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Iterative Design of Custom Dynamic Orthoses

NCT ID: NCT04800510

Last Updated: 2023-12-05

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2022-06-25

Brief Summary

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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.

Detailed Description

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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.

Healthy adult participants will complete testing using three generic sized carbon fiber custom dynamic orthoses (CDOs) and with no CDO. Participants will be blinded to the design variation of each device and will only know them as CDO-A, CDO-B, or CDO-C. Testing will be completed under 4 conditions: No-CDO, CDO-A, CDO-B, CDO-C, with each bracing condition (A/B/C) representing a CDO design variant. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that changes to device design do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without CDO use, satisfaction with the devices, perception of comfort and smoothness between devices, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates in the floor. Forces between the foot and CDO will be measured using force sensing insoles, and muscle activity data will be collected using surface electromyography. Devices will be mechanically tested, and participant demographic and anthropometric data will be recorded.

The information obtained from this study will help refine the musculoskeletal model data input methods to be used in future studies. The knowledge that will be gained from this investigation has the potential to substantially improve the long-term efficacy and efficiency of the musculoskeletal model and help improve ankle foot orthosis

Conditions

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Adult ALL Healthy

Keywords

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Gait Analysis Ankle Foot Orthosis Carbon Fiber Biomechanics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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NoCDO, CDOA, CDOB, CDOC

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

Group Type EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type DEVICE

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

NoCDO, CDOA, CDOC, CDOB

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

Group Type EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type DEVICE

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

NoCDO, CDOB, CDOA, CDOC

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

Group Type EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type DEVICE

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

NoCDO, CDOB, CDOC, CDOA

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

Group Type EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type DEVICE

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

NoCDO, CDOC, CDOA, CDOB

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

Group Type EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type DEVICE

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

NoCDO, CDOC, CDOB, CDOA

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

Group Type EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type DEVICE

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

Interventions

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Carbon Fiber Custom Dynamic Orthosis (CDO)

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

Intervention Type DEVICE

Other Intervention Names

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Ankle Foot Orthosis

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Jason Wilken

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason M Wilken, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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The University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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202002131

Identifier Type: -

Identifier Source: org_study_id