fiber Custom Dynamic Orthosis (CDO) DEVICE

The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.

Also known as: Ankle Foot Orthosis

NoCDO, CDOA, CDOB, CDOC; NoCDO, CDOA, CDOC, CDOB; NoCDO, CDOB, CDOA, CDOC; NoCDO, CDOB, CDOC, CDOA; NoCDO, CDOC, CDOA, CDOB; NoCDO, CDOC, CDOB, CDOA

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18 and 50
• Shoe size between women's 8 and 13.5 or men's 6.5 and 12
• Healthy individuals without a current complaint of lower extremity pain, spine pain, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
• Full active range of motion of the bilateral lower extremities and spine
• Ability to hop without pain
• Ability to perform a full squat without pain
• Ability to read and write in English and provide written informed consent

You may not qualify if:

• Diagnosed moderate or severe brain injury
• Prior lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
• Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
• Visual or hearing impairment that would interfere with instructions given during testing
• Require an assistive device
• Wounds to the foot or calf that would prevent CDO use
• BMI greater than 35
• Pregnancy - Per participant self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

The University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Jason M. Wilken, PT, PhD
• Organization: The University of Iowa

jason-wilken@uiowa.edu

319-335-6857

Study Officials

• Jason M Wilken, PT, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the different design variations of each device, and will only be introduced to each device as CDO-A, CDO-B or CDO-C.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants will use three generic sized carbon fiber custom dynamic orthoses (CDOs). Each CDO will differ from the others in design and will be labeled as CDO-A, CDO-B and CDO-C. Participants will be randomly assigned to one of six CDO testing sequences (ABC, ACB, BCA, BAC, CAB, CBA) to prevent testing order from influencing study results.

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: April 21, 2021
• Primary Completion: June 25, 2022
• Study Completion: June 25, 2022
• Last Updated: January 30, 2026
• Results First Posted: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)