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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of AFO Heel Height and Stiffness on Gait
- ClinicalTrials.gov ID
- NCT04800484
- Acronym / sponsor ID
- AFOHeel / 201811701
- Keywords
- Gait Analysis, Ankle Foot Orthosis, Biomechanics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 24
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO |
| Arm 2: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO |
| Arm 3: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Tall Soft, Short Soft, Tall Firm, Short Firm, NoAFO |
| Arm 4: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Tall Soft, Short Soft, Short Firm, Tall Firm, NoAFO |
| Arm 5: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Tall Soft, Short Firm, Tall Firm, Short Soft, NoAFO |
| Arm 6: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Tall Soft, Short Firm, Short Soft, Tall Firm, NoAFO |
| Arm 7: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Tall Firm, Tall Soft, Short Soft, Short Firm, NoAFO |
| Arm 8: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Tall Firm, Tall Soft, Short Firm, Short Soft, NoAFO |
| Arm 9: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Tall Firm, Short Soft, Tall Soft, Short Firm, NoAFO |
| Arm 10: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Tall Firm, Short Soft, Short Firm, Tall Soft, NoAFO |
| Arm 11: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Tall Firm, Short Firm, Tall Soft, Short Soft, NoAFO |
| Arm 12: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Tall Firm, Short Firm, Short Soft, Tall Soft, NoAFO |
| Arm 13: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Short Soft, Tall Soft, Short Firm, Tall Firm, NoAFO |
| Arm 14: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Short Soft, Tall Soft, Tall Firm, Short Firm, NoAFO |
| Arm 15: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Short Soft, Tall Firm, Short Firm, Tall Soft, NoAFO |
| Arm 16: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Short Soft, Tall Firm, Tall Soft, Short Firm, NoAFO |
| Arm 17: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Short Soft, Short Firm, Tall Soft, Tall Firm, NoAFO |
| Arm 18: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Short Soft, Short Firm, Tall Firm, Tall Soft, NoAFO |
| Arm 19: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Short Firm, Tall Soft, Tall Firm, Short Soft, NoAFO |
| Arm 20: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Short Firm, Tall Soft, Short Soft, Tall Firm, NoAFO |
| Arm 21: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Short Firm, Tall Firm, Short Soft, Tall Soft, NoAFO |
| Arm 22: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Short Firm, Tall Firm, Tall Soft, Short Soft, NoAFO |
| Arm 23: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Short Firm, Short Soft, Tall Firm, Tall Soft, NoAFO |
| Arm 24: | Experimental | Device: Tall Soft, Device: Tall Firm, Device: Short Soft, Device: Short FirmTesting Order: Clinical AFO, Short Firm, Short Soft, Tall Soft, Tall Firm, NoAFO |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tall SoftAlso: TSTall heel wedge made of soft foam | Device | 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 FirmAlso: TFTall heel wedge made of firm foam | Device | 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 SoftAlso: SSShort heel wedge made of soft foam | Device | 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 FirmAlso: SFShort heel wedge made of firm foam | Device | 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: |
Primary outcome
Center of pressure velocity timing
Time frame: Baseline
Timing of peak center of pressure velocity (percent stance) during gait.
Center of pressure velocity magnitude
Time frame: Baseline
Magnitude of peak center of pressure velocity (m/s) during gait.
Modified Socket Comfort Score (Comfort)
Time frame: Baseline
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Modified Socket Comfort Score (Smoothness)
Time frame: Baseline
Smoothness scores range from 0 = least smooth to 10 = most smooth.
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.
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.
3 secondary outcomes
Ankle Range of Motion
Time frame: Baseline
Peak Ankle Moment
Time frame: Baseline
Peak Ankle Power
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Musculoskeletal Injury
Enrolling by invitationPhase 4
PPP Versus Corticosteroid for Thigh Muscle Injuries
Thigh Muscle Injury, Thigh Injury
Active, not recruitingObservational study
Translation and Validation of the Limbs, Pain, Autonomy, Depression, Anxiety and Quality of Life Scales in Albanian
Musculoskeletal Pain, Autonomy
Not yet recruitingPhase 2
Post-traumatic Estradiol Administration and Care Evaluation (PEACE)
Chronic Musculoskeletal Pain, Sexual Assault
Recruiting
3D Hand Orthosis Trial
Hand Injuries and Disorders, Neurological Conditions
Not yet recruiting
X-BS Ortho Bone Graft Study
Orthopedic Disorder, Trauma Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason M Wilken, PT, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason M Wilken, PT, PhD (319-335-6857, jason-wilken@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of pressure velocity timing (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.