Recruiting

Observational StudyThe Effects of AFO Heel Height and Stiffness on Gait

Sponsor:

University of Iowa

Code:

NCT04800484

Conditions

Musculoskeletal Injury

Musculoskeletal Diseases

Peripheral Nervous System Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Tall Soft

Tall Firm

Short Soft

Short Firm

Study Details

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

Study ID

NCT04800484

Start date

Nov 7, 2019

Status verified date

Dec, 2025

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

GROUP 1 Patient Inclusion criteria

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

GROUP 1 Patient Exclusion criteria

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.

GROUP 2 Patient Inclusion Criteria

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
Ability to walk at a slow to moderate pace
Able to read and write in English and provide written informed consent

GROUP 2 Patient Exclusion Criteria

Pain > 6/10 while walking 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)
Limited function due to limb injury (e.g. fracture, muscle and/or nerve injury)
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 impairment that limit walking ability or 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Arm 1:

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

experimental: Arm 2:

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

experimental: Arm 3:

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

experimental: Arm 4:

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

experimental: Arm 5:

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

experimental: Arm 6:

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

experimental: Arm 7:

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

experimental: Arm 8:

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

experimental: Arm 9:

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

experimental: Arm 10:

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

experimental: Arm 11:

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

experimental: Arm 12:

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

experimental: Arm 13:

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

experimental: Arm 14:

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

experimental: Arm 15:

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

experimental: Arm 16:

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

experimental: Arm 17:

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

experimental: Arm 18:

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

experimental: Arm 19:

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

experimental: Arm 20:

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

experimental: Arm 21:

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

experimental: Arm 22:

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

experimental: Arm 23:

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

experimental: Arm 24:

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

Interventions

Tall Soft

Tall heel wedge made of soft foam

Tall Firm

Tall heel wedge made of firm foam

Short Soft

Short heel wedge made of soft foam

Short Firm

Short heel wedge made of firm foam

Primary outcome measure

Center of pressure velocity timing [ Time Frame: Baseline ]
Center of pressure velocity magnitude [ Time Frame: Baseline ]
Modified Socket Comfort Score (Comfort) [ Time Frame: Baseline ]
Modified Socket Comfort Score (Smoothness) [ Time Frame: Baseline ]
Numerical Pain Rating Scale [ Time Frame: Baseline ]
Participant wedge preference [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Jason M Wilken, PT, PhD

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

Kirsten M Anderson, PhD

319-353-0431 kirsten-m-anderson@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Jason M Wilken, PT, PhD

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

Kirsten M Anderson, PhD

319-353-0431 kirsten-m-anderson@uiowa.edu

Principal Investigator:

Jason M Wilken, PT, PhD

More Information

Sponsor

University of Iowa

Last update posted

Dec 31, 2025

Last verified

Dec, 2025

Keywords

Gait Analysis
Ankle Foot Orthosis
Biomechanics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Iowa on 2025-12-31.