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NCT Number: NCT04800484

The Effects of AFO Heel Height and Stiffness on Gait

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Jason M Wilken, PT, PhD

CONTACT

[email protected]

319-335-6857

Jason M Wilken, PT, PhD

PRINCIPAL_INVESTIGATOR

Kirsten M Anderson, PhD

CONTACT

[email protected]

319-353-0431

Molly Pacha, MS, ATC, LAT

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tall Soft

Device

Tall heel wedge made of soft foam

Other names: TS

Tall Firm

Device

Tall heel wedge made of firm foam

Other names: TF

Short Soft

Device

Short heel wedge made of soft foam

Other names: SS

Short Firm

Device

Short heel wedge made of firm foam

Other names: SF

Primary outcomes

  1. Center of pressure velocity timing

    Time frame: Baseline

    Timing of peak center of pressure velocity (percent stance) during gait.

  2. Center of pressure velocity magnitude

    Time frame: Baseline

    Magnitude of peak center of pressure velocity (m/s) during gait.

  3. Modified Socket Comfort Score (Comfort)

    Time frame: Baseline

    Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.

  4. Modified Socket Comfort Score (Smoothness)

    Time frame: Baseline

    Smoothness scores range from 0 = least smooth to 10 = most smooth.

  5. Numerical Pain Rating Scale

    Time frame: Baseline

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

  6. Participant wedge preference

    Time frame: 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 outcomes

  1. Ankle Range of Motion

    Time frame: Baseline

    Ankle range of motion (degrees) during gait.

  2. Peak Ankle Moment

    Time frame: Baseline

    Peak ankle moment (Nm/kg) during gait.

  3. Peak Ankle Power

    Time frame: Baseline

    Peak ankle power (W/kg) during gait.

Other outcomes

  1. Activities-Specific Balance Confidence (ABC)

    Time frame: Baseline

    The ABC provides a standardized evaluation of balance confidence across a range of common daily tasks.

  2. PROMIS Patient reported outcomes for physical function

    Time frame: Baseline

    The Patient Reported Outcome Information System (PROMIS) physical function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.

Study contacts

Contact information is provided by the study sponsor or research team.

Jason M Wilken, PT, PhD

CONTACT

[email protected]

319-335-6857

Kirsten M Anderson, PhD

CONTACT

[email protected]

319-353-0431

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Acronym: AFOHeel

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2021
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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