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Outcome Measures

Primary Outcomes (2)

Peak Forefoot Force
Peak plantar forces, normalized to body mass (N/kg) will be measured across the forefoot (distal 40% of sensor).
Baseline
Forefoot Force Impulse
Plantar force impulse, normalized to body mass (Ns/kg) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase.
Baseline

Secondary Outcomes (6)

Peak Midfoot Force
Baseline
Midfoot Force Impulse
Baseline
Peak Hindfoot Force
Baseline
Hindfoot Force Impulse
Baseline
Peak Total Foot Force
Baseline
+1 more secondary outcomes

Other Outcomes (3)

Numerical Pain Rating Scale
Baseline
Modified Socket Comfort Score (Comfort)
Baseline
Modified Socket Comfort Score (Smoothness)
Baseline

Study Arms (4)

No Visual Feedback

EXPERIMENTAL

Participants will walk in the study CDO without visual feedback of limb loading during gait.

Device: Carbon Fiber Custom Dynamic Orthosis

Visual Feedback of Forefoot Force

EXPERIMENTAL

Participants will walk in the study CDO while being provided visual feedback of forefoot loading loading during gait. Forefoot loading will be measured using wireless insoles placed in the CDO footplate.

Device: Carbon Fiber Custom Dynamic Orthosis

Visual Feedback of Cuff Force

EXPERIMENTAL

Interventions

Carbon Fiber Custom Dynamic OrthosisDevice

The carbon fiber custom dynamic orthosis (CDO) used in this study will consist of a semi-rigid carbon fiber footplate, a carbon fiber posterior strut, and a proximal cuff that wraps around the leg below the knee.

Also known as: Ankle Foot Orthosis

No Visual FeedbackVisual Feedback of Cuff ForceVisual Feedback of Forefoot Force

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Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

NONE

Masking Details

During to the differences in training methods, participants will not be blinded to the training method they are randomized to.

Purpose

OTHER

Intervention Model

PARALLEL

Model Details: In this study participants will walk without a CDO (NoCDO) and then will be randomized to one of three training groups: 1) no feedback, 2) visual feedback of forefoot force, and 3) visual feedback of cuff forces. Participants will walk at a controlled speed on a treadmill without the CDO, after initial introduction to the CDO, and after completing two rounds of training in the CDO.

Sponsor Type

OTHER

Responsible Party

SPONSOR INVESTIGATOR

PI Title

Associate Professor

Comparative Effect of Training Methods to Reduce Forefoot Loading in Carbon Fiber Custom Dynamic Orthoses

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Other Outcomes (3)

Study Arms (4)

No Visual Feedback

Visual Feedback of Forefoot Force

Visual Feedback of Cuff Force

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

NoCDO

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Other Outcomes (3)

Study Arms (4)

No Visual Feedback

Visual Feedback of Forefoot Force

Visual Feedback of Cuff Force

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

NoCDO

You may not qualify if:

Data Sharing

Source record

Locations