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Musculoskeletal InjuryAFOHeelNCT04800484

The Effects of AFO Heel Height and Stiffness on Gait

A study testing Tall Soft, Tall Firm and Short Soft in people with Musculoskeletal Injury and Musculoskeletal Diseases, run by University of Iowa at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Tall Soft, Tall Firm and Short Soft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
7 Nov 2019to 1 Jan 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

United States1 site, 1 recruiting
  • University of Iowa

    Iowa City, Iowa, 52242

    Jason M Wilken, PT, PhD, 319-335-6857, Jason-wilken@uiowa.edu

    Kirsten M Anderson, PhD, 319-353-0431, kirsten-m-anderson@uiowa.edu

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Tall Soft, Tall Firm, Short Soft, Short Firm
Keywords
Gait Analysis, Ankle Foot Orthosis, Biomechanics
Medical subject headings
Musculoskeletal Diseases, Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tall SoftDevice

    Also called TS

    Tall heel wedge made of soft foam

  • Tall FirmDevice

    Also called TF

    Tall heel wedge made of firm foam

  • Short SoftDevice

    Also called SS

    Short heel wedge made of soft foam

  • Short FirmDevice

    Also called SF

    Short heel wedge made of firm foam

Study groups in NCT04800484
Study groupRoleWhat they receive
Arm 1:ExperimentalTesting Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 2:ExperimentalTesting Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 3:ExperimentalTesting Order: Clinical AFO, Tall Soft, Short Soft, Tall Firm, Short Firm, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 4:ExperimentalTesting Order: Clinical AFO, Tall Soft, Short Soft, Short Firm, Tall Firm, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 5:ExperimentalTesting Order: Clinical AFO, Tall Soft, Short Firm, Tall Firm, Short Soft, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 6:ExperimentalTesting Order: Clinical AFO, Tall Soft, Short Firm, Short Soft, Tall Firm, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 7:ExperimentalTesting Order: Clinical AFO, Tall Firm, Tall Soft, Short Soft, Short Firm, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 8:ExperimentalTesting Order: Clinical AFO, Tall Firm, Tall Soft, Short Firm, Short Soft, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 9:ExperimentalTesting Order: Clinical AFO, Tall Firm, Short Soft, Tall Soft, Short Firm, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 10:ExperimentalTesting Order: Clinical AFO, Tall Firm, Short Soft, Short Firm, Tall Soft, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 11:ExperimentalTesting Order: Clinical AFO, Tall Firm, Short Firm, Tall Soft, Short Soft, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 12:ExperimentalTesting Order: Clinical AFO, Tall Firm, Short Firm, Short Soft, Tall Soft, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 13:ExperimentalTesting Order: Clinical AFO, Short Soft, Tall Soft, Short Firm, Tall Firm, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 14:ExperimentalTesting Order: Clinical AFO, Short Soft, Tall Soft, Tall Firm, Short Firm, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 15:ExperimentalTesting Order: Clinical AFO, Short Soft, Tall Firm, Short Firm, Tall Soft, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 16:ExperimentalTesting Order: Clinical AFO, Short Soft, Tall Firm, Tall Soft, Short Firm, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 17:ExperimentalTesting Order: Clinical AFO, Short Soft, Short Firm, Tall Soft, Tall Firm, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 18:ExperimentalTesting Order: Clinical AFO, Short Soft, Short Firm, Tall Firm, Tall Soft, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 19:ExperimentalTesting Order: Clinical AFO, Short Firm, Tall Soft, Tall Firm, Short Soft, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 20:ExperimentalTesting Order: Clinical AFO, Short Firm, Tall Soft, Short Soft, Tall Firm, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 21:ExperimentalTesting Order: Clinical AFO, Short Firm, Tall Firm, Short Soft, Tall Soft, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 22:ExperimentalTesting Order: Clinical AFO, Short Firm, Tall Firm, Tall Soft, Short Soft, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 23:ExperimentalTesting Order: Clinical AFO, Short Firm, Short Soft, Tall Firm, Tall Soft, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm
Arm 24:ExperimentalTesting Order: Clinical AFO, Short Firm, Short Soft, Tall Soft, Tall Firm, NoAFO
Receives: Device: Tall Soft; Device: Tall Firm; Device: Short Soft; Device: Short Firm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Center of pressure velocity timing

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

    Measured: Baseline

  2. Center of pressure velocity magnitude

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

    Measured: Baseline

  3. Modified Socket Comfort Score (Comfort)

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

    Measured: Baseline

  4. Modified Socket Comfort Score (Smoothness)

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

    Measured: Baseline

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: Baseline

Secondary outcomes (3)
  1. Ankle Range of Motion

    Ankle range of motion (degrees) during gait.

    Measured: Baseline

  2. Peak Ankle Moment

    Peak ankle moment (Nm/kg) during gait.

    Measured: Baseline

  3. Peak Ankle Power

    Peak ankle power (W/kg) during gait.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start7 Nov 2019
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04800484
Sponsor's protocol ID
201811701
Acronym
AFOHeel
Status last verified
Oct 2026
First submitted
11 Mar 2021
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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