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The Effects of AFO Heel Height and Stiffness on Gait

NCT04800484 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-31

No results posted yet for this study

Summary

The proposed study evaluates the effect of ankle foot orthosis (AFO) heel height and stiffness on the forces and motion of the lower limb during over-ground walking in individuals who use an AFO for daily walking. Previous studies suggest that heel height and stiffness effect limb loading, but these data and the analysis techniques applied are limited. In this study, heel cushions with different height and stiffness's (4 conditions) will be placed in participants shoes and they will walk at controlled and self-selected speeds. Participants will also walk with their AFO as configured prior to enrollment, and with no AFO if possible. The proposed study will provide evidence that can be used by clinicians and researchers to align braces that most effectively improve function during every-day walking.

Conditions

  • Musculoskeletal Injury
  • Musculoskeletal Diseases
  • Peripheral Nervous System Diseases

Interventions

DEVICE

Tall Soft

Tall heel wedge made of soft foam

DEVICE

Tall Firm

Tall heel wedge made of firm foam

DEVICE

Short Soft

Short heel wedge made of soft foam

DEVICE

Short Firm

Short heel wedge made of firm foam

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Jason M Wilken, PT, PhD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2027-01-01
Completion
2027-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04800484 on ClinicalTrials.gov