The Effects of AFO Heel Height and Stiffness on Gait

NCT04800484 | Recruiting FDA Device

• 1 other identifier: 201811701
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Injury; Musculoskeletal Diseases; Peripheral Nervous System Diseases

Keywords

Gait Analysis; Ankle Foot Orthosis; Biomechanics

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

• Numerical Pain Rating Scale

  Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.

  Baseline

• Participant wedge preference

  The participant will rank order their preference for their Clinical AFO, Tall Soft, Tall Firm, Short Soft, or Short Firm wedge on a questionnaire.

  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 Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 2:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 3:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 4:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 5:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 6:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 7:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 8:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 9:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 10:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 11:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 12:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 13:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 14:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 15:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 16:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 17:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 18:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 19:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 20:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 21:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 22:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 23:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Arm 24:

EXPERIMENTAL

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

Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

Interventions

Tall Soft DEVICE

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:; Arm 20:; Arm 21:; Arm 22:; Arm 23:; Arm 24:; Arm 2:; Arm 3:; Arm 4:; Arm 5:; Arm 6:; Arm 7:; Arm 8:; Arm 9:

Tall Firm DEVICE

Tall heel wedge made of firm foam

Also known as: TF

Arm 10:; Arm 11:; Arm 12:; Arm 13:; Arm 14:; Arm 15:; Arm 16:; Arm 17:; Arm 18:; Arm 19:; Arm 1:; Arm 20:; Arm 21:; Arm 22:; Arm 23:; Arm 24:; Arm 2:; Arm 3:; Arm 4:; Arm 5:; Arm 6:; Arm 7:; Arm 8:; Arm 9:

Short Soft DEVICE

Short heel wedge made of soft foam

Also known as: SS

Arm 10:; Arm 11:; Arm 12:; Arm 13:; Arm 14:; Arm 15:; Arm 16:; Arm 17:; Arm 18:; Arm 19:; Arm 1:; Arm 20:; Arm 21:; Arm 22:; Arm 23:; Arm 24:; Arm 2:; Arm 3:; Arm 4:; Arm 5:; Arm 6:; Arm 7:; Arm 8:; Arm 9:

Short Firm DEVICE

Short heel wedge made of firm foam

Also known as: SF

Arm 10:; Arm 11:; Arm 12:; Arm 13:; Arm 14:; Arm 15:; Arm 16:; Arm 17:; Arm 18:; Arm 19:; Arm 1:; Arm 20:; Arm 21:; Arm 22:; Arm 23:; Arm 24:; Arm 2:; Arm 3:; Arm 4:; Arm 5:; Arm 6:; Arm 7:; Arm 8:; Arm 9:

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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)
• Greater than 2 weeks using their current AFO
• Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)
• Ability to walk at a slow to moderate pace
• AFO fits into traditional footwear
• Able to read and write in English and provide written informed consent

You may not qualify if:

• Pain \> 6/10 while walking during testing or an increase in pain during testing of \> 2/10.
• Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity).
• Disorder or disease that affects peripheral nerve function (e.g. diabetes, Charcot Marie Tooth).
• Limited contralateral lower limb function due to injury or neurological/musculoskeletal disorder.
• Use of a hinged/articulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist/stop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot.
• Use of an AFO that crosses the knee (Knee brace)
• Insufficient space in shoe to accommodate the tallest heel wedge and their AFO
• Visual or hearing impairments that limit walking ability or could limit the ability to comply with instructions given during testing
• Pregnancy - Per participant self-report. Due 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.
• Body Mass index \> 40.
• Ages: 18-70
• Daily AFO use to address below knee functional deficits that result from disease involving the peripheral nervous system (e.g. Charcot Marie Tooth, Multiple Sclerosis, diabetes)
• Greater than 2 weeks using their current AFO (unilateral or bilateral)
• Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)
• AFO fits into traditional footwear

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous 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; kirsten-m-anderson@uiowa.edu

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

Model Details: Participants will be evaluated in their clinically configured AFO and without an AFO if able. They will also complete evaluation with four provided heel wedge conditions in randomized order: tall soft, tall firm, short soft, short firm.

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: November 7, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)