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.
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
- Conditions the study is for
- Musculoskeletal Injury, Musculoskeletal Diseases, Peripheral Nervous System Diseases
- 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.
United States1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Arm 1: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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: | Experimental | Testing 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.
Center of pressure velocity timing
Timing of peak center of pressure velocity (percent stance) during gait.
Measured: Baseline
Center of pressure velocity magnitude
Magnitude of peak center of pressure velocity (m/s) during gait.
Measured: Baseline
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Measured: Baseline
Modified Socket Comfort Score (Smoothness)
Smoothness scores range from 0 = least smooth to 10 = most smooth.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
Ankle Range of Motion
Ankle range of motion (degrees) during gait.
Measured: Baseline
Peak Ankle Moment
Peak ankle moment (Nm/kg) during gait.
Measured: Baseline
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.
- First posted16 Mar 2021
- Study start7 Nov 2019
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Wilken, University of Iowa
- Investigators
- Jason M Wilken, PT, PhD, Principal investigator, University of Iowa
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