Trials Sponsors Conditions Drugs Pricing

Conditions

Musculoskeletal Diseases Musculoskeletal Injury Peripheral Nervous System Diseases

Keywords

Gait AnalysisAnkle Foot OrthosisBiomechanics

Outcome Measures

Primary Outcomes (6)

Center of pressure velocity timing
Timing of peak center of pressure velocity (percent stance) during gait.
Baseline
Center of pressure velocity magnitude
Magnitude of peak center of pressure velocity (m/s) during gait.
Baseline
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Baseline
Modified Socket Comfort Score (Smoothness)
Smoothness scores range from 0 = least smooth to 10 = most smooth.
Baseline

Secondary Outcomes (3)

Ankle Range of Motion
Baseline
Peak Ankle Moment
Baseline
Peak Ankle Power
Baseline

Other Outcomes (2)

Activities-Specific Balance Confidence (ABC)
Baseline
PROMIS Patient reported outcomes for physical function
Baseline

Study Arms (24)

Arm 1:

EXPERIMENTAL

Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO

Device: Tall SoftDevice: Tall FirmDevice: Short SoftDevice: Short Firm

Arm 2:

EXPERIMENTAL

Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO

Device: Tall SoftDevice: Tall FirmDevice: Short SoftDevice: Short Firm

Interventions

Tall SoftDevice

Tall heel wedge made of soft foam

Also known as: TS

Arm 10:Arm 11:Arm 12:Arm 13:Arm 14:Arm 15:Arm 16:Arm 17:Arm 18:Arm 19:Arm 1:

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ages: 18-70
Daily AFO use to address unilateral, below knee functional deficits that result from limb injury or musculoskeletal disease (e.g. fracture, muscle and/or nerve injury, ankle arthritis)

Sponsors & Collaborators

University of Iowa
Otherlead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Jason M Wilken, PT, PhDCONTACT319-335-6857 Jason-wilken@uiowa.edu

Kirsten M Anderson, PhDCONTACT319-353-0431 kirsten-m-anderson@uiowa.edu

Jason M Wilken, PT, PhDPRINCIPAL INVESTIGATOR

Molly Pacha, MS, ATC, LATSUB INVESTIGATOR

MeSH Terms

Conditions

Musculoskeletal DiseasesPeripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Study Officials

Jason M Wilken, PT, PhD
University of Iowa
PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason M Wilken, PT, PhD

CONTACT

319-335-6857 jason-wilken@uiowa.edu

Kirsten M Anderson, PhD

CONTACT

319-353-0431

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Masking Details: Participants will be blinded to the heel wedge conditions.
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 16, 2021

Study Start

November 7, 2019

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (3)

Other Outcomes (2)

Study Arms (24)

Arm 1:

Arm 2:

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

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You may not qualify if:

Data Sharing

Source record

Locations