The Effects of AFO Heel Height and Stiffness on Gait

Not Applicable

Recruiting

• Conditions: Musculoskeletal Injury; Musculoskeletal Diseases; Peripheral Nervous System Diseases

• Registration Number: NCT04800484
• Lead Sponsor: University of Iowa

Brief 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.

Detailed Description

In this study the investigators to evaluate 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.

Two groups of subjects with impairments below the knee, that result in functional deficits and require daily AFO use, will be recruited for this study. The first group will have unilateral deficits associated with musculoskeletal injury or disease (Group 1), and the second group will have bilateral or unilateral deficits associated with peripheral nervous system disease (Group 2).

Lower limb forces and body motion will be assessed using computerized motion capture and force plates in the floor, as individuals walk over-ground. Small reflective markers placed on the participant's skin and force measuring plates in the floor will be used. Participants will walk with their clinically provided AFO, with added heel cushions of two different heights and stiffness's (4 conditions) at a controlled velocity and self-selected velocity. If able, they will walk without their AFO at a self-selected pace. Participants will be asked to provide information regarding their health condition and opinions of the conditions tested.

Study Timeline

• Study Start: 2019-11-07
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Modified Socket Comfort Score (Comfort)	Baseline	Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Center of pressure velocity timing	Baseline	Timing of peak center of pressure velocity (percent stance) during gait.
Numerical Pain Rating Scale	Baseline	Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Center of pressure velocity magnitude	Baseline	Magnitude of peak center of pressure velocity (m/s) during gait.
Modified Socket Comfort Score (Smoothness)	Baseline	Smoothness scores range from 0 = least smooth to 10 = most smooth.
Participant wedge preference	Baseline	The participant will rank order their preference for their Clinical AFO, Tall Soft, Tall Firm, Short Soft, or Short Firm wedge on a questionnaire.

Secondary Outcome Measures

Name	Time	Method
Peak Ankle Power	Baseline	Peak ankle power (W/kg) during gait.
Ankle Range of Motion	Baseline	Ankle range of motion (degrees) during gait.
Peak Ankle Moment	Baseline	Peak ankle moment (Nm/kg) during gait.

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States